Archive for May, 2020

Global Animal Genetic Market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of global animal genetics market for Global, Europe, North America, Asia Pacific, South America and Middle East & Africa.

Global Animal Genetic Marketis expected to rise from its estimated value of USD 4.39 billion in 2018 to an estimated value of USD 8.68 billion by 2026 registering a CAGR of 8.9% in the forecast period of 2019-2026.The upcoming market report contains data for historic years 2017, the base year of calculation is 2018 and the forecast period is 2019 to 2026.Few of the major market competitors currently working in the animal genetics market areNEOGEN CORPORATION, Zoetis, Envigo, Animal Genetics Inc., VetGen, Groupe Grimaud, Hendrix Genetics BV, EW Nutrition GmbH, Alta Genetics Inc., Genus, Topigs Norsvin, CRV Holding B.V., URUS, Trans Ova Genetics., Inguran LLC dba STgenetics., Semex, Beacon Automation Pty Ltd., Cogent, EVOLUTION International , Genex Services, LLC, Rockway, Inc., River Valley Dairy., ABS GLOBAL, INC., Anicam Enterprises Inc., Milk Source. among others

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Global Animal Genetic Market By Product (Live Animals (Poultry, Porcine, Bovines, Canine, Others), Genetic Material (Semens, Embroys)), Genetic Testing Services (DNA typing, genetic trait tests, genetic disease tests, and others), Geography (North America, South America, Europe, Asia-Pacific and Middle East and Africa) Industry Trends & Forecast to 2026;

Market Definition: Global Animal Genetic Market

Animal genetics is the branch of science which deals with the study of inheritance and gene variation in domestic and wild animals. Animal genetics are mostly used for genetic trait testing, DNA testing, and genetic disease traiting. The animal genetics market is expected to increase due to the fast demand, ingesting of animal proteins, and surge in urban population, which shows demand for meat products across the globe during the forecast period.

Market Drivers

Market Restraints

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Segmentation: Global Animal Genetic Market

By Product

By Genetic Testing Services

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Animal Genetic Market 2020: Industry Analysis and Detailed Profiles of Top Industry Players 3w Market News Reports - 3rd Watch News

DUBLIN--(BUSINESS WIRE)--The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.

Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

This report contains information on the following:

The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

Key Topics Covered

Part I: Technologies, Ethics & Regulations

Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit https://www.researchandmarkets.com/r/7h12ne

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The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -...

MacroGenics Reports Interim Clinical Data for Multiple Drug Candidates

MacroGenics (NASDAQ:MGNX) reported preliminary clinical data from the Phase 1 dose escalation and expansion clinical trial of MGD013 and from the Phase 1 dose expansion study of MGC018. The former drug candidate is aimed at treating patients with unresectable or metastatic neoplasms while the latter targets patients suffering from advanced solid tumors.

MGD013 aims to work by blocking PD-1 and LAG-3 checkpoint molecules to endure or reinstate the function of exhausted T cells. This dose escalation part of the study involved 53 patients suffering from advanced tumors. The patients were administered the drug candidate intravenously in cohorts of escalating flat doses of 1-1,200 mg every two weeks. For tumor-specific expansion cohorts, a flat dose of 600 mg every two weeks was selected.

As of the cutoff date of April 25, 2020, 205 eligible patients were administered the monotherapy, out of which 152 were found evaluable. Response Evaluation Criteria in Solid Tumors (RECIST) was used for measuring anti-tumor activity. For triple negative breast cancer, Objective Response Rate of 17 percent was observed while 39 percent patients showed Disease Control Rates. The ORR and DCR for epithelial ovarian cancer was 9 percent and 52 percent respectively. It was observed that the response to MGD013 monotherapy was linked with LAG-3 expression and an IFN- gene signature at baseline.

The combination cohort showed that the majority of responders whose baseline tumors were evaluated were negative for (or expressed low levels of) LAG-3 or PD-L1. This observation was in contrast to the findings in monotherapy cohort.

The other drug candidate MGC018 is being tested for solid tumors and involves delivering a DNA alkylating duocarmycin payload to dividing and non-dividing cells that express B7-H3. This ligand is found related to poor clinical outcome. The data cutoff date for the study was May 6, 2020, and by then 23 patients suffering from advanced solid tumors were enrolled in four different cohorts. The company is currently carrying out enrollment for a fifth cohort with 4 mg/kg every three weeks dose regime.

Out of the seven patients with advanced metastatic castration-resistant prostate cancer treated, five observed reductions in PSA levels of . 50%. Patients with mCRPC had been given a median of four therapies prior to MGC018, including taxane chemotherapy. The safety profile of the drug candidate has been generally manageable to date. Some of the most commonly occurring adverse events were skin and hematologic toxicities. 22 out of 24 patients reported at least one treatment related adverse event; however, no febrile neutropenia was observed.

MacroGenics is a clinical-stage biopharmaceutical company. The main focus of the company is to develop monoclonal antibody-based therapeutics for treating cancer. The company has its own proprietary suite of next-generation antibody-based technology platforms which is used for developing product candidates for different therapeutic domains.

Bristol-Myers Squibb (NYSE:BMY) reported that the FDA has sent a Refusal to File letter with regard to its Biologics License Application pertaining idecabtagene vicleucel or ide-cel. The drug candidate is being developed for treating patients suffering from heavily pre-treated relapsed and refractory multiple myeloma. The application was submitted in March 2020. Bristol-Myers Squibb is collaborating with bluebird bio (NASDAQ:BLUE) for developing this medicine.

The company stated that the FDA required the companies to provide further details related to the Chemistry, Manufacturing and Control (CMC) module of the BLA. However, it has not requested any additional clinical or non-clinical data. Bristol-Myers Squibb said that it plans to resubmit the BLA by the end of July 2020. Bristol CEO Giovanni Caforio said, We believe we submitted a completed dossier to the FDA, so what we are really discussing here is the level of detail the FDA has requested. However, the company still believes that it may accomplish expedited approval.

Bristol-Myers Squibb had acquired ide-cel as a part of its purchase of Celgene. The acquisition had brought five key pipeline assets to Bristol-Myers Squibb's portfolio. It is also one of the three key regulatory milestones required to be met for triggering Contingent Value Rights granted to the shareholders. The other two drug candidates are liso-cel and multiple sclerosis drug Zeposia (ozanimod). As per the terms of the acquisition, the approval for the drug candidate is required to be obtained by March 2021.

Ide-cel is a B-cell maturation antigen directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The drug candidate was granted Breakthrough Therapy Designation (BTD) by the FDA. It also has Accelerated Assessment status and PRIority Medicines (PRIME) designation in European Union.

Enochian Biosciences (NASDAQ:ENOB) stock jumped up as the company provided updates about three of its pipeline candidates related to HIV and HBV. Two of the presentations are related to HIV while the remaining one is concerned with HBV. The HIV trials deal with genetic modification of cells for overexpressing ALDH1, an enzyme which helps them protect against low doses of chemo agent cyclophosphamide. For HBV, mouse studies have shown the potential of using caspase-9 enzyme.

Enochian has undertaken a novel approach towards treating HIV. The in-vivo study carried out by the company showed a 164 percent increase in engraftment of genetically modified cells. The study pertains to Hematopoietic stem-cell transplantation (HSCT) mechanism which has been tested for a number of diseases including HIV. Aldehyde dehydrogenase-1, or ALDH1, is a naturally occurring enzyme in human stem/progenitor cells. It is known to provide enhanced cellular resistance to cytotoxic agents such as cyclophosphamide (CY). The company is working on the hypothesis that low dosage of cyclophosphamide may help in increasing engraftment of human stem/progenitor cells.

The data demonstrated that the percentage of peripheral blood granulocytes overexpressing ALDH1 increased from week 7 through 12 for all doses but was highest at 16mg/kg (95.2%) and 19mg/kg (93.5%). Further, the data also showed that ALDH1 expression increased in absolute number of granulocytes compared to control at all dose levels. The amount was the highest at 16mg/kg dosage. The average VCN in bone marrow cell was highest at 16mg/kg CY at the end of the study.

For its HBV treatment path, the company seeks to rely upon using the virus and cellular machinery for killing the infected cells. The study examined the expression of casp-9 in AAV2-treated HepG2 and the HBV-infected HepAD39 cell lines. AAV2 particles expressing Hijack RNA test AAV or green fluorescent protein were used for treating HBV-infected and uninfected hepatoma cell lines and primary human hepatocytes. The data showed 254% increase in casp-9 levels in the treated HBV-infected cells.

Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts works to be ahead of the curve.

That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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MacroGenics Reports Data, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha

MIKE TYSON has revealed he was injected with nearly-translucent blood in his bid to make a comeback... and the former heavyweight champ said it made him feel "weird".

The 53-year-old - who retired from boxing in 2005 - has announced his intention to dust off the gloves and return to compete in exhibition bouts.

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His return to action has been aided by stem-cell research therapy, that has left him feeling like a "different person".

He said: "You know what I had done? I had stem-cell research therapy.

"I feel like a different person but I can't comprehend why I feel this way. It's really wild what scientists can do."

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

In a recent interview with rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson opened up on the effects the treatment has had on him.

Commenting on the mental aspect of training for a fight for the first time in 15 years, he said: "My mind wouldnt belong to me.

"My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

Tyson was then asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

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BACK IN GLOVEHolyfield CONFIRMS Tyson talks over epic trilogy with pair close to deal

IF LOOKS COULD KILLMayweather training because he is 'very conscious about how he looks'

GO WITH THE FLOMayweather 'passionate about becoming a trainer' despite comeback rumours

MAY DAYNew footage of Floyd's win vs McGregor makes legend look even more impressive

PUSH AND PULPulev plotting Fury fight after Joshua having already beat up cousin Hughie

WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

Iron Mike has been called out by former rival Evander Holyfield to complete their trilogy following their two meetings in 1990s.

And his unusual methods for getting back in shape seem to be working.

Tyson is looking in incredible condition as he uploaded a clip of himself that showed off his ferocious power and speed.

See more here:
Mike Tyson reveals doctors injected him with translucent blood that left him feeling weird during stem cell - The Sun

MINNEAPOLIS, May 14, 2020 /PRNewswire/ --The challenges surrounding COVID-19 have impacted every aspect of healthcare, including ensuring the timely delivery of bone marrow and blood stem cells for transplant. Thanks to the generosity of the Lockheed Martin Corporation, however, patients are able to continue receiving life-saving transplants without interruption.

When the National Marrow Donor Program (NMDP)/Be The Match ran out of available European Union couriers to deliver life-saving cells to American patients and with tens of thousands of commercial flights canceled, Lockheed Martin stepped up to offer their corporate aircraft as an in-kind donation to support the federal government's COVID-19 response and relief efforts to ensure patients that life-saving products from European donors would arrive on time.

NMDP/Be The Match, operates the federally authorized program that matches unrelated volunteer donors with patients in the United States and abroad who have been diagnosed with leukemia and over 70 more otherwise fatal blood disorders and diseases.

In addition to matching donors and patients, one of the program's primary missions is coordinating the delivery of bone marrow domestically and internationally to patients in the United States and abroad. This life-or-death delivery has historically been accomplished by trained couriers hand carrying donated marrow in the passenger compartment of commercial aircraft from donor collection centers to the hospitals of patients all across the globe.

Patients who are scheduled to receive transplants in the coming days are already in the process of a carefully timed course of chemotherapy and radiation treatments designed to eliminate their existing immune systems in preparation for the transplantation of cells to create a healthy, new immune system. If the transportation of donor cells is interrupted, the consequences are fatal to these patients whose immune systems have been ablated.

"The incredible support from Lockheed Martin is a lifeline to our patients. For those awaiting bone marrow transplant, their very survival depends on the on-time delivery of these life-saving cells. By offering flight services, Lockheed Martin is helping us ensure that patients can continue the cells they need, exactly when they need them," said NMDP/Be The Match Chief Policy Officer Brian Lindberg.

As part of this partnership Lockheed Martin will be providing weekly air transport based on government medical need flying government medical teams to the most critical, high-priority locations around the country and/or flying to support bone marrow transport to help with the government's COVID-19 response.

NMDP/Be The Match has facilitated over 100,000 bone marrow transplants since 1987 to deliver cures for patients battling blood cancers and blood disorders. More than 50 percent of those transplants involve international donors or recipients.

About Be The MatchFor people with life-threatening blood cancerslike leukemia and lymphomaor other diseases, a cure exists. Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant. People can contribute to the cure as a member of the Be The Match Registry, financial contributor or volunteer. Be The Match provides patients and their families one-on-one support, education, and guidancebefore, during and after transplant.

Be The Match is operated by the National Marrow Donor Program (NMDP), a nonprofit organization that matches patients with donors, educates health care professionals and conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), so more lives can be saved. To learn more about the cure, visit BeTheMatch.orgor call 1 (800) MARROW-2.

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Lockheed Martin Steps Up To Help Save Lives And Support Be The Match During COVID-19 - Southernminn.com

Scientists have made embryosthat are a lot mouse and a little bit human.

With a little help, human stem cells can knit themselves into growingmouse embryos, populating thedeveloping liver, heart, retina and blood, researchers report May 13 in Science Advances.

Finicky human cells dont tend to grow well in other animals. But in one of the new mouse embryos, 4 percent of its cells were human the most thorough mixing between human and mouse yet.

That level of integration isquite striking to me, says Juan Carlos Izpisua Belmonte, a stem cell anddevelopmental biologist at the Salk Institute for Biological Studies in LaJolla, Calif. If other scientists can replicate the findings, it potentiallyrepresents a major advance, says Izpisua Belmonte, who was not involved in thestudy.

Headlines and summaries of the latest Science News articles, delivered to your inbox

Such chimeras could helpreveal how a single cell can give rise to an entire organism. More humanizedanimals could also prove valuable in studying diseases such as malaria that affectpeople more than other animals. And with more advances, chimeras couldultimately turn out to be a source of human organs.

Many scientists have hitroadblocks in growing human stem cells in mice or other animals, including pigs and cows(SN: 1/26/17). We have analyzedthousands of embryos but never saw robust chimeric contribution of human stemcells to mouse embryos beyond day 12, says stem cell and developmentalbiologist Jun Wu of the University of Texas Southwestern Medical Center inDallas, who wasnt involved in the study.

The new methods success comes down to timing, says neuroscientist and stem cell biologist Jian Feng. To grow and thrive in a mouse embryo, human stem cells developmental clocks must be turned back to an earlier phase called the nave stage. You need to basically push the human cells back to that phase, says Feng, of the University at Buffalo in New York.

Feng and his colleagues resetthe stem cells clocks by silencing a protein called mTOR for three hours. Thisbrief treatment shocked the cells back to their nave stage, presumably restoringtheir ability to turn into any cell in the body.

Researchers injected batchesof 10 to 12 of these more youthful human stem cells into mouse embryos containingabout 60 to 80 mouse cells, and allowed the embryos to develop for 17 days.

To outward appearances, these embryos grew normally despite harboring human cells. By tallying DNA that was specific to either mouse or human, the researchers found that human cells accounted for between 0.1 and 4 percent of the total cells in the embryos.

Human cells knittedthemselves into most developing tissues of the mouse, destined to become theliver, heart, bone marrow and blood. Human red blood cells were particularlyabundant in these mouse embryos, the researchers found. A small number of humancells showed up in tissue that will form a brain; one embryo had a swarm of humanphotoreceptors, eye cells that help detect light.

As far as the researcherscould tell, no human cells were among the cells that go on to form sperm andegg. The capacity of chimeras to reproduce is one of the worrisome ethicalquestions surrounding the organisms that scientists are still trying to figureout.

Once inside a mouse embryo, the normally sluggish developmental pace of the human cells sped up to match their hosts. Human stem cells typically are slow to turn into certain types of mature photoreceptors, liver cells or red blood cells, Feng says, but not when the human cells are inside a mouse embryo. You put the same human cells in a mouse embryo, [and] they go fast, Feng says. In 17 days, you get all these mature cells that would otherwise take months to get in a normal human embryo.

Other scientists emphasize that different laboratories need to repeat the results. But if it works a big if here this has big implications, Wu says.

Continue reading here:
New hybrid embryos are the most thorough mixing of humans and mice yet - Science News

Covid-19 has changed life as we know it. It has also accelerated already rapid trends in innovation and collaboration across the scientific community.

As the pandemic spreads across the globe, researchers are racing to develop diagnostics, vaccines and treatments. In the pursuit of new solutions to tackle SARS-CoV-2, the novel coronavirus that causes Covid-19, researchers have been turning to machine learning, AI and high-throughput experimental automation that aid in development. Another powerful tool they are using to accelerate the process is CRISPR. This gene-targeting and gene-editing technology, based on the mechanism that bacteria naturally use to fight viruses, is already proving useful in our joint fight against this new virus.

CRISPR Advances Covid-19 TestingWe know early detection of SARS-CoV-2 is essential to isolating infected patients and managing appropriate healthcare responses. Recently, researchers at MIT published a rapid CRISPR-Cas13-based COVID-19 detection assay protocol.Since CRISPR can be modified to target nearly any genetic sequence, it can be used to detect SARS-CoV-2 RNA in a patient sample. This assay utilizes an RNA-targeting CRISPR nuclease to help scientists detect the SARS-CoV-2 RNA from patient samples within 60 minutes. More recently, an improved assay was developed by researchers at MIT that was shown to provide faster and more robust results.

Utilizing another CRISPR nuclease that is thermostable, they developed a test that in one step copies the viral RNA in a patient sample, such as saliva, into the more stable DNA and then specifically identifies a SARS-CoV-2 gene sequence. Performing this point-of-care assay requires minimal lab equipment and resources, as it only needs a few reagents and a heat source, delivering results in as little as 40 minutes. Supplementing existing tests with new CRISPR-based approaches can broaden accessibility to Covid-19 testing, a key strategy for stopping the spread through track and trace efforts, as outlined by the World Health Organization.

CRISPR Helps Engineer Future TreatmentsPreviously, the genome-engineering power of CRISPR has been directed at fighting genetic diseases. But more recently, its also being harnessed to fight infectious diseases, now including the new coronavirus.

Understanding how a pathogenic disease operates at the host-pathogen interface is critical to developing new treatments. CRISPR-based genome engineering enables researchers to study how SARS-CoV-2 interacts with human cells and generate the appropriate cell models that could lead to faster discovery of a potential new treatment or an existing drug combination that may provide a treatment solution. Once a potential treatment is identified, CRISPR makes the next step drug target screening more efficient, advancing us more quickly to a viable treatment option.

As an example of this approach in action, researchers are exploring if CRISPR can be used to verify the functional relevance of human genes recently identified to interact with SARS-CoV-2 proteins. The investigation of the molecular mechanisms of the novel virus can ultimately help identify drug combinations that have the best potential to treat those infected.

Current Fight for the Future of Human HealthGenome engineering has been rapidly harnessed by academic and non-profit institutions, the biopharma industry, and scientific pioneers to develop Covid-19 testing and treatment solutions. CRISPR-based genome engineering enables researchers to study how SARS-CoV-2 interacts with human cells and generate the appropriate cell models that could lead to faster discovery of a potential new treatment or an existing drug combination that may provide a treatment solution.

Beyond this, the unprecedented innovation taking place in response to the Covid-19 pandemic will provide a foundation for improving human health in the future. Additionally, as technologies and understanding mature, new approaches, such as engineered cell therapies, will become part of the toolkit in future responses to global health challenges.

The current scientific response is representative of the future of life sciences a future where we integrate multiple technologies and disciplines including high throughput experimental automation, machine learning and agile, programmable tools such as CRISPR to fundamentally change our approach to research and development. We are seeing a new bar being set on the speed of science as the research community comes together, leveraging these technologies to respond to the Covid-19 pandemic at unprecedented velocity. Once the public health crisis subsides and the research halted by the pandemic resumes, the need for these transformative tools, technologies and approaches to life science research and development will be greater than ever.

Photo: wildpixel, Getty Images

Excerpt from:
How CRISPR can help us win the fight against the pandemic - MedCity News

CRISPR-Cas9 gene-editing is one of the most powerful tools available to modern science, but genetically-modified organisms (GMOs) in food are subject to some tight regulations. Now, researchers at North Carolina State University have created a new version of CRISPR that lets scientists edit crops without introducing new DNA, meaning they technically arent GMOs.

CRISPR-Cas9 allows for precise cut-n-paste edits to DNA in living cells. An RNA guide sequence directs the system to the target section of the genome. Once there, an enzyme, usually Cas9, snips out the sequence then deletes it or replaces it with something else. In this way, scientists can cut out problem genes, such as those that cause disease, or add new beneficial ones, such as giving crops better pest resistance.

For the new study, the researchers tweaked the process to make a cleaner edit in plants. It uses a process known as lipofection, where positively-charged lipids are used to build a kind of bubble around the Cas9 and RNA mechanisms. When injected into the organism, this bubble binds to and fuses with the cellular membrane, which pushes the CRISPR system into the cell itself. The method also uses a Cas9 protein itself, rather than the Cas9 DNA sequence.

The team tested the method by introducing fluorescent proteins into tobacco plants. And sure enough, after 48 hours the edited plants were glowing, indicating it had worked.

Wusheng Liu/NC State University

The new method has a few advantages over existing ones, the team says. Its easier to target the desired genetic sequence, and opens up new crops that couldnt be edited with existing methods. Plus, the protein only lasts for a few days before degrading, which reduces off-target edits.

But the most important advantage is that the resulting crops arent considered GMOs. Since the new method doesnt use Cas9 DNA, it doesnt introduce foreign DNA into the plant, which is an important distinction.

This was the first time anyone has come up with a method to deliver the Cas9 protein through lipofection into plant cells, says Wusheng Liu, lead author of the study. Our major achievement was to make that happen. Also, since many consumers prefer non-GMO specialty crops, this method delivers the Cas9 protein in a non-GMO manner.

As useful as genetic engineering can be, the term GMO has negative connotations for many people, who believe there are health concerns with eating these crops or meats. Other problems include the chance of modified plants or animals escaping into the wild, where they can spread their new genes to the native population, affecting ecosystems.

As such, the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have regulations on which edited crops and animals are allowed in food. And theyve decided that the line is drawn at introducing foreign genes into an organism.

It makes sense. Humans have been genetically-engineering plants and animals for millennia, through selective breeding. Many of our most widely-eaten crops are bigger, tastier, and easier to eat or grow, to the point that they hardly resemble their wild counterparts anymore.

CRISPR and other gene-editing tools can be the next generation of this process. By removing problematic genes or ensuring that specific ones are turned on or off, scientists arent really creating anything new. Some individuals naturally have mutations that do the same thing all the scientists are really doing is removing the element of chance, genetically.

In 2015, a new type of salmon became the first genetically engineered animal approved by the FDA for human consumption. In 2016, a Swedish scientist grew, harvested and served up CRISPR cabbage after approval by the Swedish Board of Agriculture. In both cases, the products were allowed because they were functionally identical to wild-type organisms the scientists had just chosen beneficial genes from an existing natural pool, without introducing foreign DNA.

That said, the rules aren't the same everywhere. In 2018 the Court of Justice of the European Union somewhat controversially ruled that tough GMO laws applied to crops that had been edited even if new DNA hadn't been inserted. The issue will likely remain fragmented, but for the NC State team at least, their crops aren't GMOs according to their own country's regulations.

However, there are still some hurdles to overcome before the new method becomes viable. The team says that lipofection can only be done if the outer wall of the plant cell is removed first. This kind of plant cell, known as a protoplast, allows scientists to more easily tweak the genes, but it isnt possible in all types of crops, and even when it does work, its a complex process.

Instead, the researchers are exploring other options that dont require removing the cell wall at all. One such alternative is to use CRISPR to introduce the Cas9 protein into pollen grains, which can then go on to fertilize another plant. Some of the offspring will have the required genetic edits from day one.

The researchers plan to investigate this latter method in tomatoes and hemp first, before moving onto others.

The new study was published in the journal Plant Cell Reports.

Source: NC State University

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New CRISPR method edits crops without technically making them GMOs - New Atlas

ZUG, Switzerland and CAMBRIDGE, Mass., May 15, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that four abstracts have been accepted for poster presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, which will take place from June 22 to 24, 2020.

Session information is available online via the Annual Meeting Itinerary Planner through the AACR website at http://www.aacr.org.

Title: Functional and single-cell assessment of CRISPR-modified CAR-T cells from NSCLC patients and healthy donors Session Title: Adoptive Cell Therapy 1E-Poster Number: 879Abstract Number: 3338

Title: Allogeneic CAR-T cell products containing 10 gene edits using CRISPR/Cas9 can retain full functionality in vivo and in vitro Session Title: Adoptive Cell Therapy 1E-Poster Number: 880Abstract Number: 4647

Title: Allogeneic anti-PTK7 CAR-T cells for the treatment of solid tumors Session Title: Adoptive Cell Therapy 3E-Poster Number: 3243Abstract Number: 6231

Title: Targeting T cell lymphomas with CRISPR/Cas9-generated anti-CD70 allogeneic CAR-T cellsSession Title: Adoptive Cell Therapy 5E-Poster Number: 6595Abstract Number: 3308

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Investor Contact:Susan Kim+1 617-307-7503susan.kim@crisprtx.com

CRISPR Media Contact:Rachel EidesWCG on behalf of CRISPR+1 617-337-4167 reides@wcgworld.com

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CRISPR Therapeutics Announces Presentations at the American Association for Cancer Research 2020 Annual Meeting - GlobeNewswire

Researchers at ChristianaCare are looking to see how a newly approved coronavirus test using CRISPR could be used in Delaware, as they hope to learn how a patients genetic makeup can affect how the patient reacts to COVID-19.

Theres been a wide variance in the severity of COVID-19 symptoms.Many have required hospitalization and died from the disease while many others have experienced no symptoms at all. Others still have had much less common immune reactions to the virus like the rare inflammatory syndrome recently found in some children.

Dr. Eric Kmiec is Director of the Gene Editing Institute at ChristianaCare's Helen F. Graham Cancer Center & Research Institute. He, and others, believe this could be due to the genetic makeup of the patients.

It is possible for us to predict what types of people will be more susceptible? asked Kmiec. We know age and preconditions are absolute, and that is true, but now were seeing incredible variance among young people, millennials, even babies, and most of them dont have preexisting conditions that we can define. We might be able to define a genetic preexisting condition that may not even be apparent to the patient.

Kmiec says his team will be starting a research project in partnership with Stanford University and a few biotech companies to learn the relationship between an individuals genetic profile and how they respond to the virus.

He says the project will utilize CRISPR gene-editing technology developed at ChristianaCare to recreate genetic information on synthetic pieces of DNA on a chip.

This announcement comes as a new coronavirus test using CRISPR was fast-tracked through the approval process and okd by the Food and Drug Administration (FDA) just last week.

The so-called Sherlock test utilizes the gene-editing technology to detect the genome of the virus, and yields results in a couple hours.

Kmiec says the folks at MIT recently sent the test over.

Well be, sort of, working on it in the lab to see if theres a place for it in the future of what we call the long arch of testing here in Delaware, he said. The test has the ability to get to rural communities and hospitals that may not have such sophisticated instrumentation to carry out the tests that are currently on the market.

Delaware Medical Director Dr. Rick Hong couldnt say for sure if the state will be investing in the Sherlock test. But he says Delaware is looking into that as well as other testing technology for potential future purchase.

We appreciate our partners looking into other types of modalities, because I think we all need to work together on that, said Hong.

Kmiec says thatthough the price is subject to changeit appears the Sherlock test is less costly and requires less equipment than the qPCR tests currently being widely used. Be he adds Sherlock is rumored to be more sensitive and may run the risk of yielding more false positive results.

CRISPR technology in still in the early stages of clinical use. The technology raised controversy when Chinese scientists used it to change the genetic makeup of babies in 2018. It was used in the U.S. to treat a patient with a genetic disorder for the first time last year.

Kmiec says the Sherlock test was likely streamlined through the FDA process because of CRISPRs perceived future role in diagnostics.

The application here is for diagnostics, said Kmiec. So in terms of the rest of our concerns about off-site changes and its use to create mutations in patients, or something like that, that is off the table here.

Kmiec says ChristianaCare was already looking to move towards using CRISPR as tool to combat infectious diseases, but was pushed in that direction more quickly by the coronavirus outbreak.

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Gene editing tech CRISPR could be used to test for coronavirus and find who is most at-risk - Delaware First Media

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, May 14, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals Incorporated (VRTX) today announced that new data from two ongoing Phase 1/2 clinical trials of the CRISPR/Cas9 gene-editing therapy CTX001 in severe hemoglobinopathies have been accepted for an oral presentation at the EHA Congress, which will take place virtually from June 11-14, 2020.

An abstract posted online today includes 12 months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-111 trial in transfusion-dependent beta thalassemia (TDT) and 6 months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-121 trial in severe sickle cell disease (SCD). Updated data will be presented at EHA, including longer duration follow-up data for the first two patients treated in these trials and initial data for the second patient treated in the CLIMB-111 trial.

The accepted abstract is now available on the EHA conference website: https://ehaweb.org/congress/eha25/key-information-2/.

Abstract Title: Initial Safety and Efficacy Results With a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Hematopoietic Stem and Progenitor Cells in Transfusion-Dependent -Thalassemia and Sickle Cell DiseaseSession Title: Immunotherapy - ClinicalAbstract Code: S280

About the Phase 1/2 Study in Transfusion-Dependent Beta ThalassemiaThe ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with TDT. The study will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up study.

About the Phase 1/2 Study in Sickle Cell DiseaseThe ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with severe SCD. The study will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up study.

About CTX001CTX001 is an investigational ex vivo CRISPR gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD in which a patients hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth and is then replaced by the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and painful and debilitating sickle crises for SCD patients. CTX001 is the most advanced gene-editing approach in development for beta thalassemia and SCD.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex.

About the CRISPR-Vertex CollaborationCRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first treatment to emerge from the joint research program. CRISPR Therapeutics and Vertex will jointly develop and commercialize CTX001 and equally share all research and development costs and profits worldwide.

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

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CRISPR Forward-Looking StatementThis press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding CRISPR Therapeutics expectations about any or all of the following: (i) the status of clinical trials (including, without limitation, the expected timing of data releases) related to product candidates under development by CRISPR Therapeutics and its collaborators, including expectations regarding the data that is expected to be presented at the European Hematology Associations upcoming congress; (ii) the expected benefits of CRISPR Therapeutics collaborations; and (iii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with CTX001 at this time) not to be indicative of final trial results; the potential that CTX001 clinical trial results may not be favorable; that future competitive or other market factors may adversely affect the commercial potential for CTX001; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics most recent annual report on Form 10-K, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

About VertexVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com/ or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Vertex Special Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, information regarding the data that is expected to be presented at the European Hematology Association (EHA)s upcoming Congress. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the development of CTX001 may not proceed or support registration due to safety, efficacy or other reasons, and other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with theSecurities and Exchange Commissionand available through the company's website atwww.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

CRISPR Therapeutics Investor Contact:Susan Kim, +1 617-307-7503susan.kim@crisprtx.com

CRISPR Therapeutics Media Contact:Rachel EidesWCG on behalf of CRISPR+1 617-337-4167 reides@wcgworld.com

Vertex Pharmaceuticals IncorporatedInvestors:Michael Partridge, +1 617-341-6108orZach Barber, +1 617-341-6470orBrenda Eustace, +1 617-341-6187

Media:mediainfo@vrtx.com orU.S.: +1 617-341-6992orHeather Nichols: +1 617-839-3607orInternational: +44 20 3204 5275

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New Data for Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001 for Severe Hemoglobinopathies Accepted for Oral Presentation at the 25th European...

New Research Study On GlobalCRISPR and Cas Genes marketgives in-depth information on Market shares, growth opportunities, Industry Analysis, and Growth Aspects on competitive landscapes. The report helps readers to clearly understand the current and future status of the CRISPR and Cas Genes market from 2020 to 2029. This is the latest report covering the current market impact of COVID-19. The Coronavirus pandemic (COVID-19) has infected every aspect of life worldwide. This has brought with it numerous shifts in business conditions.

CLICK HERE !! Connect with our Analyst To Know What Is The Impact Of COVID 19 On CRISPR and Cas Genes Market and be Smart in Redefining Business Strategies

The CRISPR and Cas Genes Market research report covers market features, volume, and growth, segmentation, geographical breakdowns, market shares, trends, and plans for this business. It allows you to identify the products/services and end-users that drive revenue growth and profitability. The CRISPR and Cas Genes industry report lists the leading competitors and provides the game-changing strategic analysis of the key factors driving the market. The report includes the forecasts by 2020-2029, analysis by 2014-2019, and discussion of important industry trends, market size, market share predictions, and profiles of the top CRISPR and Cas Genes industry players:Addgene Inc, AstraZeneca Plc., Bio-Rad Laboratories Inc, Caribou Biosciences Inc, Cellectis S.A., Cibus Global Ltd, CRISPR Therapeutics AG, Editas Medicine Inc, eGenesis Bio, GE Healthcare, GenScript Corporation.

For Better Understanding, Download FREE Sample PDF Copy of CRISPR and Cas Genes Market Research Report : https://marketresearch.biz/report/crispr-and-cas-genes-market/request-sample

CRISPR and Cas Genes Market Segmentation based on product, application, end user, and region-

Segmentation on the basis of product:

Vector-based CasDNA-free CasSegmentation on the basis of application:

Genome EngineeringDisease ModelsFunctional GenomicsKnockdown/ActivationSegmentation on the basis of end user:

Biotechnology & Pharmaceutical CompaniesAcademic & Government Research InstitutesContract Research Organizations

The Report Covers Global regions North America, South America, Europe, and the Middle-East,& Africa and Asia-Pacific.

Research Study Offers a detailed analysis of this report:

Marketing strategy study and growth trends.

CRISPR and Cas Genes Market growth driven factor analysis.

Emerging recess segments and region-wise CRISPR and Cas Genes Markets.

An overall framework study, consisting of an evaluation of the parent market.

An empirical evaluation of the curve of the CRISPR and Cas Genes Market.

Major variations in CRISPR and Cas Genes Market dynamics.

Latest, Historical, and Expected size of the market from both prospect value and volume.

The report offers exclusive graphics and illustrative SWOT analysis of CRISPR and Cas Genes Market segments.

Do You Have Any Query Or Specific Requirement? Ask to Our Industry Expert @https://marketresearch.biz/report/crispr-and-cas-genes-market/#inquiry

Some Business Questions Answered in this Report:

1. What will the market size be in 2029?

2. What are the key factors driving the CRISPR and Cas Genes market?

3. Who are the key players in the market?

4. What are the challenges of market growth?

5. What are the market opportunities and threats facing key players?

6. What will be the growth rate in 2029?

7. Which strategies are used by top players in the CRISPR and Cas Genes market?

Share Your Questions Here For More Details On this Report or Customizations As Per Your Need:https://marketresearch.biz/report/crispr-and-cas-genes-market/#request-for-customization

Table of Contents:

1. Overview of the CRISPR and Cas Genes Industry.

2. Global CRISPR and Cas Genes Market Competitive aspects.

3. A share of Global CRISPR and Cas Genes Market.

4. CRISPR and Cas Genes Supply Chain Study.

5. Leading CRISPR and Cas Genes Company Profiles.

6. CRISPR and Cas Genes Globalization & Trade.

7. CRISPR and Cas Genes Suppliers and Buyers.

8. Import/Export scenario, Consumption by CRISPR and Cas Genes Major Countries.

9. Global CRISPR and Cas Genes Industry Forecast to 2029.

10. Key Growth factors and CRISPR and Cas Genes Market Outlook.

For Access Complete TOC, Please Click Here @https://marketresearch.biz/report/crispr-and-cas-genes-market/#toc

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CRISPR and Cas Genes Market Detailed Analysis 2020 : Impact Of COVID-19 and How Market Will Grow In The Upcoming Period 2020-2029? 3w Market News...

Global CRISPR and CRISPR-Associated (Cas) Genes Market: Snapshot

Over the years, biomedical researchers have increasingly focused on developing efficient and reliable methods for precise and targeted changes to virtually any point of genome of any living cell. Recent advances in the genome engineering has triggered several biological researches and translational applications. Economical manipulation and modification of genomic sequences enable molecular biologists identify and characterize key genetic determinants to facilitate the investigation of various biological processes.

Request Brochure of CRISPR and CRISPR-Associated (Cas) Genes Market Report for more Industry Insights @CLICK HERE NOW

Genome editing via clustered regularly interspaced short palindromic repeats (CRISPR)-CRISPR-associated (Cas) is considered as an innovative technique in programmable and high-throughput functional genomics. CRISPR-Cas system consists of pattern of repetitive sequences in the DNA of certain bacteria, who used it as an adaptive immune system to find a protection mechanism against invading foreign DNA.

In less than a decade, a host of novel targeted techniques and genomic engineering tools have been developed that facilitates precise and diverse genomic modifications in a variety of organisms and tissues. The recent tool having enormous potential in biomedical researches is the clustered regularly interspaced short palindromic repeats associated Cas9/sgRNA system, also called Cas9/sgRNA. Cas9 protein is an RNA guided endonuclease. Along with its variants it has generated considerable excitement versatile genomic engineering tool in the development of genetically edited (GE) crops. Primary areas research for this include examining gene function, understanding the regulatory signaling networks, and rewiring sgRNA for advance loss-of-function screening. This will help in combating biotic and abiotic stresses, thereby leading to the development of climate resilient crops and sustainable agriculture practices in the coming years.

Global CRISPR and CRISPR-Associated (Cas) Genes Market: Overview

In the past few years research and development of CRISPR or clustered regularly interspaced short palindromic repeats has allowed molecular biologists to designs solutions for repairing cells by genome editing. This method allows a change to a specific genome by the introduction of a new function or by correction of a mutation. The exceptional fidelity, simplicity of construction, and low cost has triggered a monumental demand for the several solutions offered by the global CRISPR and CRISPR-associated (Cas) genes market. The market is riding a wave of success as these factors have augmented the uptake of this method in several molecular biology laboratories.

The well-documented research report presents a fair case study of the global CRISPR and CRISPR-associated (Cas) genes market. The report includes a SWOT analysis and Porters five forces analysis, which help in understanding several facets of the global market in greater depth. Furthermore, analysts have used primary and secondary research methodologies, which ensure the authenticity of the facts. This information in the report has also been seconded by market experts with comments and recommendations about the subject matter. The comprehensive research report is aimed at guiding each of its readers to make well-informed business decisions.

Global CRISPR and CRISPR-Associated (Cas) Genes Market: Trends and Drivers

The products available in the global CRISPR and CRISPR-associated (Cas) genes market are DNA-free Cas and vector-based Cas. The widening applications of these are expected offer several lucrative opportunities to the global market. Out of various applications, genome engineering is expected to be a key contributor to the soaring revenue of the overall market in the near future. This trend will be attributable to eh increasing uptake of genome editing method for the therapeutic development and germline modifications. The report indicates that advancements in plant genome engineering will result in positive impact on the global market.

Analysts predict that CRISPR could be the next biotechnology treatment that has the ability to gradually replace the present single-antibody drugs. Genome engineering is anticipated to pick up a phenomenal pace in the coming years as it is being developed to build an immune response for targeting cancer. The widening application of these methods in the field of oncology is likely to change the game for the global market in the coming years.

Global CRISPR and CRISPR-Associated (Cas) Genes Market: Regional Outlook

In terms of geography, the global market is segmented into North America, Asia Pacific, Latin America, the Middle East and Africa, and Europe. North America is estimated to lead the global CRISPR and CRISPR-associated (Cas) genes market as the U.S. has shown a keen interest in developing effective therapeutics. Asia Pacific is also expected to offer several growth opportunities to the overall market as the region is facing a challenge of mounting unmet medical needs.

Get TOC of CRISPR and CRISPR-Associated (Cas) Genes Market Report for more Industry Insights @CLICK HERE NOW

Key Players Mentioned in the Report are:

The report has identified the following as the key operating players in the globalCRISPR and CRISPR-associated (Cas) genes market: Thermo Fisher Scientific, Inc., Caribou Biosciences, Inc., CRISPR THERAPEUTICS, Addgene, Mirus Bio LLC, Merck KGaA, Editas Medicine, GE Healthcare Dharmacon Inc., Takara Bio USA, Horizon Discovery Group plc, and Intellia Therapeutics, Inc.Analysts predict that these companies will focus on making strategic collaborations to ahead of the competition present in the overall market.

About TMR Research

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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CRISPR and CRISPR-Associated (Cas) Genes Market Competitive Landscape Analysis with Forecast by 2025 - News Distinct

These top-rated foot peel masks will have your feet looking perfectly preened in no time. (Getty Images)

Yahoo Lifestyle is committed to finding you the best products at the best prices. We may receive a share from purchases made via links on this page. Pricing and availability are subject to change.

With winter finally behind us, it means our feet could probably use some extra attention.

Boot seasonoften goes together with rough calluses and cracked heels, leaving them hard and tough after too much wear.

And while working from home has many benefits for foot health, youve probably noticed that your feet are more dry than usual.

Fortunately, there are now more options than ever for you to give your feet thebaby-soft feelof a salon treatment at home, without the need for any painful scrubbing.

Unlike moisturising masks that simply hydrate and soften hard skin, peeling masks are formulated to penetrate deep into rough spots, shedding the dead skin.

The majority of masks suggest you wear the it on your feet for 60 to 90 minutes. Your skin will then naturally peel over the next seven to 10 days.

With almost 2,000 five-star ratings on Amazon, this exfoliating foot mask has a unique French formula based on milk and plant extracts.

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The intensive foot peel that has hundreds of five-star reviews suggests you keep the socks on for one 60 minute application.

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One top review days: Great product! Only used it once and it left my feet super-smooth for weeks. I'll definitely be using it on a regular basis.

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Infused with Lactic Acid, the double-layer foot sock is designed to give your feet gentle exfoliation and deep moisturisation.

Wear it on your feet for 60-90 minutes for 7 to 10 consecutive days and your feet should be revitalised and supple.

Enriched with exfoliating fruit extracts that gently buff away dead skin cells, the formula is designed to be poured into a pair of supplied socks and left for an hour and a half while it works its magic, leaving you with silky smooth, soft feet and heels.

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Want to get rid of hard skin on your feet? Try one of these foot peel masks - Yahoo Lifestyle

XconomyBoston

Few drugs exist that treat amyotrophic lateral sclerosis, a progressive disease that kills the nerve cells that allow patients to initiate and control muscle movement.

QurAlis, a Cambridge, MA-based startup, has an ambitious plan to develop a number of precision therapies for the disease based on forms of the condition identified by genetic mutation or a biomarker that CEO Kasper Roet (pictured) hopes to could one day, in combination, help most ALS patients.

Now the company has raised $42 million from investors in the US, Europe, and Japanmoney that will fund a move from the LabCentral incubator in Kendall Square to its own office, more than double the companys headcount by years end, and get at least one of its programs into human testing sometime next year.

The company is leveraging stem cell research from company co-founders Kevin Eggan and Clifford Woolf, Harvard University professors whoby harvesting normal skin cells from ALS patients and turning them into cells such as the motor neurons that damages as the disease progresseshave created models with the same DNA and gene mutations as those patients in an effort to identify new therapeutics for known ALS genes.

Mutations in more than 25 human genes have been implicated in ALS, the company says, and its strategy is to systematically investigate treatments targeting specific disease-causing mechanisms in patient subgroups. Some of those genes are also believed to cause frontotemporal dementia, a common cause of dementia that QurAlis also plans to treat.

One program QurAlis is advancing is intended for patients whose neurons are damaged and killed by the overactivation of certain receptors for glutamate, a key neurotransmitter, in a process known as excitotoxicity.

The company is also working on a treatment intended to return the autophagy process, through which cells recycle unwanted or damage components, to normal functioning. To do so, QurAlis is looking to target the enzyme TBK1, which plays a key role.

Roet, in an interview, said the company views its strategy as analogous to that pursued by Bostons Vertex Pharmaceuticals (NASDAQ: VRTX), which has developed multiple drugs for forms of cystic fibrosis (CF) caused by certain mutations, and late last year received approval for a combination of those drugs for about 90 percent of all CF patients.

We have identified ALS as a disease that we think we understand now, at least for specific subgroups of patients, he said. We understand what is driving the disease and we are able to develop very specific therapies for those patients.

Eggan, Woolf, Roet, and Jonathan Fleming launched QurAlis just over two years ago with seed funding from investors including MP Healthcare Venture Management, the investment arm of Mitsubishi Tanabe Pharma; the investment arm of Amgen (NASDAQ: AMGN); and Alexandria Venture Investments. Mitsubishi Tanabe markets edaravone (Radicava), one of four FDA-approved treatments for ALS. The FDAs 2017 nod for the drug made it the only ALS therapy OKd in the past 20 years.

The Cambridge, MA-based company said the new capital, a Series A financing round, brings the total it has raised to $50.5 million. The investment was led by LS Polaris Innovation Fund, Mission BioCapital, Dutch firm Inkef Capital, and the Dementia Discovery Fund. New investors including Droia Ventures, which operates from Luxembourg and Belgium, Mitsui Global Investment, and Dolby Family Ventures also participated, as did earlier investors including Amgen, MP Healthcare, and Sanford Biosciences.

As part of the deal, LS Polariss Amy Schulman, Inkef Capitals Roel Bulthuis, Dementia Discovery Funds Jonathan Behr, and Droia Ventures Luc Dochez join Mission BioCapitals Johannes Fruehauf on the QurAlis board.

Earlier this year some of the same investors, including Amgen and Dolby Family Ventures, backed a Series A financing for EnClear Therapies, a spinout of QurAlis. That company raised $10 million to advance the development of a dialysis-like medical device designed to filter out harmful proteins in the cerebral spinal fluid of patients with neurodegenerative diseases.

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing - Xconomy

Its no accident that most people tend to sleep at night and are awake during the day. Our sleep-wake cycle is determined by our circadian rhythm, the bodys internal clock. Like old-time clocks, this internal clock needs to be reset every day, and is adjusted by first exposure to light in the morning.

Our circadian rhythms are controlled by multiple genes and are responsible for a variety of important functions, including daily fluctuations in wakefulness, body temperature, metabolism, digestion, and hunger. Circadian rhythm also controls memory consolidation (the formation of long-term memories occurs during sleep); the timing of hormone secretion (for example, the hormones controlling body growth work mostly at night); and body healing.

While the circadian sleep phase typically occurs at night, there are a range of times during which the sleep phase can occur, with some people programmed to sleep from early evening to early morning (known as morning larks), while others stay up late and sleep late (known as night owls). In addition to determining the timing of their sleep, a persons circadian tendency can also affect their choice of emotional coping skills, such as assertiveness or rationalization, and their predisposition to psychological disorders.

An irregular circadian rhythm can have a negative effect on a persons ability to sleep and function properly, and can result in a number of health problems, including mood disorders such as depression, anxiety, bipolar disorder, and seasonal affective disorder.

A recent study suggested that the night-owl type might have a greater predisposition to psychological disturbances. The authors found that the different circadian types were likely to have different coping styles to emotional stressors, and the ones adopted by the morning larks seemed to result in better outcomes and fewer psychological problems. This was a correlational study, so the reason for adopting different styles wasnt explained, but this study emphasizes the great impact circadian rhythms have on health and functioning.

Most of the evidence on the relationship between mood problems and circadian rhythm comes from studies of shift workers, whose sleep periods are out of sync with their circadian rhythm. Multiple studies show an increased prevalence of depression in night-shift workers. One meta-analysis showed that night-shift workers are 40% more likely to develop depression than daytime workers. Conversely, circadian rhythm disturbances are common in people with depression, who often have changes in the pattern of their sleep, their hormone rhythms, and body temperature rhythms.

Symptoms of depression may also have a circadian rhythm, as some people experience more severe symptoms in the morning. The severity of a persons depression correlates with the degree of misalignment of the circadian and sleep cycles.

Many successful treatments of depression, including bright light therapy, wake therapy, and interpersonal and social rhythm therapy, also directly affect circadian rhythms. (For the impact of circadian rhythm on the occurrence and treatment of depression related to bipolar disorder, please see this blog post on light therapy for bipolar disorder.)

Misalignment of the circadian rhythm may also provoke anxiety. Shift work results in a sleep disorder when your nighttime work shifts affect your ability to fall asleep and stay asleep, causing you to have excessive sleepiness during the day that in turn results in distress and affects your ability to function normally. Nurses with shift work disorder have increased anxiety scores on questionnaires. In a study on jet lag, in which travel changes the time of the external environment so that it is no longer synchronized with the internal clock and disrupts sleep, travelers had elevated anxiety and depression scores.

In seasonal affective disorder, people feel down and depressed in the winter months. Researchers believe this is due to changes in circadian rhythms as a result of seasonal changes in the length of daylight. People with seasonal affective disorder feel better using artificial morning light to realign their circadian rhythm with their sleep-wake cycle.

There is no way to change your circadian type since it is genetically determined, though there is some natural change that occurs during your lifespan. For example, our circadian sleep phase tends to shift later during adolescence (more owls) and advances earlier as we age (more like the lark).

If you find that your circadian sleep phase is out of sync with your desired schedule, you can either shift your social life to match your circadian rhythm, or try to shift your circadian rhythm to match your social life. It may be easier to try to shift your work and social life to your circadian rhythm: an example would be a person who has a delayed circadian rhythm and likes to sleep late and wake up late switching from a job with a 7 AM start time to a job which allows him or her to start working later around 10 AM. The other option would be talking to a sleep physician and doing ongoing work to try to shift your circadian rhythm to match your work and social life to an earlier wakeup time.

In general, the best way to improve your mood is to get a good nights sleep by matching your circadian rhythm to your sleep-wake cycle. Exposure to light in the morning helps synchronize the clock. Exposure to bright light at night, including bright artificial lights and screen time on laptops, tablets, and phones, can cause disruption in circadian rhythm and may contribute to worsening mood and negative consequences for health.

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Why your sleep and wake cycles affect your mood - Harvard Health Blog - Harvard Health

KARLA ANDERSON

Stay-at-home orders during this pandemic, have led to many long hours sitting in front of a computer at an unfamiliar desk or your kitchen table as you work from home or homeschool your kids. Then, you retreat to the couch to hide from the news only to binge-watch an entire Netflix series without getting up from your seat. A sedentary lifestyle isnt healthy, and it could put you at increased risk for developing a blood clot such as a deep vein thrombosis (DVT).

WHAT IS A DVT?

A blood clot is a clump of blood that has changed from a liquid to a gel-like or semisolid state. Clotting is a necessary process that can prevent you from losing too much blood in certain instances, such as when youre injured or cut. When a clot forms inside one of your veins, it wont always dissolve on its own. This can be a very dangerous and even life-threatening situation.

A blood clot in a large vein, usually in your leg, is called a deep vein thrombosis. A DVT can partly or completely block the flow of blood through the vein (causing swelling of the area below) and can move or break off and travel to the lungs. When the clot moves to the lungs its known as a pulmonary embolism and can cause death. A pulmonary embolism requires immediate medical attention.

When you sit for a long period of time, the blood flow to your legs slows down, and when your legs are still and hanging down, blood tends to pool in the muscular beds of the calf. These factors can make it easier for a clot to form and increase your risk for DVT.

SYMPTOMS OF A BLOOD CLOT

Many people that form a DVT never notice any symptoms. Symptoms include:

Swelling of your leg or arm

Pain or tenderness not caused by an injury

Skin that is warm to the touch, with swelling or pain

Redness of the skin, with swelling or pain

As mentioned, individuals with a DVT are at an increased risk for a pulmonary embolism. If you have difficulty breathing, chest pain that worsens with a deep breath, cough blood, or a faster than normal or irregular heartbeat, seek immediate attention.

PREVENTING BLOOD CLOTS

The good news is that blood clots can be prevented and treated if you understand your risk factors and get treatment quickly. Risk factors include:

Advanced age

Birth control methods that contain estrogen or hormone therapy

Cancer and cancer treatments

Chronic diseases such as heart and lung conditions, or diabetes

Family history of blood clots

Hospitalization for illness or surgery

Obesity

Severe trauma, such as a car accident

Smoking

Sitting too long, especially with legs crossed or confined to bed/wheelchair

Your physician will decide what treatment is best for you based on factors such as age, overall health, medical history, extent of the condition and symptoms. Treatment may include any of the following:

Medications such as blood thinners or clot-dissolving medications

Vena cava filter inserted to catch clots, usually only recommended for patients unable to take medication and blood thinners

Simple lifestyle modifications can help reduce your risk. Some simple tips to keep your blood flowing include:

Take short walk breaks as often as you can. Try taking a phone call on the go or using a headset so you can move freely around the home.

Try chair exercises. Simple leg raises, ankle flexing, and calf raises are low-impact ways to keep blood circulating.

Make time for play. When your work is done, include time to get active. Go for bike ride, walk with your family, or even play hide-and-seek with your kids in the yard its all about movement.

Its important that you understand how your lifestyle plays a role in your health. Talk with your doctor about your risk for blood clots and what you can do to prevent them.

Karla Anderson, MD, is a vascular surgeon with UPMC. She sees patients at the Heart & Vascular Institute, 740 High St., Suite 3001, Williamsport. For more information on blood clots and vascular health, visit UPMCSusquehanna.org/Vascular.

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Taking vitaminsseemed much more exciting when we were children. From the Flintstones brand to fruity liquids to gummies, getting your nutrients was much more of a treat than a task. Cut to two decades later, and vitamins are way less alluring. The good news is that gummies aren't just for kids anymorein fact, adult gummies have been on shelves for a long time, and their increasing popularity has encouraged more brands to jump on the bandwagon, making vitamins an enjoyable part of our day once again. Below, we interviewed a few top nutritionists and wellness experts and asked them to share the best gummy vitamins.

Take a look at what they had to say below.

Vitafusion Women's Supercharged Multi ($10)

"Vitafusion's SimplySupercharged Multivitamin is a good one," says Alissa Rumsey, MS, RD, founder of Alissa Rumsey Nutrition and Wellness. "You only need to take two gummies a day, and it only has three grams of sugar. It also has the simplest ingredients in the vitamin as well as having a good amount of vitamin D and B. Vitamin D is especially good for the winter months and for people who do not get a lot of sun on a daily basis."

Nature Made Vitamin C ($18)

"I prefer Nature Made gummy vitamins," says Lisa Moskovitz, RD, CDN. "They are USP verified, which means they are tested and meet specific requirements set out by the United States Pharmacopeia."

Olly Flawless Complexion ($14)

The Olly brand utilizes the research and savvy of naturopathic physician Taryn Forrelli, ND, who says that theseskin-geared gummies "deliver purifying antioxidants and minerals to support cell detox, hormone health, and proper metabolism, plus a concentrated botanical blend of spearmint, Aronia berry, and dandelion."

Hum Nutrition Hair Sweet Hair ($25)

Sarah Greenfield, RD, loves theseHum gummies because of their proven ingredients. "Some key nutrients include biotin, or B7, which helps the body break down proteins needed for hair growth," she explains. "One study found women experiencing hair loss had a biotin deficiency and adding biotin supplements helped increase hair growth. Zinc plays a role in immune function and also helps maintain the health of hair follicles, leading to the growth of healthier hair.Fo-ti, a Chinese herb is included to help decrease graying by increasing melanin (hair pigment) production."

Story continues

Nordic Naturals Omega-3 Gummy Fish ($30)

WhileAmy Shapiro MS, RD, CDN, advocates forgummy vitaminsprimarily for children or adults who have trouble swallowing pills, she's a fan of theNordic Naturals brand for gummies, especially its omega-3 blend. It's ideal for those with picky palates or vegetarians (eggs and fish like salmon, herring, and mackerel are high in omega-3).

Rainblow Light Rainbow Light Sunny Gummies ($27)

Shapiro is also a fan of the brand Rainbow Light and recommends its gummy varieties. They're totally natural with no artificial flavors, colors, or preservatives.

MyKind Organics Women's Multi Organic Fruit + Vitamin Chews ($25)

"I generally stay away from recommending gummies to clients as nutritional supplementation because many brands are actually packed with artificial ingredients and loads of sugars. However,Garden of Life brand makes the cleanest organic and non-GMO gummies on the market! Not to mention, it makes a variety for men, women, and kids that are loaded with necessary vitamins and minerals. Well done, Garden of Life!" says Dana Kofsky of Wellness Styled.

SmartyPants Adult Complete Daily Gummy Vitamins ($21)

"I absolutely adore SmartyPants gummy vitamins!The brand isorganic, sustainable, taste amazing and are family-owned.It makes it oh so easy to live sustainably by using post-recycled materials inits bottles in an effort to do itspart in protecting our planet. It is so important to trust in a brand and know that you are helping the planet along the way. SmartyPants has truly been an amazing part of me and my kids' daily routine for years," says Lo Roxburgh, author and wellness expert also known as the Body Whisperer.

Gem Daily Vitamin Subscription (one month) ($39)

Shauna Faulisi, a holistic nutritionist and founder of Soul Wellness Method in Los Angeles, doesn't recommend gummy vitamins as a first step to a healthy diet, preferring her clients to get vitamins and minerals through vegetables, clean fats, and proteins, and taking specific supplements based on their individualized needs. But she understands there may be limitations: "I know that it's not always possible to purchase and get on a regiment with many different supplements to take based on schedule, access to fresh foods, and monetary resourcesand I think one should embrace whatever added wellness regimen they can bring into their life, large or small, and feel proud about it!" she says. "My go-to recommendation for gummy vitamins are GemThe brand uses dates as a binder and sweetener, along with fiber and omega-filled chia seeds to bind.Gemhasa variety of vitamins and minerals as well as the adaptogen ashwagandha to help ease stress. It also hasone of my favorite anti-aging ingredients, the powerful antioxidant, astaxanthin. Gem is an incredibly well-thought-out daily supplement that uses only the purest, whole food ingredients to get the job done."

Next up: No Lie: These Vitamins Will Make Your Hair, Skin, and Nails Flawless

This post was updated by Sarah Yang.

This article originally appeared on The Thirty

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Nutritionists Say These Are the Best Gummy Vitamins - Yahoo Lifestyle

By Rocky Swift and Christine Soares

TOKYO: In the global hunt for coronavirus treatments, a Japanese antiviral medicine known as Avigan has won plaudits from Prime Minister Shinzo Abe and $128 million in government funding. But it's not the only game in town.

Camostat, a 35-year old pancreatitis drug made by Osaka-based Ono Pharmaceutical Co , has captured the interest of scientists in Japan and overseas with little fanfare or state assistance.The two compounds are among dozens undergoing testing around the globe and illustrate how the race to develop treatments and vaccines is still wide open despite politicians such as Abe and U.S. President Donald Trump promoting the potential benefits of certain drugs.

Gilead Science Inc's remdesivir has pulled into the lead after promising early trial results prompted emergency approval in the United States and Japan. While remdesivir has shown promise in reducing recovery times of hospitalised patients, the search continues for additional treatment options.

Abe's administration has pledged to give away free supplies of the drug, with some 43 countries making formal requests. Fujifilm chairman Shigetaka Komori is a longtime backer of Abe, though the cabinet has denied there is any connection between their relationship and the government's promotion of Avigan.The use of Avigan is decided by doctors and its approval will depend on medical and scientific evaluation in due course, said Fujifilm spokeswoman Kana Matsumoto. "The use of Avigan has nothing to do with the relationship between the Prime Minister and any particular company," she said.

DESTRUCTIVE TO FETUSES

Avigan, known generically as favipiravir, was developed in the late 1990s by a company that was later purchased by Fujifilm as part of its transition from photo businesses to healthcare. The drug works by short-circuiting the reproduction mechanism of certain RNA viruses such as influenza.

Avigan can be taken as a pill, which would make it more accessible than Gilead's remdesivir, currently administered only as an intravenous infusion. But the mechanism that makes Avigan effective against viruses also makes it destructive to the rapid cell growth of fetuses. After being tested against a range of viruses, Avigan was finally approved in Japan in 2014, but only for emergency use against flu epidemics, and it was licensed in China where it has since gone off patent.

Also clinically unproven is a camostat mesylate. Developed by Ono Pharmceutical, most famous for its blockbuster Opdivo cancer drug, camostat is a protease inhibitor that has been used primarily to treat pancreatitis and some types of cancer. But past laboratory and animal tests against SARS-CoV-1 showed it has antiviral functions, and it can be safely administered in high enough doses to match the concentrations that were effective in the lab.

A study published in the scientific journal Cell in March found that camostat blocks an enzyme essential for the entry of the coronavirus into the lungs, drawing researchers' interest. One of them was Dr. Joseph Vinetz, a professor at the Yale School of Medicine, who is ready to launch a clinical trial of camostat.

"It's got a 35-year track record, so it seemed to be a very safe drug," he said. "I said we've got to try it. I'm a physician and we're desperate for anything we can give to people."

Vinetz is still trying to raise money for the trial. "I'm 100% certain that we needed to start this trial a month ago. And we can have a definitive result in a month." Ono launched camostat, known commercially in Japan as Foipan, as a treatment for chronic pancreatitis in 1985 and postoperative reflux esophagitis in 1994. The company is now supplying the drug for COVID-19 studies in Japan and overseas, according to spokesman Yukio Tani.

Itzchak Levy at the Sheba Medical Center in Israel launched a self-funded camostat trial in April. "Up to now we recruited 14 patients and look forward to further recruitment," Levy said. Another trial being carried out at the University of Kentucky is testing whether camostat can inhibit the virus's preferred pathway into human cells, and with hydroxychloroquine - the malaria drug touted by Trump -- also block the back door, boosting the treatment's effectiveness.

Existing science behind camostat's mechanism of action and tolerance in patients "is why we were enthusiastic about its potential," said Elijah Kakani, an assistant professor at the university involved in the research. "However, at this point we need to temper our enthusiasm and be objective in our evaluation of this medication for the problem at hand."

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A tale of two Japanese drugs in tests to fight COVID-19 - ETHealthworld.com

CHICAGO May 14, 2020 (Thomson StreetEvents) -- Edited Transcript of Veru Inc earnings conference call or presentation Wednesday, May 13, 2020 at 12:00:00pm GMT

Veru Inc. - CFO & Chief Administrative Officer

* Mitchell S. Steiner

Veru Inc. - Chairman, President & CEO

Veru Inc. - Director of IR

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

Independent Portfolio Consultants, Inc. - Investment Strategist

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Good morning, ladies and gentlemen, and welcome to Veru Inc.'s investors' conference call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru Inc.'s Director of Investor Relations. Please go ahead.

Samuel Fisch, Veru Inc. - Director of IR [2]

Good morning. The statements made in this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the company's current assessment of the risks and uncertainties related to our businesses. Our actual results and future developments could differ materially from the results or developments in such forward-looking statements. Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the company's product portfolio, risks related to the ability of the company to obtain sufficient financing on acceptable terms we need to fund development and company operations, risks related to competition, government contracting risks and other risks detailed in the company's press releases, shareholder communications and Securities and Exchange Commission filings. For additional information regarding such risks, the company urges you to review its 10-Q and 10-K SEC filings.

I would now like to turn the conference over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO and President.

Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [3]

Thank you, Sam, and good morning. With me on this morning's call are Michele Greco, CFO and CAO; Phil Greenberg, Executive Vice President, Legal; and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Today, we will update you on the clinical development of our drug pipeline and the commercialization of our products as well as provide financial highlights for the second quarter fiscal year 2020.

Here is a brief update on the advancement of the prostate cancer drug pipeline, VERU-111 in prostate cancer. We have made significant progress in the clinical development program for VERU-111, a novel proprietary first-in-class oral-targeted antitubulin agent for men who have metastatic castration-resistant prostate cancer and have also become resistant to a novel androgen blocking agent, enzalutamide or abiraterone, but prior to IV chemotherapy, also referred to as the prechemotherapy stage. Unfortunately, there is a large number of these affected men.

According to published scientific reports, about 15% to 25% of men who have metastatic castration-resistant prostate cancer and started treatment with a novel androgen blocking agent will not respond all to this therapy. And about 75% to 85% of men will initially respond to treatment with an androgen blocking agent but their cancer will start progressing in about 9 to 15 months. So essentially, within 12 months, the majority of these men will have tumor progression. And a new orally available drug with a different mechanism of action that could be prescribed by urologists and medical oncologists, like the investigative drug VERU-111, is greatly needed for these men.

The Phase Ib portion of the Phase Ib/II clinical study enrolled 39 subjects from 7 clinical sites in the United States. A standard 3x3 design was used to establish the maximum tolerated dose to select a recommended clinical dose for the Phase II study and to assess the preliminary evidence of antitumor activity of VERU-111 in men with metastatic castration-resistant prostate cancer, who have also become resistant to at least 1 novel androgen blocking agent.

Oral dosing escalated from 4.5 to 81 milligrams in the 7 days of dosing, followed by 14 days of no drug for each 21-day cycle. After no dose-limiting toxicity was observed in the 7 days of dosing per cycle, the dose was then increased in the next cohort of patients. Additionally, the dosing schedule has expanded at 21 days of continuous dosing per cycle.

As for safety, the maximum tolerated dose of VERU-111 was determined to be 72 milligrams as 3 of 11 men had reversible grade 3 diarrhea, no grade 3 diarrhea was observed at doses of 63 milligrams or less per day. At doses of VERU-111 of 63 milligrams less per day, the most common adverse events were mild to moderate nausea, vomiting, diarrhea and fatigue. There were no reports of neurotoxicity and no neutropenia was observed at 63 milligrams and lower for the continuous oral dosing, daily dosing for a 21-day cycle.

Efficacy or antitumor activity was assessed by measuring serum PSA and by standard imaging with bone and CT scans. In the 8 men that received at least 4 21-day cycles of oral VERU-111 at any dose based upon their 21-day cycle baseline PSAs, 6 of the 8 men, which is 75%, had decreases in their PSA levels; 4 of 8 men had -- which is 50%, demonstrated greater than or equal to 30% decline in PSA; and 2 of 8 men, which is 25%, have greater or equal to 50% decline in PSA.

Based upon the Prostate Cancer Working Group 3 and the Response Evaluation Criteria in Solid Tumors, which is RECIST 1.1 criteria, these are conventional criteria, objective tumor responses we're seen in 2 of 8, which is 25% of patients, in soft tissue and bone, which were partial responses; and 5 of 8 men, 63%, had stable disease. Objective tumor responses and PSA declines lasted longer than 12 weeks. The primary end point used in the pivotal studies, efficacy studies for the treatment of metastatic castration-resistant prostate cancer is median time to cancer progression by imaging, bone and CT scans.

In the current study, the median duration of response or time to cancer progression has not been reached, as 7 of the 8 men are still being treated on the study with an average duration of response of 10 months. The range is between 6 and 14 months. There were an additional 3 subjects on the study that have not yet completed the 4-day -- the 4 21-day cycles. Therefore, there is a total of 10 men that is still being treated on the study.

To better understand the clinical relevance of these preliminary findings, it's important to note that all patients with metastatic castration-resistant prostate cancer at the time of enrollment in the Phase Ib had evidence of disease progression with at least 1 novel androgen blocking agent drug, whether it's abiraterone or enzalutamide. In a contemporary series recently reported in the scientific literature for this similar population of men, the median observed time to cancer progression, while being treated with an alternative androgen blocking agent, was about 3.4 months.

We have already initiated enrolling in an open-label Phase II portion of the clinical trial in approximately 26 men with metastatic castration and a novel androgen blocking agent-resistant prostate cancer prior to and prior to any IV chemotherapy using the recommended dose and schedule that was selected from the Phase Ib, which is the 63-milligram oral daily dosing for a continuous 21-day cycle. We are on track to complete enrollment this quarter.

We have the clinical safety and the antitumor data necessary from the Phase Ib clinical study to move forward to select the patient population, dose and schedule for the Phase III registration trial. We plan to meet with the FDA next quarter to discuss our proposed registration trial design, which is an open-label, single pivotal Phase III to evaluate the efficacy and safety of VERU-111 versus an alternative androgen blocking agent in men with metastatic castrate-resistant prostate cancer, who have developed cancer progression while receiving 1 androgen blocking agent.

These recent clinical results have allowed the company to potentially accelerate the clinical development of VERU-111 for the treatment of metastatic castration and androgen blocking agent of resistant prostate cancer. Consequently, Veru has changed its strategy of investing in an additional Phase II studies of other cancer types to focus on obtaining approval of VERU-111 as quickly as possible by focusing on the study design, obtaining FDA agreement and initiating and completing a Phase III registration trial for this unmet medical need. We look forward to updating everyone on the results of the FDA meeting.

We have strong IP protection for VERU-111. The composition of matter patents are issued, with expiry in 2031 in the U.S., with a possible patent extension to 2036. Method of use patents for prostate cancer in the U.S. are issued and expiry date is in 2031. We have issued composition and method of use patents in the major markets -- major world markets, including EU and Japan.

The prechemotherapy space in men, who have metastatic castration and androgen blocking agent-resistant prostate cancer, is currently one of the fastest-growing unmet medical need segments in advanced prostate cancer. There are currently no FDA-approved drugs for this indication. According to Accuvia, oral drugs like abiraterone and enzalutamide for advanced prostate cancer had over $6 billion in 2018 global annual sales and $3.1 billion in the U.S. Men who have failed these novel androgen blocking agents are the patients that VERU-111 is currently targeting, which we estimate represents a $5 billion annual global market.

In summary, the clinical development objective is to position VERU-111, which has a unique drug mechanism of action as it does not target the androgen receptor, as the next go-to drug in men who have metastatic castration-resistant prostate cancer and who have developed prostate cancer progression while being treated with an androgen blocking agent, like abiraterone or enzalutamide, but prior to IV chemotherapy. An advantage of VERU-111 is that it could be potentially prescribed by not only the medical oncologists but also the urologists, who is the usual physician managing these types of patients. We plan to present the full clinical data set in an upcoming major scientific meeting. These clinical results firmly position Veru as an oncology-focused biopharmaceutical company.

Next, I will update you on VERU-100, our proprietary peptide drug candidate for the treatment of hormone-sensitive advanced prostate cancer, an established multibillion-dollar global market. The target product profile of VERU-100 is commercially and scientifically compelling as having a number of anticipated advantages over currently available androgen deprivation therapies.

VERU-100 is a long-acting gonadotropin-releasing hormone, called GnRH antagonist, designed to be administered as a small-volume subcutaneous 3-month depot injection without a loading dose. As a GnRH antagonist, it is intended to immediately suppress testosterone, with no testosterone surge upon initial or repeated administration and no testosterone micro increases, which may adversely affect patient outcomes, a problem which potentially occurs with the approved LHRH agonist drugs like Lupron, Zoladex and Eligard. Currently, there are no GnRH antagonists commercially approved for treatment beyond 1 month, making VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot, which is an attractive choice for androgen deprivation therapy.

As previously mentioned, we have received agreement from FDA that the development program for VERU-100 may follow an expedited pathway. Based on this FDA input, the company plans to commence a single open-label, multicenter, dose-finding Phase II clinical trial in approximately 35 men, followed by a single open-label, multicenter Phase III clinical trial in only approximately 100 men. Veru is in the process of scaling up GMP manufacturing of drug product to prepare the clinical trial -- prepare for the clinical trial to VERU-100. Given the effects of COVID-19, it will be at least a quarter delay in this program. But otherwise, we expect the company's development program to resume as workers are returning to the GMP facility.

The company intends to submit an Investigational New Drug Application in the second half of 2020, so we can commence the open-label Phase II study by Q4 calendar year 2020. As it is an open-label Phase II study, we will be able to update you periodically on our progress towards reaching the primary end point, the reduction of testosterone to castrate levels in real-time during late 2020 and early 2021. The planned development pathway for VERU-100 agreed upon by FDA represents a lower-cost investment opportunity for a major product that can address the shortfalls of the current $2.6 billion global ADT market.

Our next product candidate in clinical trial is zuclomiphene, a novel proprietary oral nonsteroidal estrogen receptor agonist being evaluated to treat hot flashes, the most common side effect in men on androgen deprivation therapy for advanced prostate cancer and a major reason why men want to stop androgen deprivation therapy. We enrolled 93 men in a multicenter, double-blind, placebo-controlled dose finding study, Phase II study. And we're evaluating 2 doses, 10-milligram and 50-milligram zuclomiphene versus placebo. We reported positive top line interim results a few weeks ago. We determined that the 10-milligram dose was the no-effect dose, and the 50-milligram zuclomiphene demonstrated estrogenic activity and a reduction in the frequency of hot flashes from baseline to day 42.

We also reported on the safety from the current blinded aggregate clinical database from our placebo-controlled trial. Based on the study's interim findings, zuclomiphene appears to be well tolerated. We have not received any reports of gynecomastia, painful breasts or venous thromboembolic events, which are common side effects in men treated with high doses of estrogen.

Because of the continuing effects of COVID-19 and the related strains on the health system and regulatory agencies, we will be delayed in obtaining a face-to-face end-of-Phase II meeting with FDA for the zuclomiphene program in order to obtain agreement on the Phase III clinical program design that will be acceptable for approval. We will provide details of the design and timing of this study after we have our FDA meeting. Veru estimates that the peak U.S. revenue potential for zuclomiphene citrate to be between $580 million to $639 million. Currently, there are no FDA-approved drugs for this indication.

Although Veru is focused in prostate cancer and oncology, due to the urgency of the current global pandemic and the fact that VERU-100 has the potential to treat both SARS-CoV-2 infection and the associated reactive, severe lung inflammation in COVID-19 patients at risk for acute respiratory distress syndrome, the company is compelled to pursue this COVID-19 indication even though this indication is not the primary focus of our company. Drugs that target microtubules have broad antitumor -- antiviral activity by disrupting the intracellular transport of viruses, such as SARS-CoV-2, along the microtubules.

Microtubule trafficking is critical for viruses that cause infection. Furthermore, microtubule depolymerization agents that target alpha and beta tubulin subunits of microtubules, like a drug called colchicine, also have strong anti-inflammatory effects, including the potential to treat the cytokine-release syndrome, also known as the cytokine storm, which is induced by the SARS-CoV-2 viral infection that seems to be associated with the high COVID-19 mortality rates.

VERU-111 is an oral, first-in-class microtubule depolymerization agent that targets the colchicine binding site of alpha and beta tubulin subunits to inhibit microtubules. The company met with the FDA and has received agreement on the clinical development of VERU-111 as a potential dual, antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program Coronavirus Treatment Acceleration Program, CTAP. As reported yesterday, FDA granted Veru commission to proceed with a Phase II double-blind, randomized 1:1 placebo-controlled clinical trial evaluating daily doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients. There'll be 20 in the VERU-111 and 20 in the placebo subjects, and these are subjects that tested positive for SARS-CoV-2 virus and are deemed to be at high-risk for acute respiratory distress syndrome.

The primary efficacy end point will be the proportion of patients that are alive and without respiratory failure at day 29. Secondary end points will include measured improvements on the WHO disease severity scale. It's an 8-point ordinal scale, which captures the COVID-19 disease symptoms and signs, including hospitalization, to progression of pulmonary symptoms, to mechanical ventilation as well as death. The study is expected to commence in 2 weeks. We're excited about the potential for VERU-111 to treat both the viral infection and potential for -- to treat both the viral infection and the inflammatory response caused by the virus. The Phase II primary end point -- this is critical, the Phase II primary end point is being alive without respiratory distress is a clinically meaningful one.

Because of the urgent need for effective and timely therapeutics to combat COVID-19, the company has applied for significant grant funding through both the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, called BARDA, and the Defense Advanced research Projects agency of the U.S. Department of Defense, called DARPA, to expedite the clinical development of VERU-111 for COVID-19.

The coronavirus pandemic continues to paralyze the economy and threaten lives across the world. An effective drug to treat COVID-19 is still desperately needed. And this Phase II study will expeditiously determine whether VERU-111 has efficacy and safety against COVID-19. There's really no downside to conducting this small study, especially as we get the nondilutive funding. And if VERU-111 has efficacy, the upside is substantial for patients.

Veru's ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs in large markets is being substantially supported by investments from 2 commercial sources of revenue: the FC2 Internal Condom as well as PREBOOST Roman Swipes, which is a 4% benzocaine wipe for premature ejaculation. The company also expects revenues from TADFIN, which the NDA is expected to be submitted in late 2020, early 2021, which will provide additional resources to support the company's clinical development program. As you can see from the earnings release, in Q2 fiscal year 2020, we continue to have significant growth in revenue and gross profit from these commercial products.

Although Ms. Greco will cover the detailed financial result highlights in a few moments. I would like to make a few comments. We again have the pleasure of reporting robust growth in fiscal year 2020 and expect further increases of FC2 sales in both the public sector and prescription sales in the U.S. for the rest of the year. We had a $7 million -- we had $7 million in revenue from the prescription business for Q2 fiscal year 2020 compared to $2.6 million for Q2 fiscal year 2019, an increase of 168%. In fact, to give you a sense of the growth trajectory for all of fiscal year 2019, we sold 159,000 FC2 prescribed units. And for just the first quarter -- first 2 quarters of fiscal year 2020, we sold 171,891 FC2 prescribed units.

Focusing on the Veru's commercial segment, which is made up of FC2, PREBOOST Roman Swipes and drug commercialization costs, we have net revenues increase in Q2 fiscal year 2020 to $9.9 million compared to $7 million in Q2 fiscal year 2019, which is up 43%. Gross profits for Q2 fiscal year 2020 was $7.4 million compared to $4.6 million in Q2 for fiscal year 2019, which is up 61%. In fact, our gross margin climbed to 75% of net revenues from 66%.

Our operating income from this segment significantly increased to $6.2 million from $2.8 million. Net revenue for fiscal year-to-date 2020 was $20.5 million compared to fiscal year-to-date 2019 of $13.3 million. This is an increase of 54%. Our income from operations for this segment of the business was $12 million for fiscal year-to-date 2020, up from $6.2 million in fiscal year-to-date 2019, an increase of 94.6%.

As you can see, our base commercial business is doing very well. And as a stand-alone business would be quite valuable, experiencing significant growing revenue and incomes from operations. This continued revenue growth and profit and positive cash flow from this base commercial business has allowed us to substantially invest in the development of our prostate cancer clinical programs, which enhances the entire value of Veru for our shareholders.

We intend to continue this revenue growth trajectory, with not only the current growth of revenues from FC2 and PREBOOST but also from the revenues that we expect to generate from the commercialization of the company's proprietary Tadalafil and Finasteride Combination capsule for the treatment of BPH, called TADFIN. We're collecting 12-month stability data on TADFIN manufacturing batches and expect to submit the NDA by the end of 2020 to just beginning of 2021.

In the United States, we're exploring commercially launching TADFIN through telemedicine channels. As you have seen, we've had great success with our other products using this sales channel. We expect to -- revenues from TADFIN to add substantially to near-term revenues with high gross margins, to existing and growing revenues from FC2 and the PREBOOST Roman Swipes business.

I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michele?

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Michele Greco, Veru Inc. - CFO & Chief Administrative Officer [4]

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Thank you, Dr. Steiner. As Dr. Steiner indicated, we started off the year with 2 great quarters. Let's start our highlight with the second quarter results for the 3 months ended March 31, 2020.

FC2 unit sales totaled $6.9 million compared to $9.8 million in the prior year second quarter. Total net revenues were up 43% to $9.9 million from $7 million in the prior year second quarter. The company reported quarterly sales growth in its U.S. prescription business and in PREBOOST. Net revenue from the U.S. prescription business was up 168% to $7 million from $2.6 million in the prior year second quarter. Gross profit was up 61% to $7.4 million from $4.6 million in the prior year second quarter. Gross margin increased to 75% from 66% in the prior year second quarter. The increase in gross margin is driven primarily by the increase in the U.S. prescription business.

These financial results do not reflect the new tender orders that will be coming from South Africa. We previously announced that we won 75% of the South African tender, representing up to 120 million units over 3 years for the total tender. This translates to approximately 30 million units per year for our company and potentially $10.4 million in revenue per year for a total of approximately $30 million over 3 years. We expect these new orders from South Africa to ship in greater volumes during the third quarter of this fiscal year.

Operating expenses for the quarter increased by $1 million to $7.7 million compared to the prior year second quarter of $6.7 million due to the increase in research and development costs of $1 million. Nonoperating expenses were $644,000 compared to $1.9 million in the prior year second quarter and primarily consisted of interest expense and the change in the fair value of the derivatives liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018.

For the quarter, we recorded a tax benefit of $133,000 compared to a tax expense of $25,000 in the prior year second quarter. The effective tax rate for this quarter of 14% is due to recording a valuation allowance against the net operating loss generated for the quarter in the U.S. The bottom line results for the second quarter of fiscal 2020 was a net loss of $811,000 or $0.01 per diluted common share compared to a net loss of $4 million or $0.06 per diluted common share in the prior year second quarter.

Now turning to highlights of the results for the 6 months ended March 31, 2020. For the first 6 months of fiscal 2020, the FC2 unit sales totaled 17 million compared to 17.2 million units in the prior year period. Total net revenues were up 54% to $20.5 million from $13.3 million in the prior year period. The company reported growth in FC2 sales in the U.S. prescription business and in PREBOOST. Net revenue from the U.S. prescription business was up 158% to $13 million from $5 million in the prior year period.

And just to note, for all of fiscal year 2019, the U.S. prescription revenue was $14.1 million. Net revenue for PREBOOST Roman Swipes was $574,000 compared to $180,000 in the prior year period. Gross profit was up 59% to $14.7 million from $9.3 million in the prior year period. Gross margin increased to 72% from 69% in the prior year period due primarily to the increase in the U.S. prescription business.

Operating expenses increased by $4.4 to $16.8 million compared to the prior year period of $12.4 million driven primarily by the increase in research and development costs of $4 million. Nonoperating expenses were $2.2 million compared to $2.9 million in the prior year period, and primarily consisted of interest expense and the change in the fair value of the derivative liabilities related to the synthetic royalty financing.

For the 6-month period, we recorded a tax benefit of $210,000 compared to a tax expense of $118,000 in the prior year period. The effective tax rate for the 6 months of 4.9% is due to recording a valuation allowance against the net operating loss generated for the 6 months in the U.S. The company has net operating loss carryforwards for U.S. federal tax purposes of $42.7 million with $14.4 million expiring in years through 2038, and $28.3 million, which can be carried forward indefinitely. And our U.K. subsidiary has net operating loss carryforwards of $61.7 million, which do not expire.

The bottom line results for the first 6 months of fiscal 2020 was a net loss of $4.1 million or $0.06 per diluted common share compared to a net loss of $6.2 million or $0.10 per diluted common share in the prior period. The reduction in the net loss of $2.1 million is due primarily to the increase in our net revenues, which is offset by the increase in our research and development costs.

Turning to our balance sheet. As of March 31, 2020, our cash balance was $2.6 million and our accounts receivable were $5.8 million compared to a cash balance of $6.3 million and accounts receivable of $5 million at September 30, 2019. During the 6 months ended March 31, 2020, we used cash of $4.9 million for operating activities compared with using cash of $4 million in the prior period.

Overall, we're delighted to see the continued increases in sales in the U.S. FC2 prescription business and the increasing sales of PREBOOST Roman Swipes to Roman Health Ventures and look forward to increasing sales in the global public sector business in the third quarter. These revenue sources continue to be a source of funds we use to invest in our promising pharmaceutical clinical programs as we continue to transform our company into an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer.

Now I'd like to turn the call back to Dr. Steiner.

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Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [5]

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Thank you, Michele. We have enjoyed yet another strong financial quarter, which has allowed us to significantly advance our clinical programs. In fact, we now have had 10 straight quarters of growth in our FC2 U.S. prescription business. Looking forward to the rest of fiscal year 2020 and early fiscal year 2021, we expect our revenues to continue to be strong and growing towards a record year.

With the improving performance of the commercial business, we believe that we'll be able to substantially invest in the continued clinical development of our prostate cancer and other cancer drug product candidates as well as to submit the NDA and, if approved, commercially launch TADFIN to -- through Internet sales, which would provide even more revenue, adding to the already growing revenue from FC2 and from PREBOOST Roman Swipes. We are creating a very valuable commercial business, which includes both the urology specialty pharmaceuticals and the female health company divisions.

With the new clinical data from the VERU-111 prostate cancer program, we must prioritize and focus our efforts towards the execution of the Phase III registration program for this unmet need in prostate cancer. This begins by obtaining regulatory clarity from both FDA and EMA on the clinical trial design. We have reached an important company clinical milestone that well positions Veru as an oncology biopharmaceutical company.

We anticipate a steady flow of important positive news for Veru over the next few months to a year. One, for VERU-111, our oral selective antitubulin, we will report an open-label efficacy and safety clinical results from the Phase II clinical trials of VERU-111. And we will meet with the FDA and report on the Phase III clinical trial program.

For VERU-100, our novel peptide GnRH antagonist 3-month depot formulation, we will complete GMP manufacturing of clinical supply, we'll submit the IND, and we'll initiate the Phase II clinical trial. With zuclomiphene, our oral estrogen receptor agonist, we will have a face-to-face meeting with the FDA for -- face-to-face and a Phase II meeting with FDA.

We plan to initiate and complete the Phase II clinical program for COVID-19 and subjects of high-risk to acute respiratory distress syndrome. We'll submit the NDA for TADFIN. We would have secured partnerships with some of our drug products. And we plan to continue to demonstrate robust growing revenues for our commercial products FC2 and PREBOOST Roman Swipes.

We're committed to driving shareholder value by transforming Veru into an oncology company. We will initially focus our efforts to providing substantial benefits to prostate cancer patients by developing and commercializing VERU-111 as well as our other oncology products to address unmet medical needs in the management of their disease.

With that, I now open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) The first question comes from Brandon Folkes of Cantor Fitzgerald.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [2]

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Congratulations on all the progress. And on VERU-111, granted you haven't met with the regulatory agencies, could you perhaps just elaborate about how you're thinking about the Phase III design? Anything you can say maybe around the size and number of patients?

And then how are you thinking about what is the hurdle you think physicians in practice will want to see in that Phase III to use VERU-111 in practice? And then, lastly, maybe just on COVID-19. Should we think of this as a potential revenue-generating opportunity for the company? Or is this going to be similar to what we think from other companies, where it's really just a public duty-type thing?

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Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [3]

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Thank you. All excellent questions. So let's talk about the Phase III design for the -- for VERU-111. So what I can do is I can refer you to the ALAPARIB, that's A-L-A-P-R-I-B -- so A-L-A-P-A-R-I-B study that's in front of the FDA as we speak. It's very instructive in terms of how we're thinking about our clinical trial. So this is one I believe will get approved. This is a patient population that's similar to our patient population. These are patients with metastatic castration-resistant prostate cancer that have failed an androgen blocking agent. Some of them had chemo, but just some -- but mostly the same patient population.

And the reason I bring that up is because it is a registration trial, and the FDA has allowed them to use as an active comparator patients that have placed on an alternative androgen blocking agent. So that means if you think of our patient populations, they fail castration, so they're castration resistant. They put on an androgen blocking agent, either enzalutamide or abiraterone, and then they get randomized to alternative androgen blocking agent. It means if they start out with abiraterone, they get put on enzalutamide. If they start with enzalutamide, they get put on abiraterone. That's what I mean by alternative androgen blocking agent, okay?

And that's your comparator arm. The FDA has allowed that in 3 of the nonmetastatic studies that have been approved, and it's being allowed in this study. So that's why we feel pretty good. The end point of that study, just like those other 3 clinical studies were nonmetastatic, is progression-free survival, radiographic progression-free survival or imaging-based progression-free survival. Another way of saying that is when cancer progresses and you can see it on either bone scan or CT scan, that's deemed a failure, okay? They've accepted that, okay?

The active comparator, in this case, is an oral agent that's going after patients -- that ALAPARIB is going after patients that have a genetic mutation, which is really a small segment of the population. That's why we want to be the go-to drug. We want to be the drug that will treat anybody, not anybody that has a genetic mutation. So that's a much bigger market.

And the -- and in that study, interestingly, they hit -- the hurdle they have to hit is in the treatment and then back up, in terms of the trial size, because you can do progression-free survival, imaging-based progression-free survival, sort of 800 patients or 1,000 patients in the study. That study, I think, is about 250 patients. So the range is going to be around the 250 to 300 mark. It's a much smaller study. And quite frankly, it's a shorter study. And the reason it's a shorter study is because the comparator arm, the active control, fails in about 3.4 to 3.6 months. So if you go for a year, you've got 3 of those cycles. And so follow-up is not very long, unfortunately, for the patient. But your benchmark that you're going up against is about 3.4, 3.6 months median progression-free survival and radiographic progression-free survival. And for ALAPARIB, they showed a 7.4-month advantage. And everybody believes it's going to get approved, okay?

So I shared that with you because I think we're going to be very similar to that. I think our trial design -- our trial size will be between 250 and 300. I think we're going to have an end point of imaging-based progression-free survival. I think we'll be able to compare our agent VERU-111 against an alternative blocking -- alternative androgen blocking agent. I think the hurdle that we need to hit is going to be about 3.4 to 3.6 months.

I have comfort to know that in the Phase Ib, the median duration of response is 10 months, with a range between 6 and 14 months. It feels good but, of course, you have to be careful. It is Phase Ib, but that gives you comfort that we should be in good shape from the standpoint of being able to beat that. And that's the kind of design.

So it feels safe because we're not asking the agency to do something new. And -- but it also gives you a sense of why we're excited about going into a Phase III registration program because these patients are around so recruitment should be pretty straightforward. And it's completely an unmet medical need. And there's enough regulatory precedent that we can feel comfortable around trial design.

As it relates to your second question, which has to do with COVID-19. That's nice you're doing it, and you're going to do like Gilead and just kind of give it away and give all the doses to the government and show 3 or 4 days of hospital benefit and move on. Now we're a small company, and we think we have an innovative compound, VERU-111.

Excerpt from:
Edited Transcript of FHCO earnings conference call or presentation 13-May-20 12:00pm GMT - Yahoo Finance

Business partners Soyama Mthongana and Athenkosi Denga, both 26, started farming in Peddie in the Eastern Cape in 2011, but only formalised their business, Lizwe Meat, in 2015.

Growing up in Port Elizabeth, the pair learnt about farming from their fathers and grandfathers, who ran livestock. From the outset, Mthongana and Dengas goal was to build on the knowledge they had gained from their families, and find innovative ways to farm better at a commercial level.

When starting out on their own, they decided to run farms independently from their families.

Setting an exampleDenga says that one of the purposes of their business operation is to demonstrate that black South African youth can produce quality beef cattle.

We cant leave unchallenged the stigma that farming is for the older generation.

He adds that a successful livestock business requires substantial financial investment in land, labour and infrastructure, as well investing time and resources to upskill oneself. This is why he and Mthongana took up studies specifically to help them in their business operation.

Between them, they hold degrees in marketing, accounting and business administration. Denga is in the process of completing a masters degree that researches ways of improving beef sales in South Africa.

The partners farming operation is run on leased land.

Were in year four of a 10-year lease of a 600ha farm. About 400ha is suitable for grazing, Denga says.

They have a commercial beef cattle herd consisting of 88 Bonsmara, Brangus and Hereford-type animals.

The genetic traits of these breeds, such as good feed conversion, are well suited to the environment we farm in. The weaners produced by the herd perform well in the feedlot.

The South African market requires cattle that produce tender carcasses with a high meat-to-bone ratio and uniform marbling.

They have three bulls and 85 female animals and produce about 75 weaners a year. From 2015 they decided to farm only one breed, and chose the Bonsmara because of its good performance record in the feedlot industry.

They are still in the process of converting their existing mixed herd to a pure Bonsmara herd by bringing in more Bonsmara bulls.

Over the long term, they also intend acquiring more land to grow their operation further.

Grazing campsDenga and Mthongana have implemented a rotational grazing system.

Without this system, the farm will be overgrazed, and it will take a long time to recover, he says.

They have four camps, and use two for their female animals, keeping between 40 and 45 in each camp. The bulls are kept in the third camp and the fourth is left to rest.

According to Denga, the cattle should be moved on before the grass is grazed down to its roots, as this has a negative effect on regrowth.

Production systemDuring the breeding season, one bull is taken to each female animal camp and a third is alternated between the two camps, so at times there are two bulls in one camp. The bulls run with the cows/heifers for three months, and calving is in October.

At the moment, we achieve a conception rate of 90%. However, were working on this by improving the genetics of the herd, says Denga.

They implement a strict culling regime; any cow that fails to produce one calf a year is culled. The calves stay with their dams until they are weaned at seven to eight months.

Their calving rate is about 90% and their weaning rate 95%.

Calves are not weighed at birth, but at weaning; the partners aim for a weaning weight of 210kg, at which point the weaners can be marketed to feedlots.

To ensure the health of our herd, we maintain constant communication with the provincial agriculture department state veterinarian, Dr Chauke Maluleke, to find out what diseases are prevalent in the area, and we vaccinate and treat animals accordingly, says Denga.

Feedlots and auctionsIn addition to selling weaners directly to feedlots, Mthongana and Denga sell their cattle through auctions, which they organise in partnership with GWK and the National Agricultural Marketing Council (NAMC).

Auctions are not easily accessible for emerging and communal farmers because of the costs associated with them.

Transport to and from the auction for individual farmers can be prohibitively high.

This was the main reason we decided to become involved in auctions, and host them in such a way that theyd become more widely accessible, Denga says.

They conducted market research about which areas needed access to markets, and started by focusing on an area close to Mthatha in the former Transkei.

According to Denga, the livestock at auctions sells itself as people can see which animals are in good health.

These events also give farmers an opportunity to benchmark themselves against other farmers, and share information on how to improve the quality of their animals.

In addition, auctions create healthy competition between farmers and inspire them to produce better-quality livestock.

Denga adds that some older farmers are not knowledgeable about the South African red meat grading system and the market demand for tender beef from younger animals.

In our experience, many of the older farmers we deal with dont understand that this is where the industry is going, he says.

Denga says he and Mthongana hold most of their auctions close to the end of the year, when the majority of farmers want to sell their cattle to satisfy increased demand. The auctions are hosted in temporary structures set up at different venues in the rural areas.

We try to meet the farmers who participate halfway by offering them a reasonable rate to assist with transport to and from the auction venues, says Denga.

Auctions also represent a safer way for farmers to sell their cattle, as all proceeds from sales are transferred electronically, which is more secure than dealing on the informal market, says Denga.

Agriculture has great potential to contribute to South Africas economy. We believe that farming is where the countrys next generation of millionaires will come from.

Email Athenkosi Denga at [emailprotected], or Soyama Mthongana at [emailprotected].

See more here:
Two young cattle farmers bring auctions to communal areas - Farmer's Weekly

Not intended for UK-based media

- Results from two studies of BAVENCIOto be featured in ASCO press briefing

- Primary efficacy, biomarker and HRQoL analyses for tepotinib, the first MET inhibitor to have received a regulatory approval for NSCLC with METgene alterations

- Two-year follow-up for first-in-class bifunctional immunotherapy bintrafusp alfatargeting TGF-/PD-L1, in second-line NSCLC

ROCKLAND,Massachusetts, May 13, 2020 /PRNewswire/ --EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada,today announced data for its innovative investigational agents and investigational uses of marketed medicines to be presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program, to be held virtually from May 29-31.

This year, ASCO will be highlightingduring its embargoed presscast on Tuesday, May 26 and at the plenary session on Sunday, May 31the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of BAVENCIO (avelumab) in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC)*. Additional data will be presented for early- to late-stage molecules discovered and developed in-house that demonstrate the Company's commitment and relentless drive to discover, develop and deliver innovative treatment options in its hope to turn cancer patients into cancer survivors. Research from several investigator-sponsored and collaborative research studies also will be shared. This includes a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of avelumab for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), which also will be featured in the ASCO press program (Abstract# LBA6008).

"Despite the many advances in cancer treatment, we have an urgency to continue to discover and develop innovative treatment options that will have a major impact on the lives of people living with cancer,"said Luciano Rossetti, Global Head of Research & Development for EMD Serono. "Taking on this challenge, we've applied our deep knowledge of cancer biology to highly focused areas to develop the first-in-class oral MET inhibitor, tepotinib, which received the first approval anywhere in the world for the treatment of NSCLC with MET gene alterations, and our first-in-class bifunctional fusion protein immunotherapy, bintrafusp alfa, both of which have promising outcomes featured at this year's ASCO meeting."

For tepotinib, approved in Japan for the treatment of patients withunresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METexon 14 (METex14)skipping alterationsand the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval, data will be presented from the primary analysis of the VISION study with promising activity in patients with advanced EGFR/ALK wild-type, METex14 skipping NSCLC who were prospectively enrolled using liquid biopsy or tissue biopsy. Results (Abstract #9556) include6-month follow-updata for the primary endpoint of objective response rate (ORR) as determined by independent review committee. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, molecular responses, and safety data. Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575). These outcomes are the first time HRQoL have been reported for patients with METex14skipping NSCLC.

For bintrafusp alfa, a novel bifunctional fusion protein targeting TGF- and PD-L1, two-year follow-up data from a global Phase I study in second-line NSCLC will be presented (Abstract# 9558). These data continue to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression (80%). The overall safety profile has remained consistent since the interim analysis, with no new safety signals or deaths and one additional treatment-related discontinuation (blood alkaline phosphatase increased). Studies in the bintrafusp alfa lung cancer program include:

The Company's broad portfolio of investigational DNA damage response (DDR) inhibitors represents multiple development paths, including combinations with other agents and modalities. A trial-in-progress poster (Abstract #TPS4117) will review a multicenter Phase Ib/II study evaluating the safety, tolerability, pharmacokinetics and efficacy of the DNA-PK inhibitor peposertib (formerly M3814) in combination with capecitabine and radiotherapy as neoadjuvant treatment in patients with locally advanced rectal cancer.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About tepotinib

Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, including both METex14 skipping alterations and MET amplifications, or MET protein overexpression. Discovered in-house at Merck KGaA, Darmstadt, Germany, it has been designed to have a highly selective mechanism of action,7 with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.Tepotinibis currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.Merck KGaA, Darmstadt, Germany is actively assessing the potential of investigating tepotinib in combination with novel therapies and in other tumor indications. Tepotinib is approved under the brand name TEPMETKO in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations. The brand name TEPMETKO is not approved for use outside of Japan.

About bintrafusp alfa

Bintrafusp alfa (M7824), discovered in-house at Merck KGaA, Darmstadt, Germany, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF- and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses.In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

INTR@PID is the global clinical trial program investigating the potential co-localized, dual inhibition of TGF- and PD-L1 with bintrafusp alfa (M7824) in multiple tumor types. Current clinical trial information can be found on the INTR@PID website at http://www.intrapidclinicaltrials.com. To date, more than 850 patients with various types of solid tumors have been treated globally in the bintrafusp alfa INTR@PID clinical development program.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribeto register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.

EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Contacts:

Media:Julissa Viana781 206 5795

Investor Relations+49 6151 72-3321

Originally posted here:
Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020 - WFMZ Allentown

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics , Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the first quarter ended March 31, 2020.

The human tragedy of this pandemic has long tentacles that effect numerous businesses including AgeX, said Greg Bailey M.D., Chairman. Given the current global economic landscape, and the changes that businesses will need to make to accommodate to a post pandemic world, we feel that new business model aligns well to be able to function in this new environment. We see enormous opportunity to license and joint venture PureStem and HLA-G while implementing a definitive plan to begin preclinical trials on tissue regeneration under the leadership of Michael West and Michael May. We will update you in the future as these plans progress.

AgeX has completed a company restructuring to help set it up for success in the future. The combination of company priorities, cash position and the COVID-19 pandemic led to employee lay-offs designed to support the evolution of AgeX's current team to execute on strategic business goals going forward and to ensure cash is directed at near-term priorities to deliver maximum shareholder value. AgeX has a dual business strategy to diversify risk and maximize opportunities. It plans to continue to pursue its licensing and collaboration strategy for its two primary technology platforms, UniverCyte immunotolerance technology for the generation of universal cells, and PureStem cell derivation and manufacturing technology for the production of therapeutic cells with potential advantages, including industrial scalability and lower manufacturing costs. Since the launch of its licensing and collaboration strategy in January 2020, AgeX has delivered a research collaboration in Japan focused on developing universally transplantable cells for therapeutic use based on UniverCyte, entered into a neural stem cell therapy research collaboration for neurological disorders utilizing PureStem at a California University, and AgeX licensee ImStem Biotechnology received the first-ever clearance of a cell therapy derived from AgeXs embryonic stem cells by the FDA to enter human studies.

In addition, AgeX remains committed to pursuing in-house cell therapy product development and plans to raise money to build the optimal team to deliver on its products, AGEX-BAT1 for metabolic diseases such as type II diabetes and AGEX-VASC1 for tissue ischaemia. AgeXs budgetary and personnel adjustments will result in the deferral of in-house product development and may also lead to AgeX seeking arrangements with other companies in the cell therapy or biopharma industry for the development of its product candidates and technology, or outsourcing of some of that work to service providers until further funding can be obtained to rebuild in-house research and development staff for one or more of those programs. Development of AgeXs iTR technology may be done at AgeXs subsidiary Reverse Bioengineering, Inc. subject to successful financing of the subsidiary.

Upwards of 80% of healthcare expenditures in the United States relates to chronic degenerative disease and aging is a principle underlying cause of such conditions, said Michael D. West, Ph.D., AgeXs Chief Executive Officer. Therefore, the ability to manufacture to scale young clinical-grade cells capable of regenerating functionality in diverse tissues of the body has the potential to transform healthcare as we know it today. Perhaps even more noteworthy is the potential of reversing developmental aging in the body itself through AgeXs iTR technology. Our goal in the coming year is to advance the development of our intellectual property with the goal of bringing value to our shareholders.

Q1 Highlights

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. On April 1, 2020 AgeX drew the initial $500,000, and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on March 30, 2020 and May 14, 2020, respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan will bear interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the PPP to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX intends to use the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

During April 2020, AgeX initiated staff layoffs that affected 12 employees, primarily research and development personnel. AgeX has paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which are expected to be settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, and considering that loans from Juvenescence in excess of an initial $500,000 advance under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the $500,000 loan under the New Loan Agreement, the PPP Loan and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three months ended March 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

First Quarter 2020 Operating Results

Revenues: Total Revenues for the first quarter of 2020 were $515,000 as compared with $388,000 for the first quarter of 2019. AgeX revenue is primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $86,000 of allowable expenses under its research grant from the NIH as compared with $15,000 in the same period in 2019.

Operating expenses: Operating expenses reported for the three months ended March 31, 2020 were $3.7 million as compared to $3.4 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended March 31, 2020 were $3.2 million as compared to $2.8 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses increased by $0.3 million to $1.6 million during the three months ended March 31, 2020 from $1.3 million during the same period in 2019. The increase was primarily attributable to an increase of $0.2 million in scientific consultants, $0.2 million in laboratory facilities and equipment related expenses and maintenance, $0.1 million in personnel related expenses allocable to research and development, and $0.1 million in depreciation and amortization of laboratory equipment and improvements. These increases were offset to some extent by a decrease of $0.3 million in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of the Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses for the three months ended March 31, 2020 remained consistent with the same period in 2019 of $2.1 million despite bearing the full lease and facilities related costs since April 2019, and an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

March 31,

2020

December 31,

2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

468

$

2,352

Accounts and grants receivable, net

366

363

Prepaid expenses and other current assets

1,238

1,339

Total current assets

2,072

4,054

Continue reading here:
AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update - Business Wire

The report on the global Progenitor Cell Product market is comprehensively prepared with main focus on the competitive landscape, geographical growth, segmentation, and market dynamics, including drivers, restraints, and opportunities. It sheds light on key production, revenue, and consumption trends so that players could improve their sales and growth in the GlobalProgenitor Cell Product Market.It brings to light key factors affecting the growth of different segments and regions in the global Progenitor Cell Product market. It also offers SWOT, Porters Five Forces, and PESTLE analysis to thoroughly examine the global Progenitor Cell Product market.It offers a detailed analysis of the competition and leading companies of the global Progenitor Cell Product market. Here, it concentrates on the recent developments, sales, market value, production, gross margin, and other important factors of the business of top players operating in the global Progenitor Cell Product market.

Key companies operating in the global Progenitor Cell Product market include:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

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The report has classified the global Progenitor Cell Product industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Progenitor Cell Product manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Progenitor Cell Product industry.

Global Progenitor Cell Product Market Segment By Type:

, Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

Global Progenitor Cell Product Market Segment By Application:

Progenitor Cell Product

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Progenitor Cell Product industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Progenitor Cell Product market includeNeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Regions and Countries

The Middle East and Africa(GCC Countries and Egypt)North America(the United States, Mexico, and Canada)South America(Brazil etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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What is the size and CAGR of the global Progenitor Cell Product market?

Which are the leading segments of the global Progenitor Cell Product market?

What are the key driving factors of the most profitable regional market?

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Table of Contents

Table of Contents 1 Progenitor Cell Product Market Overview1.1 Progenitor Cell Product Product Overview1.2 Progenitor Cell Product Market Segment by Type1.2.1 Pancreatic progenitor cells1.2.2 Cardiac Progenitor Cells1.2.3 Intermediate progenitor cells1.2.4 Neural progenitor cells (NPCs)1.2.5 Endothelial progenitor cells (EPC)1.2.6 Others1.3 Global Progenitor Cell Product Market Size by Type1.3.1 Global Progenitor Cell Product Sales and Growth by Type1.3.2 Global Progenitor Cell Product Sales and Market Share by Type1.3.3 Global Progenitor Cell Product Revenue and Market Share by Type1.3.4 Global Progenitor Cell Product Price by Type1.4 North America Progenitor Cell Product by Type1.5 Europe Progenitor Cell Product by Type1.6 South America Progenitor Cell Product by Type1.7 Middle East and Africa Progenitor Cell Product by Type 2 Global Progenitor Cell Product Market Competition by Company2.1 Global Progenitor Cell Product Sales and Market Share by Company (2014-2019)2.2 Global Progenitor Cell Product Revenue and Share by Company (2014-2019)2.3 Global Progenitor Cell Product Price by Company (2014-2019)2.4 Global Top Players Progenitor Cell Product Manufacturing Base Distribution, Sales Area, Product Types2.5 Progenitor Cell Product Market Competitive Situation and Trends2.5.1 Progenitor Cell Product Market Concentration Rate2.5.2 Global Progenitor Cell Product Market Share of Top 5 and Top 10 Players2.5.3 Mergers & Acquisitions, Expansion 3 Progenitor Cell Product Company Profiles and Sales Data3.1 NeuroNova AB3.1.1 Company Basic Information, Manufacturing Base and Competitors3.1.2 Progenitor Cell Product Product Category, Application and Specification3.1.3 NeuroNova AB Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.1.4 Main Business Overview3.2 StemCells3.2.1 Company Basic Information, Manufacturing Base and Competitors3.2.2 Progenitor Cell Product Product Category, Application and Specification3.2.3 StemCells Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.2.4 Main Business Overview3.3 ReNeuron Limited3.3.1 Company Basic Information, Manufacturing Base and Competitors3.3.2 Progenitor Cell Product Product Category, Application and Specification3.3.3 ReNeuron Limited Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.3.4 Main Business Overview3.4 Asterias Biotherapeutics3.4.1 Company Basic Information, Manufacturing Base and Competitors3.4.2 Progenitor Cell Product Product Category, Application and Specification3.4.3 Asterias Biotherapeutics Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.4.4 Main Business Overview3.5 Thermo Fisher Scientific3.5.1 Company Basic Information, Manufacturing Base and Competitors3.5.2 Progenitor Cell Product Product Category, Application and Specification3.5.3 Thermo Fisher Scientific Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.5.4 Main Business Overview3.6 STEMCELL Technologies3.6.1 Company Basic Information, Manufacturing Base and Competitors3.6.2 Progenitor Cell Product Product Category, Application and Specification3.6.3 STEMCELL Technologies Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.6.4 Main Business Overview3.7 Axol Bio3.7.1 Company Basic Information, Manufacturing Base and Competitors3.7.2 Progenitor Cell Product Product Category, Application and Specification3.7.3 Axol Bio Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.7.4 Main Business Overview3.8 R&D Systems3.8.1 Company Basic Information, Manufacturing Base and Competitors3.8.2 Progenitor Cell Product Product Category, Application and Specification3.8.3 R&D Systems Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.8.4 Main Business Overview3.9 Lonza3.9.1 Company Basic Information, Manufacturing Base and Competitors3.9.2 Progenitor Cell Product Product Category, Application and Specification3.9.3 Lonza Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.9.4 Main Business Overview3.10 ATCC3.10.1 Company Basic Information, Manufacturing Base and Competitors3.10.2 Progenitor Cell Product Product Category, Application and Specification3.10.3 ATCC Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.10.4 Main Business Overview3.11 Irvine Scientific3.12 CDI 4 Progenitor Cell Product Market Status and Outlook by Regions4.1 Global Progenitor Cell Product Market Status and Outlook by Regions4.1.1 Global Progenitor Cell Product Market Size and CAGR by Regions4.1.2 North America4.1.3 Europe4.1.4 Asia-Pacific4.1.5 South America4.1.6 Middle East and Africa4.2 Global Progenitor Cell Product Sales and Revenue by Regions4.2.1 Global Progenitor Cell Product Sales Market Share by Regions (2014-2019)4.2.2 Global Progenitor Cell Product Revenue Market Share by Regions (2014-2019)4.2.3 Global Progenitor Cell Product Sales, Revenue, Price and Gross Margin (2014-2019)4.3 North America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.3.1 North America Progenitor Cell Product Sales by Countries4.3.2 United States4.3.3 Canada4.3.4 Mexico4.4 Europe Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.4.1 Europe Progenitor Cell Product Sales by Countries4.4.2 Germany4.4.3 France4.4.4 UK4.4.5 Italy4.4.6 Russia4.5 Asia-Pacific Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.5.1 Asia-Pacific Progenitor Cell Product Sales by Regions4.5.2 China4.5.3 Japan4.5.4 South Korea4.5.5 India4.5.6 Australia4.5.7 Indonesia4.5.8 Thailand4.5.9 Malaysia4.5.10 Philippines4.5.11 Vietnam4.6 South America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.6.1 South America Progenitor Cell Product Sales by Countries4.6.2 Brazil4.7 Middle East and Africa Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.7.1 Middle East and Africa Progenitor Cell Product Sales by Countries4.7.2 Turkey4.7.3 GCC Countries4.7.4 Egypt4.7.5 South Africa 5 Progenitor Cell Product Application5.1 Progenitor Cell Product Segment by Application5.1.1 Medical care5.1.2 Hospital5.1.3 Laboratory5.2 Global Progenitor Cell Product Product Segment by Application5.2.1 Global Progenitor Cell Product Sales by Application5.2.2 Global Progenitor Cell Product Sales and Market Share by Application (2014-2019)5.3 North America Progenitor Cell Product by Application5.4 Europe Progenitor Cell Product by Application5.5 Asia-Pacific Progenitor Cell Product by Application5.6 South America Progenitor Cell Product by Application5.7 Middle East and Africa Progenitor Cell Product by Application 6 Global Progenitor Cell Product Market Forecast6.1 Global Progenitor Cell Product Sales, Revenue Forecast (2019-2025)6.1.1 Global Progenitor Cell Product Sales and Growth Rate Forecast (2019-2025)6.1.2 Global Progenitor Cell Product Revenue and Growth Rate Forecast (2019-2025)6.2 Global Progenitor Cell Product Forecast by Regions6.2.1 North America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.2 Europe Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.3 Asia-Pacific Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.4 South America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.5 Middle East and Africa Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.3 Progenitor Cell Product Forecast by Type6.3.1 Global Progenitor Cell Product Sales and Revenue Forecast by Type (2019-2025)6.3.2 Pancreatic progenitor cells Growth Forecast6.3.3 Cardiac Progenitor Cells Growth Forecast6.4 Progenitor Cell Product Forecast by Application6.4.1 Global Progenitor Cell Product Sales Forecast by Application (2019-2025)6.4.2 Global Progenitor Cell Product Forecast in Medical care6.4.3 Global Progenitor Cell Product Forecast in Hospital 7 Progenitor Cell Product Upstream Raw Materials7.1 Progenitor Cell Product Key Raw Materials7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price7.1.3 Raw Materials Key Suppliers7.2 Manufacturing Cost Structure7.2.1 Raw Materials7.2.2 Labor Cost7.2.3 Manufacturing Expenses7.3 Progenitor Cell Product Industrial Chain Analysis 8 Marketing Strategy Analysis, Distributors8.1 Sales Channel8.2 Distributors8.3 Downstream Customers 9 Research Findings and Conclusion 10 Appendix10.1 Methodology/Research Approach10.1.1 Research Programs/Design10.1.2 Market Size Estimation10.1.3 Market Breakdown and Data Triangulation10.2 Data Source10.2.1 Secondary Sources10.2.2 Primary Sources10.3 Author List10.4 Disclaimer

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The coronavirus, as we all know, has brought our economy to its knees. As the search for vaccines and treatments accelerates, geneticists are now looking to our genes to understand why some recover quickly or show no symptoms, while others die. To do so, they are searching DNA databases and cross-referencing them with COVID-19 cases. This research holds great promise for addressing the pandemic.

Yet if scientists do find answers in our genes, we need to consider the implications for genetic privacy. Armed with the ability to identify who is vulnerable and who is not, how will society proceed?

On the one hand, health care providers could use genetic testing to help vulnerable patients stay safe. But there would also be a temptation to use genetic testing in the workplace. Companies could use genetic test results to manage the risks for all employees, for example by controlling the activities of those who are most vulnerable. Businesses will also see opportunities to use genetic test results in the marketplace, for example by tailoring insurance offerings according to genetic risk. Currently, there are some limited legal protections against genetic discrimination and health privacy intrusions, but the pandemic has already led the federal government toscale backsome of those protections for the time being.

Although the rationale for expanded genetic testing is obviously meant for the greater good, such testing could also bring with it a host of privacy and economic harms. In the past, genetic testing has also been associated with employment discrimination. Even before the current crisis, companies like 23andMe and Ancestry assembled and started operating their own private long-term large-scale databases of U.S. citizens genetic and health data. 23andMe and Ancestry recently announced they would use their databases to identify genetic factors that predict COVID-19 susceptibility.

Other companies are growing similar databases, for a range of purposes. And the NIHs AllofUs program is constructing a genetic database, owned by the federal government, in which data from one million people will be used to study various diseases. These new developments indicate an urgent need for appropriate genetic data governance.

Leaders from the biomedical research community recently proposed a voluntary code of conduct for organizations constructing and sharing genetic databases. We believe that the public has a right to understand the risks of genetic databases and a right to have a say in how those databases will be governed. To ascertain public expectations about genetic data governance, we surveyed over two thousand (n=2,020) individuals who altogether are representative of the general U.S. population. After educating respondents about the key benefits and risks associated with DNA databasesusing information from recent mainstream news reportswe asked how willing they would be to provide their DNA data for such a database.

The results were surprising. Initially, we believed people would generally approve of donating their genetic data for altruistic reasons, such as for example, finding a vaccine for COVID-19, so we assumed they would be more willing to provide their data to a hospital or university compared with a tech company or pharmaceutical firm. But we found a fairly similar level of willingnessregardless of who owns the database. While 37 percent were unwilling to provide their DNA data to a technology company (like 23andMe), about the same percent were unwilling to provide it to a hospital (40 percent), a government health institute (37 percent), a pharmaceutical firm (40 percent) or a university (35 percent).

The most important thing our survey revealed was that the willingness of individuals to provide their genetic data depended greatly on the kinds of policies that would govern that data. Thus, in order to find a vaccine for COVID-19, we must have genetic data governance policies that inspire confidence and that will prompt the public to donate their genetic data. Willingness to provide genetic data increased the most when people were told they would have the ability to control how their stored data is reused or shared in the future. This willingness also increased when people were assured they could have their data deleted at any point.

Conversely, one of the policies that reduced willingness to contribute the most was the retention of data indefinitely without a specified date for destruction. These patterns held equally among people who were willing to provide their data as an altruistic donation and people who were only willing to provide their data in exchange for payment of some kind. The patterns also held regardless of the type of organization the respondent was being asked about, that is whether tech company, hospital, government, pharmaceutical firm or university.

Not surprisingly, we also found that willingness to provide genetic data increased greatly when contributors knew that the organization would be using state-of-the-art cybersecurity to protect their data.

Together, these findings indicate two principles to guide needed regulation and any code of conduct for genetic databases.

The first is personal agency and control. People want to know that they can control the end uses of their DNA data. This principle puts the burden on database owners to obtain additional permissions when they want to reuse or share data. It also means designing databases so each entry has an expiration date and can be selectively removed. Technologies exist to support this principle, and some organizations are using them.

The second is equal treatment of all organizations. The same rules should apply regardless of an organizations sector (e.g., for-profit, nonprofit, government); industry (health care, technology, consumer/lifestyle and so on); or size. Such distinctions make little sense in an era when data are routinely moved, shared and reused across organizations, sectors and industriesoftenwithout the full understanding of the peopleincluded in the data.

How can these principles be integrated with existing law and regulation? One approach would be to treat genetic sequence data as personal health information under HIPAA. This is consistent with the current understanding that genetic data can neither be truly de-identified nor completely stripped of sensitive informational content. Organizational policies for data access and cybersecurity can then follow health sector guidelines at a minimum.

Naturally, when biomedical researchers think about rules for genetic information databases, they want to avoid excessive limits on using the data. After all, such limits may slow scientific progress and reduce the societal benefits of the databases. But as suggested by the recent consumer genetics slowdown, without appropriate rules in place, the public may become wary of participating. Thus, it is imperative to consider public opinion of genetic data collection, the safeguarding of the data, and the use of DNA databases.

Our research suggestsour proposed principles for genetic database governance will help preserve the publics willingness to contribute their genetic informationwhich may be our only hope of defeating the coronavirus.

The authors are co-principal investigators on a grant by the Robert Wood Johnson Foundation to research the governance of genetic testing as part of corporate wellness programs. Their article Evolving public views on the value of ones DNA and expectations for genomic database governance: Results from a national survey, co-authored with Allison Gaddis and Jennifer McCormick, was published by PLOS ONE.

Read more about the coronavirus outbreak from Scientific American here, and read coverage from our international network of magazines here.

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The Answer to a COVID-19 Vaccine May Lie in Our Genes, But ... - Scientific American