Archive for January, 2020

Unusually, the agreement means that both companies could be set for a windfall due to the structure of the co-development and co-commercialization partnership.

Adaptimmune Therapeutics could receive a total payment of $897m (806m) for its part in the deal, which includes an upfront payment of $50m, $7.5m per year for research and the rest locked away in milestone payments.

Astellas has the opportunity to make back some of this down payment, but only if Adaptimmune takes forward a drug candidate that the former company opts against developing at which point, Astellas could receive up to $552.5m in milestone payments.

The two companies are targeting the development of stem-cell derived allogeneic T-cell therapies to patients with cancer, potentially developing up to three targets. In particular, Adaptimmune will utilize its target identification and validate capabilities to generate target-specific T-cell receptors (TCRs), chimeric antigen receptors (CARs), and HLA-independent TCRS.

Astellas will contribute its donor cell and gene editing platform that it acquired through its buyout of Universal Cells. In addition, the Japanese drugmaker will provide the funds for research up until completion of a Phase I trial for each candidate.

After which point, both companies will have the option to progress with co-development and co-commercialization of the candidate, or to allow independent development of the candidate.

Astellas will also reserve the right to develop two targets independently.

Helen Tayton-Martin, chief business officer at Adaptimmune, spoke to us about the potential benefit of developing allogeneic treatments.

She explained, The first single advantage is that the products are already available frozen, and can be available almost immediately to be thawed and administered when they need them, rather than going through the cycle of apheresis, product production, shipping and re-infusion.

A second advantage is the greater consistency of the products we will manufacture, as [theyre] not dependent on individual patient cells, Tayton-Martin added.

When asked about the problems current commercial CAR-T treatments have faced in meeting specification, Tayton-Martin stated that she is confident that the companys integrated manufacturing capability will not face similar challenges to products already on the market.

Regardless of how far the potential product candidates progress, Tayton-Martin confirmed that the company now has the capital to fund it through to Q1 2021.

For Astellas, the deal marks another effort to develop its rapidly growing pipeline of potential advanced therapeutic candidates. The deal prior to this came only last week, in the form of a $665m deal for CAR-T specialist Xyphos.

Last year saw similar activity for Astellas, with a $3bn deal for gene therapy specialist Audentes announced as the year came to a close, adding on previous smaller deals to build its portfolio in the cell and gene space.

More:
Astellas and Adaptimmune partner on T-cell therapies - BioPharma-Reporter.com

The ball has dropped on a new year and a new decade, as we move from the 2010s into the 2020s. The last 10 years have seen incredible advances in science and technology, including a dramatic reduction in the cost of genetic sequencing, the first successful uses of gene therapy in humans, and the existence of gravitational waves. But what about thenextdecade? What previously impossible things will humans achieve? TheWyss Institute for Biologically Inspired Engineering at Harvard Universityasked its faculty members across a wide range of scientific disciplines what they predict will be the most impactful developments in their fields between now and the year 2030.

George Church Synthetic Biology

By 2030, we hopefully will see human clinical trials being run on transplanted organs from highly edited pigs and proteins from recoded genomes. Whole-genome sequencing may become a high-quality, equitably priced alternative to expensive gene therapies for rare diseases. Imaging will move in for close-ups (5 nm resolution) and every pixel will tell its story (DNA, RNA, protein, and lineage). Finally, we hope to see synthetic biology impact carbon sequestration via virus-resistant plants and algae, and cold-resistant elephants reverting arctic ecosystems to highly photosynthetic grasslands.

Jim Collins Synthetic Biology

Synthetic biology is well-positioned to help advance medicine over the next decade via the development of next-generation diagnostics and gene and cell therapies. The field also has tremendous potential to enhance basic research in molecular biology, by enabling the creation of novel tools to probe and analyze the complex functions of biomolecular components and systems in living cells.

Mike Levin Developmental Biology

The biggest knowledge gap, and frontier of opportunity, is taming the biological software that underlies embryogenesis and regeneration. Understanding the bioelectricity, biomechanics, and transcriptional circuits that allow cells to cooperate toward large-scale goals is the key to regenerative medicine, birth defects, cancer reprogramming, aging, synthetic bioengineering, and even new AI. Being able to exploit the decision-making, memory, and intelligence of cell swarms will result in transformative applications at the intersections of deep ideas in cognitive science, cybernetics, developmental biology, and computer science.

I anticipate the development of genetic and synthetic technologies to combat climate change and, concurrent with those developments, global discussions at all levels regarding their safe, equitable, and effective application.

Ting Wu, Synthetic Biology

Pam Silver Synthetic Biology

The engineering of biology will play a key role in the ability of the earth to support 10 billion people by implementing safe, faster, and more predictable biological systems. To feed the world and mitigate climate change, advances in synthetic biology will include increased utilization of sunlight together with mitigation of environmental contamination. The ability to respond quickly to epidemics and design better therapies will be a key advance for the field. And, as we move the needle on solving the problems on Earth, synthetic biology will also play a role in enabling and implementing the future of space exploration.

Eugene Goldfield Therapeutic Robotics

Therapeutic robotic systems in the next 10 years will no longer be considered robots. Their parts and control systems will be molecularly based, and will have capabilities akin to an immune system. The boundary between living and synthetic will continue to blur over future decades, requiring even greater care in the domain of ethics.

Don Ingber Bioinspired Therapeutics and Diagnostics

The most exciting developments in the field of bioinspired therapeutics and diagnostics will be a new paradigm for drug development that combines several unique innovations into a system that is faster, cheaper, and reduces harm to animals and humans in preclinical and clinical trials. I am especially excited about our increasing ability to analyze clinically relevant human physiological and pathophysiological responsesin vitro; high-throughput, phenotype-based screening of model organisms; novel molecular dynamics simulation capabilities; and the expanding application of deep learning technologies to solving specific clinical problems.

Samir Mitragotri Drug Delivery

The next decade in drug delivery will highlight the role of cells as drugs and carriers. Unlike drugs of the past, cells are unique in that they are living entities and have the ability to navigate through the body and reach destinations that most traditional drugs cannot. Strategies to deliver these living therapeutics will require novel approaches, and will create opportunities to use cells as carriers for targeting drugs to hard-to-reach tissues. Of particular interest are drugs that exploit or control the immune system for the treatment of cancer, autoimmune diseases, and allergies, among others. Strategies based on immune cells and immunological intervention will play a major role in drug delivery research and technology in the next 10 years.

David Walt Diagnostics

In the next 10 years, we will begin to realize the promised rewards of personalized medicine and personalized health, moving toward a system where we monitor individuals for key biomarkers and compare those results to their own measurements at an earlier time, rather than relying on population averages that dont reflect the wide biological variations that exist between people.

Dave Mooney Immunomaterials

I expect the next 10 years will lead to the demonstration, in human patients, that immunomaterials can dramatically alter the progression of various diseases. Immunomaterials will allow physicians to concentrate immune cells where they are needed in the body, regulate their activity, and disperse them when their job is done. The materials themselves will dissolve and degrade to leave nothing foreign in the body after treatment, but will create an immune memory that prevents the return of the disease.

William Shih Molecular Robotics

A major ongoing development in biomolecular science is encoding large numbers of single-molecule measurements into DNA records that can be read out later using high-throughput DNA sequencing. However, even future sequencing technologies will lack the bandwidth for sampling more than a small fraction of these records. Molecular robots built out of DNA, on the other hand, will be able to count and classify large sets of DNA records, and then summarize the results into brief DNA reports that can then be read out by DNA sequencing or other means. Thus, molecular robots will greatly increase the effective bandwidth of DNA-recording applications.

Dave Weitz Materials Science

I think that materials-by-design will become closer to a reality. We will learn how to formulate new structures on many different-length scales using a variety of fabrication methods complemented by computer-assisted design and assembly. And both the structure and functionality of the materials will be determined and controlled it will be the equivalent of precision medicine, but for materials design and synthesis.

Lou Awad Rehabilitative Medicine

To date, very few medical interventions have been designed to completely restore the pre-injury movement patterns of patients with neuromotor injury the current rehabilitation paradigm aims to rapidly attain independent walking, but patients often become independent by compensating for their injury rather than fully recovering the fast, economical, and stable gait of healthy human walking. The last decade has seen such remarkable advances in movement diagnostics,neurostimulationinterventions, and wearable robotics that the next decade is poised toachieve true restoration rather than mere compensation.

I predict that major advances in assembling cells and tissues will emerge that will allow us to print living organs for clinical use.

Chris Chen, 3D Organ Engineering

Elliot Chaikof Regenerative Medicine

Regenerative medicine employs repair, reconstruction, and replacement as strategies to treat patients with a diseased or damaged organ or tissue. Over the next decade, our capacity to repair may be dramatically enhanced through the discovery of agents that reverse the epigenetic clock, or eliminate or rejuvenate senescent cells. Reconstructive surgery will benefit from genetically reengineered off-the-shelf universal donor cells and engineered whole organs that can be used for any patient. Finally, I believe that the barrier for tissue replacement will be breached through the use of human-pig chimeras, initially to generate universally compatible human red blood cells for transfusions and, subsequently, whole organs for transplantation.

Kit Parker 3D Organ Engineering

As we start implanting organs into animals, and eventually patients, one of the most important things we will realize is the knowledge gaps we have in basic anatomy and physiology. All that we know about the functional anatomy of organs might not be enough to sufficiently mimic what we think is Natures anatomy and, unfortunately, there are hardly any classically trained anatomists or physiologists in the world anymore. To successfully engineer implantable organs, we need to develop the scientific talent to do the old-school physiology experiments that havent been done in 50 years or more to understand what we are building or need to build.

The rest is here:
Harvard Wyss researchers on the next decade in... - ScienceBlog.com

Editors Note: Endpoints News is reporting live from #JPM20 after kicking things off with an action-packed event, which you can replay here. What follows is a stream of tidbits we have collected while wandering around Union Square in San Francisco. Check back in throughout the week for updates by John Carroll and Jason Mast.

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SAN FRANCISCO A year ago Takeda CEO Christophe Weber and R&D chief Andy Plump arrived at JP Morgan right on the heels of closing their big Shire buyout. Now theyre back after shaking up the portfolio, boosting R&D spending by about 50% to $4.5 billion and adjusting the pipeline a task which isnt quite finished yet.

In an interview on Tuesday, Plump told me that Takeda is preparing the latest in a long string of spinouts after setting aside a package of psych drugs that would be better suited to the hands of some specialists. Like a lot of the major R&D outfits, its not one of their core fields of expertise.

These Takeda drugs including therapies for depression and schizophrenia are very interesting but still difficult, involving 3 clinical-stage programs and a handful of preclinical efforts, which Plump is quick to concede offer plenty of challenges to developers.

Spinouts are something that Takeda is good at. Theyve been doing these deals for several years now in the US, Europe and Asia creating up to 25 companies where they typically hand off drugs to entrepreneurs and retain a chunk of equity of around 25% to 30% of the biotech involved.

Their decisions on what to keep and what to deal out, adds Plump and Weber, have nothing to do with projected revenue.

The key aspect is innovation, says Weber. Are they innovative therapies? And its not because you shouldnt do it on projected revenue so much as you cant do it that way.

You cant do it on NPV, adds Plump, because then NPV becomes the driver of the decision and the NPV is always wrong.

The two Takeda execs spent considerable time and effort in revamping Takeda into a global, top 15 player with scale.

We were lacking scale to sustain our R&D investment, says the CEO. The Shire buyout gave us scale that allows us to compete with anyone. John Carroll

#JPM20: Catalent CEO John Chiminski isnt going anywhere important without his lucky boots

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In my one-on-one with Catalent CEO John Chiminski I was drawn to the cowboy boots he was wearing not exactly the kind of standard Brooks Brothers attire you often see at JP Morgan and asked him how many miles he had put on the boots as he traveled the world managing a global CDMO.

Heres part of the response, and its priceless:

In advance of the IPOour owners, Blackstone, went to the investment bankers and they said, Hey, before Chiminski goes out on the road show, hes got to shave his beard and he cant wear the boots. So I told the investors and I would just say, I used a couple of hand gestures and I said, look, you might as well shave my head, because Ill have about that much confidence. And I will tell you right now, if I didnt show up with my boots, which is a little harder nowadays cause Ive got arthritic hips, if I didnt show up with my boots, Id had some investors that are selling. So these boots have about a million miles and 165 million shares of Catalent were sold with these babies

Boots arent going anywhere guys. John Carroll

#JPM20: Considered New Pfizer yet? The CEO says hes whipping it into shape and getting more focused in R&D

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SAN FRANCISCO Albert Bourla isnt a fan of the Old Pfizer. Or of the analysts who are ignoring the New Pfizer.

Bourla, giving his second JP Morgan presentation as Pfizer CEO after over 25 years at the US drug-making giant, continued the rebrand he had been tapped to lead: Positioning Pfizer as a company that had been bloated for years but was now set for a streamlined future.

Phase II success rates the industry is at 30%. Pfizer for many years was at 15%, Bourla told JP Morgan analyst Christopher Scott on stage. We were taking an approach of very little rigor.

Bourla said Pfizer would further pare down on non-R&D expenses, continuing a trend they began by spinning off their Upjohn division and combining their consumer health business into a joint venture with GlaxoSmithKline. The GSK venture will move to an IPO within 3 or 4 years, he said, echoing previous comments from the British pharma.

Within research, Bourla said, they would focus on 6 areas, rather than the 12 they had long developed. Asked which parts of the pipeline were exciting but overlooked, Bourla dove for a minute through the R&D assets he thought Wall Street had ignored, including their vaccines, gene therapies, and inflammation drugs.

We do have five different JAKS that we are starting in more than 10 different indications, and only one of them I have seen minor projections for, he said. I can go on and on.

Bourla said they would focus on licensing small add-ons to the pipeline in those 6 areas and wouldnt move toward a larger merger or acquisition. It was a discouraging comment for a JP Morgan crowd watching for the next major deal, but also one Pfizer has made in the past months before acquiring Array in an $11.4 billion deal.

We never say never, Bourla said. Jason Mast

#JPM20: Consummate dealmaker Vivek Ramaswamy bags a record regional upfront in latest deal this time focused on Japan

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SAN FRANCISCO At the start of my panel on dealmaking on Monday I joked that consummate negotiator Vivek Ramaswamy was probably making a deal as we spoke, texting terms on the mobile.

Today he tells me I wasnt far off the mark. A deal was cooking right off stage.

On Day Three of JP Morgan Ramaswamy has completed what his team is calling the largest ever regional licensing deal for a derm product prior to Phase III data and one of the largest upfront payments ever for a Japanese licensing deal prior to Phase III data across any indication.

And this one was signed late Tuesday night after they put the finishing touches to the contract.

I almost laughed when you said that, Ramaswamy tells me about the panel comment. If I had not put my phone on flight mode that would have been true.

His dermatology play Dermavant has licensed out exclusive rights to develop, register and market tapinarof in Japan to Japan Tobacco, which is passing on the license to its subsidiary, Torii Pharmaceutical. The Japanese company is paying $60 million and up to $53 million in development milestones for tapinarof, in development for psoriasis and atopic dermatitis.

Dermavant CEO Todd Zavodnick is clearly stoked about the numbers for his drug, and the shot of working on this with JTs company.

Its not just a licensing deal, he says, its the right partner.

Ramaswamy bought the drug from GSK for up to $324 million. The pharma giant had been revamping its pipeline as R&D chief Hal Barron took aim at a comeback. The nonsteroidal anti-inflammatory topical cream which activates the aryl hydrocarbon receptor hasnt been a high-profile agent. But researchers have highlighted promising mid-stage data to underscore its potential. Now its in Phase III for psoriasis, with plans to tee up atopic dermatitis.

Not surprisingly, any mention of AD immediately spark comparisons to the marketing juggernaut Regeneron and Sanofi have created for Dupixent. But Dermavants drug is a topical, and Zavodnick says that in AD, patients typically get an injectable and a topical. So he believes that patients will start with the topical and then move to the combination, leaving plenty of room for his drug in the market.

Ramaswamy also notes that its rare to see two significant dermatology deals at one JP Morgan. Eli Lilly got the party started with their $1.1 billion Dermira buyout, which gave them lebrikizumab. Dermavants deal makes for a nice book end to that package of news.

Says Ramaswamy: Dermatology is back. John Carroll

#JPM20 Two biotech legends talk about gene therapys past and future

SAN FRANCISCO I had a chance on Tuesday to moderate a discussion on gene therapy R&D at the huge WuXi conference at the Hilton with Fraziers Tachi Yamada ex-CSO at GSK and Takeda and James Wilson from Penn, two big figures in the field who started a new biotech a little under a year ago to focus on monogenic diseases of the CNS. I did a bow to both of them for everything theyve pioneered in the last 2 decades, which spurred Yamada to give Wilson credit for the science work. As for Wilson, he got the biggest response from the audience with a remark that Tachi is always just called by his first name, making him the Beyonce of biotech. John Carroll

#JPM20: Biogen CEO Michel Vounatsos offers a smile of confidence as he presents aducanamab

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SAN FRANCISCO Biogen isnt softening its rhetoric.

Two months after research chief Al Sandrock all-but dared the FDA not to approve its Alzheimers drug, CEO Michel Vounatsos told an overflowing ballroom at JP Morgan that the success of a drug that operates like aducanumab is a dream.

Some of you were at CTAD and saw the data, Vountsos said, referring to the controversial subgroup analysis they presented their aducanumab trial at the Clinical Trials for Alzheimers Disease conference. Who in the room doesnt know someone who has been demented?

That analysis, coming months after the company first announced the drug had failed, relied on believing how late changes called protocol amendments to one of two identical trials made one succeed and the other fail.

Without all the protocol amendments, I would not be here, today, standing with a smile of confidence on the way forward, Vounatsos said, not quite smiling.

Still, Biogen has heard the criticism from investors, most notably Bairds Brian Skorney, that their big ambitions have left them with few assets in their pipeline likely to raise revenue soon. Vounatsos walked through the other parts of their pipeline, including a lupus drug, an ALS drug, a new MS drug and, of course, another new Alzheimers drug with a different approach: Tau. Jason Mast

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#JPM20: Gilead launches new T cell engineering player with help from familiar players at Vida and Westlake

SAN FRANCISCO After making its mark in cancer cell therapies with the Kite buyout, Gilead has allied itself with a pair of venture investors to hunt for new therapies that can address the flip side of that therapeutic coin. And theyre chipping into the launch round while adding more cash and milestones for a research collaboration to get things underway.

The new biotech theyre showing off around JP Morgan this week is Kyverna Therapeutics, which is being gifted with some cutting-edge T cell engineering tech as well as a $25 million Series A to fund work on the discovery of new drugs for autoimmune disease braking the immune system instead of organizing an attack. Gilead signed off on a collaboration that starts with a $17.5 million upfront and a full slate of research and commercial milestones that can go up to $570 million.

The startup brings together some high-profile figures and technology.

Dominic Borie, a Genentech vet and the former head of external research for Horizon Therapeutics, is heading the new venture as CEO. While at Stanford, Borie was credited with playing a part in validating JAK inhibition for rheumatoid arthritis a breakthrough tech that a bevy of drug developers would like to leapfrog with new and better drugs. Jeffrey Greve, formerly at Delinia ahead of their Celgene buyout, is CSO.

Theyre being backed by Fred Cohen at Vida Ventures and Beth Seidenberg, who founded Westlake Village BioPartners in LA after jumping from Kleiner Perkins, where she specialized in biotech for years. Cohen kickstarted Vida along with a group of experienced venture players, with a big role for Arie Belldegrun, who sold Kite to Gilead and retains some A list contacts at the big biotech.

The upstart will be using synNotch technology from Kite, which picked it up in Gileads acquisition of Wendell Lims Cell Design Labs a couple of years ago, which Belldegrun had backed as well, sitting on the board with Seidenberg.

These are the relationships that breed trust and companies. John Carroll

#JPM20: BioMarin chief Bienaime is building a gene therapy pipeline, and the manufacturing needed to control markets

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SAN FRANCISCO JJ Bienaimand his team arent just running as fast as possible to stay in the lead in the race to the first marketing OK for a gene therapy for hemophilia A. Theyre building a pipeline, and the manufacturing capacity needed to dominate their markets.

In a chat just ahead of the firing gun at JP Morgan, the BioMarin CEO told me that the biotech had obtained official sanctions in the US and UK to launch a Phase I/II study of BMN 307 this quarter for phenylketonuria (PKU). Now they will set out to see if a single dose of their gene therapy can restore natural Phe metabolism, normalize plasma Phe levels and enable a normal diet in patients with PKU.

Next up in the gene therapy portfolio, he tells me, is HAE.

Whats more, he adds, BioMarin has completed work at a facility in Novato that doubles their gene therapy capacity jumping from 5,000 to 10,000 patients a year. That could handle the hemophilia A market and the rest of the markets to come for some time. It also gets them around the bottleneck of gene therapy production that has been holding back some of the new players in the field.

Its not our intent to turn into a pure gene therapy company, but it will play an important role in BioMarin, says Bienaim.

For now, the story around gene therapy at BioMarin is centered on a simple theme: BioMarin has the first shot at an upcoming approval in hemophilia A, but a waning level of response leaves a few analysts wondering whether Sangamo, in particular, can catch up with a better therapy. The reasoning is built around the assumption that patients would prefer to wait for a better gene therapy, as they can only be dosed with an AAV product once.

Bienaim, though, doesnt believe thats true. He points to new work on next-gen gene therapies skirting AAV that can be repeatedly dosed, and that opens the door to a re-up down the road if their product stops working. Patients will take a prospective cure, he says, with a 4-year update coming up that he believes will show a continued protection against bleeds.

One other point: The CEO believes that given the high cost of treating hemophilia patients now, payers will accept a drug that costs $2 million to $3 million. (Not that that is the price they expect to charge. That decision comes later.)

But will they want some assurances that it will work long enough to make it less expensive in the long run? John Carroll

#JPM20: Vertex lays out post-CF ambitions as Gilead demurs on acquisition

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SAN FRANCISCO Vertex laid out a vision for a post-CF and a post-Jeffrey Leiden future at their investor presentation Monday morning. It looks a lot like the past.

That future, the outgoing CEO Leiden said, will center on other fields like cystic fibrosis: Specific niches where few life-altering drugs exist, including sickle cell and a rare lung disease. Those are also fields where Vertex could stand to charge the high prices theyre becoming known for.

You will never see a me-too drug from us, Leiden said, a day after Alexis Borisy sparked widespread buzz with a new biotech aimed at lowering drug prices through me-too drugs. We think transformative medicines are of the highest value for patients.

This year was all but destined to mark a new chapter for Vertex. Nearly 20 years after starting their CF program, the company introduced their capstone last year in Trikafta, a drug that covers 90% of patients. Leiden celebrated the news by leaving the CEO spot to become executive chairman.

Leiden may or may not have been referring to Borisys startups with his comments, but the reference is fitting. Vertexs drugs have made cystic fibrosis a livable disease, but it comes at a price tag over $300,000 for Trikafta payers like the NHS have balked at.

With the Vertex changes and Gilead sitting on both a wealth of cash and a shaky pipeline, rumors swirled the big California biotech could pursue a massive buyout. But early Monday morning, Gilead CEO Daniel ODay threw cold water on that, telling investors that the company was looking to expand but any changes would be bolt-on acquisitions.

In what was billed as a fireside chat, incoming Vertex CEO Reshma Kewalramani detailed the pipeline she would lead. Those assets include marketing an expanded indication for Trikafta (its not yet approved for children under 12), a drug for alpha-1 antitrypsin deficiency a lung disorder similar to cystic fibrosis their gene therapy program for sickle cell and beta thalassamia, and the potential cell therapy cure for diabetes they acquired with the $950 million Semma buyout.

The water-cooler has also buzzed with talk that Vertex could acquire CRISPR Therapeutics, their partner on the gene therapy program.

Kewalramani didnt address that. Instead, she offered a target for Vertexs most recent acquisition: bringing the cell therapy into the clinic.

Weve set an ambitious goal for ourselves with Semma, Kewalramani said. Jason Mast

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#JPM20: 'The NPV is always wrong.' Takeda preps another spinout this time on psych - Endpoints News

BURLINGTON LabCorphas introduced a suite of cell and gene therapy development services fromCovance, its drug development business, to help biopharmaceutical companies develop cell and gene therapies for cancer and other diseases.

With approximately one-third of biopharmas pipeline focused on precision medicines, it becomes even more critical to find innovative ways to help our customers speed these transformational therapies to the patients who need them, said Paul Kirchgraber, M.D., chief executive officer of Covance.

The coordinated services cover the full range of therapy development: pre-clinical, clinical and post-approval.

Pre-clinical services include pharmacology and safety assessment, biodistribution testing and services, and vector and cell characterization and qualification.

Clinical services include clinical trials with focused expertise in oncology, rare diseases and specific therapeutic areas; bioanalysis testing and services; biomarkers, including companion diagnostics; central laboratory services; and regulatory and strategic product development consultation, including clinical development and commercialization strategy.

Post-approval services include long-term follow-up studies, real-world evidence, pharmacovigilance, post-marketing commitments support, regulatory consulting and commercialization.

Cell and gene therapies, categorized as advanced therapy medicinal products (ATMPs), are more complex and specialized than traditional drugs. They typically involve correcting or replacing genetic information to restore the correct function of cells or genes for many conditions, including cancer and rare genetic diseases.

ATMPs have the potential to offer a durable, life-changing therapeutic response, possibly with a single administration, for patients who may have few or no alternative treatment options, according to the Alliance for Regenerative Medicine in Washington.

About 950 companies worldwide are developing ATMPs, and 1,052 clinical trials were under way by the end of the third quarter of 2018, according to the Alliance. Most of those trials 650 were for oncology indications.

Covance has more than 20 years of experience in supporting advanced therapies. The company said its coordinated approach to services uniquely positions it to partner with sponsor organizations to address complexity, reduce cost and risk, and accelerate timelines of their novel therapies.

In the last four years, Covance has conducted more than 300 preclinical studies and more than 40 clinical trials for cell and gene therapies globally, said Steve Anderson, Ph.D., chief scientific officer at Covance.

Covance is uniquely positioned to provide scientific and technical expertise to support the rapid growth in development of cell and gene therapies and the introduction of new regulatory pathways for these products, Anderson said. Our knowledge and experience from discovery through post-approval are significant, as demonstrated by our support of recent approvals in both cell and gene-based therapies.

Kirchgraber said Covance has made ongoing investments in people, processes and technologies targeting cell and gene therapies. The company has also grown its capabilities and capacity by forming strategic partnerships and making key acquisitions, such as the purchase in early 2019 of MI Bioresearch, a contract research organization specializing in nonclinical oncology testing, with a focus on immunotherapies and adoptive T-cell therapeutic approaches, he said.

LabCorp was established in 1969 as Biomedical Laboratories, a small pathology lab located in a hospital basement in Burlington, N.C. Over the last 50 years it has become a dominant life sciences company through mergers, acquisitions and organic growth.

LabCorp provides diagnostic, drug development and technology-enabled solutions for more than 120 million patient encounters per year. The company typically processes tests on more than 2.5 million patient specimens per week and supports clinical trial activity in about 100 countries through its central laboratory business, generating more drug safety and efficacy data than any other company.

LabCorp employs about 3,600 people in Alamance County, where it is the largest private employer, and about 7,300 across North Carolina. Its global workforce includes nearly 61,000 employees.

The company reported revenue of more than $11 billion in 2018. It announced today that it willannounce its 2019 financial resultson February 13. Its shares are traded on the New York Stock Exchange.

(C) N.C. Biotech Center

Continued here:
LabCorp, Covance launch new effort focusing on gene therapies - WRAL Tech Wire

There are currently two approved therapies for spinal muscular atrophy (SMA), Biogens Spinraza and Novartis gene therapy Zolgensma. Spinraza is priced at $750,000 for the first year and $375,000 each year afterwards. Novartis Zolgensma, which is believed to be a one-shot cure, is priced at $2.1 million. That makes it the biopharmaceutical industrys most expensive one-time treatment.

Roche is expecting the U.S. Food and Drug Administration (FDA) to approve its own SMA therapy, risdiplam, by May 24. And the company has suggested that it plans to undercut both Biogen and Novartis on price in order to make up for being third-to-market.

SMA is a rare, autosomal recessive neuromuscular disease characterized by the degeneration of alpha motor neurons in the spinal cord. This results in progressive muscle weakness and paralysis. According to the Orphanet Journal of Rare Diseases, the estimated incidence is 1 in 6,000 to 1 in 10,000 live births.

The FDA approved Zolgensma in May 2019 to treat children less than two years old with SMA that have bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma is only approved for SMA Type 1. SMA type I, the severest form, is almost always fatal by two years of age, with a 50% mortality rate by seven months and a 90% mortality rate by 12 months.

A 2009 study found that with nutritional and respiratory care, a greater percentage of those patients were living beyond two years of age. Patients with Types II and III typically live into adulthood and could potentially have a normal life expectancy, although with a great deal of healthcare services. Spinraza is approved for all types.

William Anderson, chief executive officer of Roche Pharmaceuticals, has not reported an actual projected price for risdiplam, but said it will take the same strategy it did in pricing its hemophilia A drug Hemlibra in 2017 when it took on Novo Nordisk and Takeda.

With Hemlibra, we priced at about half of bypassing agent, Anderson said in an interview at the JP Morgan Healthcare Conference in San Francisco. We aim to underwhelm with our price.

It is likely that Zolgensma, because of it being a cure rather than a treatment, will be the therapy of choice for SMA. Still, analysts project risdiplam could hit $1 billion in annual sales, and Biogens Spinraza is already raking in about $2 billion per year. Spinraza and risdiplam will likely be seen as the treatments for older patients. And risdiplam has an advantage over Spinrazait is an oral medication, whereas Spinraza requires a spinal infusion every four months.

Zolgensma is also being evaluated in older patients, but the trial has been halted because of safety concerns, although Novartis expects the FDA to approve restarting the trial.

Novartis is also working on an oral drug for SMA called branaplam. In December, its president of the Novartis Institutes for BioMedical Research, Jay Bradner, suggested the company wasnt as enthusiastic about the drug, with Bradner saying Novartis did not see a big opportunity for oral therapy there, or we would develop this molecule further.

Since then, Novartis backpedaled a bit, saying the trial of branaplam would continue and a decision on moving forward would be based on the data readout later this year.

In November 2019, Roches risdiplam met its primary endpoint in the pivotal Part 2 of SUNFISH, which evaluated risdiplam in patients aged 2-25 years with Type 2 or 3 SMA. The primary endpoint was change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year compared to placebo.

Risdiplam is an investigational survival motor neuron-2 (SMN2) splicing modifier. It is designed to increase and sustain SMN protein levels in the central nervous system and peripheral tissues.

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Roche Plans to Undercut SMA Therapy Price to Compete with Biogen and Novartis - BioSpace

Days after shaking hands with German regulators over the launch and coverage of its beta-thalassemia gene therapy, bluebird bio has wooed a Celgene exec to lead its European operations.

Nicola Heffron, a biopharma vet with stints across Eli Lilly, GSK and Shire, jumps from a brief tenure overseeing marketing for Celgenes myeloid portfolio in Summit, NJ. She will now be based in Zug, Switzerland.

Shes replacing Andrew Obenshain as he joins CEO Nick Leschly and the leadership team in Boston, according to Bloomberg, which first reported the news. Obenshains new title is chief of wings.

On Monday bluebird announced that Germany will be the first country to commercially offer Zynteglo, their procedure encoding A-T87Q-globin gene in CD34+ cells extracted from patients. Under their value-based payment scheme, the $1.8 million price is divided into five installments. After an initial payment is made at the time of infusion, the payers wait and see and only pay if the patients continue to be transfusion-free.

Multiple statutory health insurances have signed onto the plan, bluebird said, and University Hospital of Heidelberg will host the first qualified treatment center.

The biotech has been busy sorting out manufacturing specs and talking to individual countries since the EU issued an historic OK last June. Its sanctioned for a specific group of beta-thalassemia patients those who are 12 years and older, transfusion dependent, do not have a 0/0 genotype and for whom hematopoietic stem cell transplantation is appropriate but a donor is not available.

For patients with TDT, lifelong chronic blood transfusions are required in order to survive, bluebird chief commercial officer Alison Finger emphasized in a statement. Their one-time infusion promises to do away with the transfusions for good.

A rolling BLA submission to the FDA has begun, bluebird added.

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Celgene exec jumps to head bluebird bio ops in Europe, where its $1.8M gene therapy Zynteglo is now available - Endpoints News

Infographic by Dan Helmici

By Riley Holmes 1/14/20 11:43pm

A Chinese court sentenced He Jiankui (Ph.D. 10), who revealed that he had genetically-edited twin girls last year, to three years in prison on Dec. 30, 2019. The questions surrounding his PhD advisor, Rice University bioengineering professor Michael Deems involvement in the Hes experiments, remain unanswered. In November 2018, Rice began a full investigation into Deems role in the research.

According to the New York Times, He plead guilty to forging documentation from ethics committees approving the study, which he used to recruit participants. Additionally, Chinese media outlets revealed his work on a previously undisclosed third child.

Since Rices Nov. 2018 statement, no more public updates on the internal investigation of Deem have been given. The Office of Public Affairs declined to comment for this article.

In the original statement, Rice stated they had been unaware of the project.

This work as described in press reports violates scientific conduct guidelines and is inconsistent with ethical norms of the scientific community and Rice University, the statement read.

Meanwhile, Stanford Universitys investigation cleared three researchers associated with He in Spring 2019 after concluding they did not encourage or directly participate in the project, according to the New York Times coverage.

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Dr. Christopher Scott, Chair of Medical Ethics and Health Policy at Baylor College of Medicine, studies ethical, legal, social and policy implications of biotechnologies similar to the ones He used. Scott formerly taught a required research ethics course to NIH grant recipients, and also mentioned that he discussed Hes project with an ethics class at Rice last fall.

The thing that is troubling about the China case is that its not a China ethics problem, it is an international problem, Scott said. So, the question from an ethics point of view is what are the professional and ethical obligations of those folks, who have either direct knowledge of intent or knowledge that the experiment was conducted, to report this fellow?

A Chinese scientist associated with the project claimed Deem was more than just a bystander, according to an article posted on STAT news in Jan. 2019. The studys manuscript lists Deem as an author. After He announced his work at a conference in Hong Kong in Nov. 2018, Deem told the Associated Press he had met the twins parents. According to the Houston Chronicle, however, he attempted to remove his name from the paper after it was sent to journals such as Nature. The study was ultimately rejected and never published. Deem had served as Hes advisor when he completed his PhD at Rice between 2007 and 2010.

Deem did not respond to requests for comment at the time of publication. Two other bioengineering faculty members also declined to comment.

According to Scott, another issue arises with the language of the consent paperwork which described the gene-therapy experiment as a vaccination against H.I.V. The Thresher was not able to obtain a copy of the consent paperwork referenced by Scott.

When it comes to genetic editing, Scott said the unknowns and risks of these experiments differ from administering a new drug to a patient or implanting a heart device.

These are genetic effects that are felt, carried for life, and also carried in heritable ways to generations, Scott said, There has to be a commitment to understanding these sorts of things, how you follow these genetically-edited kids through adulthood, and later their children, and their childrens children - a lot of unknowns.

Two other Chinese scientists connected to Hes work were also given prison sentences, according to coverage by the New York Times. If the project had resulted in a participants death, Hes sentence might have exceeded 10 years, according to the Times.

Even though this was an uncomfortable and unfortunate event, it's really one of those teaching moments, Scott said You have to ask the question institutionally, what can be done to up the level of ethical foresight in teaching universities and research universities? That's a hard question to answer.

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Rice Ph.D graduate known as 'CRISPR Baby' scientist sentenced to three years in prison - The Rice Thresher

A recent report added by Market Study Report, LLC, on Hemophilia Gene Therapy Market provides a detailed analysis on the industry size, revenue forecasts and geographical landscape pertaining to this business space. Additionally, the report highlights primary obstacles and latest growth trends accepted by key players that form a part of the competitive spectrum of this business.

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is elaborated in the report. Along with it the market share registered by the application segment is also recorded.

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Global Hemophilia Gene Therapy Market Growth, Size, Analysis, Outlook by 2020 Trends, Opportunities and Forecast to 2025 - Technology Magazine

Global Gene Therapy Market research report provides an effective industry outlook, future trends and dynamics for market growth rate, market size and key players of the industrys information with forecast. Furthermore, report includes a brief on marketing research methodology as well as opportunities offered by the market.

This research report identifies the competitive landscape of industries to understand the competition at global level. This report study describes the projected growth of the global market for approaching years from 2019 to 2025. This research report has been aggregated on the basis of static and dynamic aspects of the businesses.

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The prominent players in the Global Gene Therapy Market:

Kite Pharma, BioVex, Novartis, Spark Therapeutics, and Others.

It further provides the profile reviews of the leading participants, their overall market shares in the global market, business strategies they have adopted, and the latest developments in their respective business in a bid to enhance the decision-making capability of the readers.

This report segments the Global Gene Therapy Market on the basis ofTypesare:

Ex Vivo

In Vivo

On the basis ofApplication,the Global Gene Therapy Market is segmented into:

Cancer Diseases

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Hereditary Disease

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Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of Gene Therapy Market these regions, from 2019 to 2025 (forecast), coveringNorth America, Europe, China, Japan, Southeast Asia, India, North America(USA, Canada and Mexico)Europe(Germany, France, UK, Russia and Italy)AsiaPacific(China, Japan, Korea, India and Southeast).

Detailed overview of Gene Therapy Market Changing market dynamics of the industry In-depth market segmentation by Type, Application etc. Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape of Gene Therapy Market Strategies of key players and product offerings Potential and niche segments/regions exhibiting promising growth

Table of Content:1 Introduction of Gene Therapy Market1.1 Study Coverage1.2 Product Introduction1.3 Study Objectives1.4 Years Considered2 Executive Summary3 Breakdown Data by Manufacturers3.1 Sales by Manufacturers3.2 Revenue by Manufacturers3.3 Manufacturing Base Distribution, Product Types3.4 Manufacturers Mergers & Acquisitions, Expansion Plans4 Breakdown Data by Type4.1 Overview4.2 Breakdown Data by Type5 Breakdown Data by Application5.1 Overview5.2 Breakdown Data by Application6 Gene Therapy Market, By Geography6.1 North America6.2 Europe6.3 Asia Pacific6.4 Central & South America6.5 Middle East and Africa6.6 Rest of the World7 Company Profiles7.1 Company Details7.2 Company Business Overview7.3 Sales, Revenue and Gross Margin7.4 Products Offered7.5 Recent Development8 Future Forecast8.1 Overview8.2 Market Forecast by Regions8.3 Sales Forecast by Regions8.4 Revenue Forecast by Regions8.5 Forecast by Type8.6 Forecast by Application9 Market Opportunities, Challenges, Risks and Influences Factors Analysis9.1 Market Opportunities and Drivers9.2 Market Challenges9.3 Market Risks/Restraints10 Appendix10.1 Research Methodology

Finally, the Gene Therapy market report offers a complete and detailed study of global Gene Therapy market by using numerous analytical tools and models such as SWOT analysis, investment return analysis, and porters five forces analysis which are useful for beginners to access the upcoming opportunities. After exploring the market insights through primary and secondary research methodologies, if anything is required except than this, market insights reports will provide customization as per specific demands.

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Report: Cell and Gene Therapy Consumables Market Industry Key Players, Size, Trends, Opportunities, Growth- Analysis to 2027 - Market Research News...

Adult bone repair relies on the activation of bone stem cells, which still remain poorly characterized. Bone stem cells have been found both in the bone marrow and in the outer layer of tissue, called periosteum, that envelopes the bone. Of the two, periosteal stem cells are the least understood.

Having a better understanding of how adult bones heal could reveal new ways of repair fractures faster and help find novel treatments for osteoporosis. Dr. Dongsu Park and his colleagues at Baylor College of Medicine investigate adult bone healing and recently uncovered a new mechanism that has potential therapeutic applications.

Previous studies have shown that bone marrow and periosteal stem cells, although they share many characteristics, also have unique functions and specific regulatory mechanisms, said Park, who is assistant professor of molecular and human genetics and of pathology and immunology at Baylor.

It is known that these two types of bone stem cells comprise a heterogeneous population that can contribute to bone thickness, shaping and fracture repair, but scientists had not been able to distinguish between different subtypes of bone stem cells and study how their different functions are regulated.

In the current study, Park and his colleagues developed a method to identify different subpopulations of periosteal stem cells, define their contribution to bone fracture repair in live mouse models and identify specific factors that regulate their migration and proliferation under physiological conditions.

The researchers discovered specific markers for periosteal stem cells in mice. The markers identified a distinct subset of stem cells that showed to be a part of life-long adult bone regeneration.

We also found that periosteal stem cells respond to mechanical injury by engaging in bone healing, Park said. They are important for healing bone fractures in the adult mice and, interestingly, they contribute more to bone regeneration than bone marrow stem cells do.

In addition, the researchers found that periosteal stem cells also respond to inflammatory molecules called chemokines, which are usually produced during bone injury. In particular, they responded to chemokine CCL5.

Periosteal stem cells have receptors molecules on their cell surface called CCR5 that bind to CCL5, which sends a signal to the cells to migrate toward the injured bone and repair it. Deleting the CCL5 or the CCR5 gene in mouse models resulted in marked defects or delayed healing. When the researchers supplied CCL5 to CCL5-deficient mice, bone healing was accelerated.

The findings suggested potential therapeutic applications. For instance, in individuals with diabetes or osteoporosis in which bone healing is slow and may lead to other complications resulting from limited mobility, accelerating bone healing may reduce hospital stay and improve prognosis.

Our findings contribute to a better understanding of how adult bones heal. We think this is one of the first studies to show that bone stem cells are heterogeneous, and that different subtypes have unique properties regulated by specific mechanisms, Park said. We have identified markers that enable us to tell bone stem cell subtypes apart and study what each subtype contributes to bone health. Understanding how bone stem cell functions are regulated offers the possibility to develop novel therapeutic strategies to treat adult bone injuries.

Find all the details of this study in the journal journal Cell Stem Cell.

Other contributors to this work include Laura C. Ortinau, Hamilton Wang, Kevin Lei, Lorenzo Deveza, Youngjae Jeong, Yannis Hara, Ingo Grafe, Scott Rosenfeld, Dongjun Lee, Brendan Lee and David T. Scadden. The authors are affiliated with one of the following institutions: Baylor College of Medicine, Texas Childrens Hospital, Pusan National University School of Medicine and Harvard University.

This study was supported by the Bone Disease Program of Texas Award and The CarolineWiess Law Fund Award, the NIAMS of the National Institutes of Health under award numbers 1K01AR061434 and 1R01AR072018 and U54 AR068069 and the NIDDK of the NIH.

By Ana Mara Rodrguez, Ph.D.

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There is a new player in adult bone healing - Baylor College of Medicine News

LONDON, UK / ACCESSWIRE / January 15, 2020 / Hemogenyx Pharmaceuticals plc (HEMO.L) ("Hemogenyx" or the "Company"), the biopharmaceutical group developing new therapies and treatments of blood diseases, is pleased to announce the following update on its activities.

As previously announced, Hemogenyx's CDX product has the potential to treat Acute Myeloid Leukemia (AML) directly as well as providing a benign conditioning regimen for blood stem cell replacement therapy. The Company has now carried out extensive work developing treatments for AML and has to date obtained encouraging results.

Hemogenyx has successfully constructed and in vitro tested Chimeric Antigen Receptor (CAR) programmed T cells (HEMO-CAR-T) for potential treatment of AML. HEMO-CAR was constructed using Hemogenyx's proprietary humanized monoclonal antibody against a target on the surface of AML cells. The Company has demonstrated that HEMO-CAR was able to programme human T cells (converted them into HEMO-CAR-T) to identify and destroy human AML derived cells in vitro.

Following the successful completion of these tests, in vivo tests of the efficacy of HEMO-CAR-T against AML are being conducted utilising a model of AML using Advanced peripheral blood Hematopoietic Chimera (ApbHC) - humanized mice developed by Immugenyx, LLC, a wholly-owned subsidiary of Hemogenyx.

Vladislav Sandler, Chief Executive Officer, commented, "We are encouraged by this new data which demonstrates our continuing progress in the development of novel treatments for blood cancers such as AML. The development of HEMO-CAR-T expands Hemogenyx's pipeline and advances it into a cutting-edge area of cell-based immune therapy. We are excited to have developed another product candidate that should, if successful, provide a new and potentially effective treatment for blood cancers for which survival rates are currently very poor."

About AML and CAR-T

AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 25% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx. The successful development of the new therapy for AML would have a major impact on treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T cells from the patient, modifying the isolated T cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the release of this announcement.

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Hemogenyx Pharmaceuticals plc

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Dr Vladislav Sandler, Chief Executive Officer & Co-Founder

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About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals plc ("Hemogenyx") is a publicly traded company (HEMO.L) headquartered in London, with its wholly-owned US operating subsidiaries, Hemogenyx LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility and a wholly-owned Belgian operating subsidiary, Hemogenyx-Cell SPRL, located in Lige.

Hemogenyx is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.

For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. Hemogenyx's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.

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Hemogenyx's CAR-T Cells are Effective Against AML in vitro - Yahoo Finance

PALO ALTO, Calif.--(BUSINESS WIRE)--Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, today announced the expansion of its Series A financing with an additional investment of $14.1 million led by Roche Venture Fund and with participation from other investors, bringing the total company financing to more than $50 million to date. The initial Series A round was led by Abingworth LLP and Qiming Venture Partners USA, with further investment from Surveyor Capital (a Citadel company) and participation from Alexandria Venture Investments, LLC.

Jasper plans to use the proceeds to advance and expand the study of its lead clinical asset, JSP191. A humanized antibody targeting CD117 on hematopoietic stem cells, JSP191 is designed to replace toxic chemotherapy and radiation therapy as conditioning regimens to prepare patients for curative stem cell and gene therapy. JSP191 is the only antibody of its kind in clinical development as a single conditioning agent for people undergoing curative hematopoietic cell transplantation.

This investigational agent is currently being evaluated in a Phase 1/2 dose-escalation and expansion study as a conditioning agent to enable stem cell engraftment in patients with severe combined immunodeficiency (SCID) who received a prior stem cell transplant that resulted in poor outcome. Initial positive results from this ongoing clinical trial were presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2019. Jasper plans to expand the Phase 1/2 clinical study to include patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) receiving hematopoietic cell transplant. The development of JSP191 is supported by a collaboration with the California Institute for Regenerative Medicine (CIRM).

About Hematopoietic Cell TransplantationBlood-forming, or hematopoietic, stem cells are rare cells that reside in the bone marrow and are responsible for the generation and maintenance of all blood and immune cells. These stem cells can harbor inherited or acquired abnormalities that lead to a variety of disease states, including immune deficiencies, blood disorders or hematologic cancers. Replacement of the defective or malignant hematopoietic stem cells in the patients bone marrow by transplantation and engraftment of healthy stem cells is the only cure for most of these life-threatening conditions. Successful transplantation is currently achieved by subjecting patients to toxic treatment with radiation and/or chemotherapy followed by transplantation of a donor or gene-corrected hematopoietic cell graft. These toxic regimens cause DNA damage and lead to short- and long-term toxicities, including unwanted damage to organs and prolonged hospitalization. As a result, many patients who could benefit from a hematopoietic cell transplant are not eligible. New approaches that are effective but have minimal to no toxicity are urgently needed so more patients who could benefit from a curative stem cell transplant could receive the procedure.

Safer and more effective hematopoietic cell transplantation regimens could overcome these limitations and enable the broader application of hematopoietic cell transplants in the cure of many disorders. These disorders include hematologic cancers (e.g., myelodysplastic syndrome [MDS] and acute myeloid leukemia [AML]), autoimmune diseases (e.g., lupus, rheumatoid arthritis, multiple sclerosis and Type 1 diabetes), and genetic diseases that could be cured with genetically-corrected autologous stem cells (e.g., severe combined immunodeficiency syndrome [SCID], sickle cell disease, beta thalassemia, Fanconi anemia and other monogenic diseases).

About JSP191JSP191 (formerly AMG 191) is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow. JSP191 binds to human CD117, a receptor for stem cell factor (SCF) that is expressed on the surface of hematopoietic stem and progenitor cells. The interaction of SCF and CD117 is required for stem cells to survive. JSP191 blocks SCF from binding to CD117 and disrupts critical survival signals, causing the stem cells to undergo cell death and creating an empty space in the bone marrow for donor or gene-corrected transplanted stem cells to engraft.

Preclinical studies have shown that JSP191 as a single agent safely depletes normal and diseased hematopoietic stem cells, including in an animal model of MDS. This creates the space needed for transplanted normal donor or gene-corrected hematopoietic stem cells to successfully engraft in the host bone marrow. To date, JSP191 has been evaluated in more than 80 healthy volunteers and patients. It is currently being evaluated as a sole conditioning agent in a Phase 1/2 dose-escalation and expansion trial to achieve donor stem cell engraftment in patients undergoing hematopoietic cell transplant for SCID, which is curable only by this type of treatment. For more information about the design of the clinical trial, visit http://www.clinicaltrials.gov (NCT02963064). Clinical development of JSP191 will be expanded to also study patients with AML or MDS who are receiving hematopoietic cell transplant. IND-enabling studies are planned to advance JSP191 as a conditioning agent for patients with other rare and ultra-rare monogenic disorders and autoimmune diseases.

About Jasper TherapeuticsJasper Therapeutics is a biotechnology company focused on hematopoietic cell transplant therapies. The companys lead compound, JSP191, is in clinical development as a conditioning antibody that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplant. This first-in-class conditioning antibody is designed to enable safer and more effective curative hematopoietic cell transplants and gene therapies. For more information, please visit us at https://jaspertherapeutics.com.

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Jasper Therapeutics Announces Expansion of Series A Financing, Bringing Total Corporate Fundraising to More than $50 Million - Business Wire

Pete McCleave pictured with his children

Sleights residents, June and Mike McCleave's son Peter has Myeloma, a type of bone marrow cancer for which there is currently no cure.

Peter, 42, was diagnosed with the disease three years ago, and time is running short for the man who two years ago was given just seven years to live.

The family is now in a race against time to find a matching stem cell donor, who can provide the transfusion that will extend Peter's life, hopefully long enough for a cure to be found.

Mum, June, said: "We go to myeloma conferences which give details of all the updated work and drugs that are available. They are very hopeful of a cure and are working on one which involves gene therapy, meaning that good cells will attack the cancer. They reckon that in ten years there will be a cure for this."

Peter has been determined to fight the disease. He set up a campaign called 10,000 donors to encourage as many people as possible to register with DKMS, the charity dedicated to defeating blood cancer. To date 33,402 donors have registered because of this campaign and 12 donor matches have been confirmed, Pete is still waiting.

June and Mike have organised an event at Eskdale School for people to go along and take a cheek swab test to see if they are a compatible match for Peter, or others who have the disease.

The event takes place of Tuesday, January 14 from 4.00pm to 7,00pm.

Taking the test is simple and pain free, three cotton swabs (like cotton buds) collect saliva from inside the mouth and are sent for testing. It's a process which is over in seconds, with one swab collecting saliva from the left cheek, one from the right cheek and one from around the mouth.

A DKMS representative will be at the session and will take the swabs to the laboratory for analysis, you will then receive a card a few weeks later confirming you are registered as a potential donor.

See more here:
Sleights family's appeal for blood stem cell donor in Whitby - The Scarborough News

Sickle cell disease is a painful condition that thousands of kids have to endure. The genetic disease impacts the blood, but it can cause organ damage and other issues, including lots of pain.

Most of the time there is no end in sight, which makes it even harder on families. But the bravery of one teen is helping scientists to develop a potential cure that could change the lives of so many.

Helen Obando recently became the youngest person to ever go through a special gene therapy using stem cells.

The usual treatment for sickle cell therapy is a bone marrow transplant form a healthy sibling, but Helen's older sister Haylee also has sickle cell, so that isn't really an option for the family.

The Obandos were excited to learn about an experimental treatment that has the potential to flip the switch on the genetics and actually cure the disease.

Scientists are hoping that the new treatment could help people with a number of genetic conditions using a technique to manipulate the DNA.

Helen had to spend four weeks in the hospital after her infusion to get strong enough to go home, and they don't know yet if the treatment has worked.

The poor girl has gone through a lot. Her pelvis was harmed before she even turned 1, and at 2, her spleen had to be removed. She's had a lot of painful episodes, and while Haylee was able to match with their younger brother Ryan for a bone marrow transplant, that wasn't an option for Helen.

In the Boston Globe, Helen's mom said that she was scared of the gene therapy option when she first heard of it. But she decided that it was worth the risk to have a chance at being healthy.

Six months since the treatment, it's so far, so good. Helen's hemoglobin levels are at a point that she has never achieved. She actually has no signs of sickle cell right now, and that is just amazing.

What a brave girl to go through a risky procedure.It's a big burden for a teenager to bear, but luckily things have worked out well so far. We hope that Helen continues to find success and health in the new year.

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Helen Obando Is The Youngest To Successfully Undergo Sickle Cell Therapy - Moms

Cancer enters your body when cells begin to grow out of control. There are various types of cancer and cells in almost every part of the body can become cancer. Leukemia is a type of cancer which starts in the cells, then develops into different types of blood cells. It starts in early forms of white blood cells. There are different types of leukemia which can be divided into acute and chronic. Acute is fast growing and chronic is slow growing.

An Acute Lymphoblastic Leukemia is a type of leukemia which progresses quickly and if not treated, will be fatal in a couple of months. Acute means fast growing and lymphatic means it develops from the early forms of lymphocytes, which is a type of white blood cell. It all starts in the bone marrow and leukemia cells start to invade the body quickly. They can spread to other parts of the body. Some cancers also start in the organs and then spread to the bone marrow, but they are not leukemia.

There are other types of cancer which start in lymphocytes and are known as lymphomas. Leukemias affect blood and bone marrow and lymphomas affect lymph nodes and other organs. It can sometimes be difficult to tell if a cancer of lymphocytes is lymphoma or leukemia. If at least 20% of the bone marrow has cancerous lymphocytes, the disease is considered to be leukemia. Acute Lymphoblastic Leukemia is the most common childhood cancer and children below the age of five are at the highest risk. It can also occur in adults.

RELATED:Kids Born To Obese Mothers Are More Likely To Develop Leukemia

ALL can increase the chances of bleeding and developing infections in the body. Its symptoms include:

In order to diagnose ALL, the doctor must complete a physical exam and also conduct bone marrow tests and blood tests. Doctors are likely to ask about bone pain, since it is the most common symptom of ALL. Here are a few tests doctors carry out.

The doctor might order a blood count, and people who have ALL may have a blood count which shows low platelet count and a low hemoglobin count. The WBC may or may not have increased. A blood smear might show immature cells circulating in the blood, which are usually found in bone marrow.

This process involves taking a sample of the bone marrow from your breastbone or the pelvis. It is an ideal way to test for increased growth in marrow tissue and reduced production of red blood cells.

An X-ray of the chest can allow the doctor to see if the mediastinum, that is the middle partition of the chest is widened. Further, a CT scan can help the doctor estimate whether the cancer has spread to the spinal cord, brain or to any other part of the body.

There are other tests like a spinal tap, which is used to check if cancer cells have spread around the spinal fluid. Tests on the serum urea and liver function might also be done.

The treatment will help bring the count back to normal. When this happens and the bone marrow looks normal, the cancer is in remission. Acute Lymphoblastic Leukemia can be treated through chemotherapy. You might be asked to stay at the hospital for a few weeks in the first treatment. Later, you can continue the treatment as an outpatient.

For those with a low WBC count, you will be asked to spend time in an isolation room. It ensures that you are protected from contagious diseases and other problems. If leukemia does not respond to chemotherapy, a bone marrow or stem cell transplant might be recommended. The transplanted marrow can be taken from a sibling who is a complete match.There are high chances of cancer remission in case of children.

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You're Probably Ruining Your Teenager's Life & Here's What You're Doing Wrong

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Criss Angel's Son Has Acute Lymphoblastic Leukemia, But What Is It? - Moms

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) announced the launch in Germany of ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. This is the first time ZYNTEGLO is commercially available.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in significantly reduced or absent adult hemoglobin (HbA). In order to survive, people with TDT maintain hemoglobin (Hb) levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload. ZYNTEGLO is a one-time gene therapy that addresses the underlying genetic cause of TDT and offers patients the potential to become transfusion independent, which, once achieved, is expected to be lifelong.

Due to the highly technical and specialized nature of administering gene therapy in rare diseases, bluebird bio is working with institutions that have expertise in stem cell transplant as well as in treating patients with TDT to create qualified treatment centers that will administer ZYNTEGLO. bluebird bio has established a collaboration with University Hospital of Heidelberg as the first qualified treatment center in Germany.

In addition, bluebird has entered into value-based payment agreements with multiple statutory health insurances in Germany to help ensure patients and their healthcare providers have access to ZYNTEGLO and that payers only pay if the therapy delivers on its promise. bluebirds proposed innovative model is limited to five payments made in equal installments. An initial payment is made at the time of infusion. The four additional annual payments are only made if no transfusions for TDT are required for the patient.

For patients with TDT, lifelong chronic blood transfusions are required in order to survive. We are thrilled to announce that ZYNTEGLO will now be available for patients in the EU living with this severe disease, says Alison Finger, chief commercial officer, bluebird bio. In addition to confirming manufacturing readiness of our partner, apceth Biopharma GmbH, bluebird has also submitted a dossier to the Joint Federal Committee (G-BA) in Germany for drug benefit assessment. We would like to thank our collaborators for their commitment in helping us transform the healthcare system by accepting innovative payment models, and we look forward to treating our first commercial patient soon.

About LentiGlobin for -Thalassemia (autologous CD34+ cells encoding A-T87Q-globin gene)

The European Commission granted conditional marketing authorization for LentiGlobin for -thalassemia, to be marketed as ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene) gene therapy, for patients 12 years and older with TDT who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

LentiGlobin for -thalassemia adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during the HGB-204, HGB-207 and HGB-212 clinical studies that were attributed to LentiGlobin for -thalassemia were hot flush, dyspnoea, abdominal pain, pain in extremities, thrombocytopenia, leukopenia, neutropenia and non-cardiac chest pain. One serious adverse event (SAE) of thrombocytopenia was considered possibly related to LentiGlobin for -thalassemia for TDT.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The conditional marketing authorization for ZYNTEGLO is valid in the 28 member states of the EU as well as Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration (FDA) granted LentiGlobin for -thalassemia Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT. LentiGlobin for -thalassemia is not approved in the United States.

bluebird bio has initiated the rolling BLA submission for approval in the U.S., and is engaged with the FDA in discussions regarding the requirements and timing of the various components of the rolling BLA submission. Subject to these ongoing discussions, the company is currently planning to complete the BLA submission in the first half of 2020.

LentiGlobin for -thalassemia continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207) or NCT03207009 for Northstar-3 (HGB-212).

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of LentiGlobin for -thalassemia. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

ZYNTEGLO, LentiGlobin, and bluebird bio are trademarks of bluebird bio, Inc.

The full common name for ZYNTEGLO: A genetically modified autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiviral vector encoding the A-T87Q-globin gene.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Companys plans and expectations for the commercialization for ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene, formerly LentiGlobin in TDT) to treat TDT, and the potential implications of clinical data for patients. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the efficacy and safety results from our prior and ongoing clinical trials of ZYNTEGLO will not continue or be repeated in our ongoing or planned clinical trials of ZYNTEGLO; the risk that the current or planned clinical trials of ZYNTEGLO will be insufficient to support regulatory submissions or marketing approval in the US, or for additional patient populations in the EU; the risk that the production of HbAT87Q may not be sustained over extended periods of time; the risk that we may not secure adequate pricing or reimbursement to support continued development or commercialization of ZYNTEGLO; the risk that our collaborations with qualified treatment centers will not continue or be successful; and that the risk that commercial patients treated with ZYNTEGLO will not achieve or maintain transfusion independence. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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bluebird bio Announces Launch in Germany of ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older...

SERGIEV POSAD ( RUSSIA ): When Alexei Voronenkovs 70-year-old mother passed away, he paid to have her brain frozen and stored in the hope breakthroughs in science will one day be able to bring her back to life. It is one of 71 brains and human cadavers which Russian company KrioRus calls its patients floating in liquid nitrogen in one of several metres-tall vats in a corrugated metal shed outside Moscow.'; var randomNumber = Math.random(); var isIndia = (window.geoinfo && window.geoinfo.CountryCode === 'IN') && (window.location.href.indexOf('outsideindia') === -1 ); console.log(isIndia && randomNumber They are stored at -196Celsius (-320.8F) with the aim of protecting them against deterioration, although there is currently no evidence science will be able to revive the dead. I did this because we were very close and I think it is the only chance for us to meet in the future, said Voronenkov who intends to undergo the procedure, known as cryonics, when he dies. The head of the Russian Academy of Sciencess Pseudoscience Commission, Evgeny Alexandrov, described cryonics as an exclusively commercial undertaking that does not have any scientific basis, in comments to a newspaper. KrioRus says hundreds of potential clients from nearly 20 countries have signed up for its after-death service. It costs $36,000 for the whole body and $15,000 for brain alone for Russians, who earn average monthly salaries of $760, according to statistics. Prices are higher for non-Russians.Voronenkov said he set his hopes on science. I hope one day it reaches a level when we can produce artificial organs to create an artificial body where my mothers brain can be integrated.

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Brain freeze: New path to immortality - Times of India

ReutersJan 15, 2020 09:42:25 IST

When Alexei Voronenkovs 70-year-old mother passed away, he paid to have her brain frozen and stored in the hope breakthroughs in science will one day be able to bring her back to life.

It is one of 71 brains and human cadavers which Russian company KrioRus calls its patients floating in liquid nitrogen in one of several metres-tall vats in a corrugated metal shed outside Moscow.

They are stored at -196 degrees Celsius (-320.8F) with the aim of protecting them against deterioration, although there is currently no evidence science will be able to revive the dead.

I did this because we were very close and I think it is the only chance for us to meet in the future, said Voronenkov who intends to undergo the procedure, known as cryonics, when he dies.

A Russian company will freeze your brain or your entire body in the hopes of reviving you when the tech is available. Image credit: Friso Gentsch/Getty Images

The head of the Russian Academy of Sciences' Pseudoscience Commission, Evgeny Alexandrov, described cryonics as an exclusively commercial undertaking that does not have any scientific basis, in comments to the Izvestia newspaper.

It is a fantasy speculating on peoples hopes of resurrection from the dead and dreams of eternal life, the newspaper quoted him as saying.

Valeriya Udalova, KrioRuss director who got her dog frozen when it died in 2008, said it is likely that humankind will develop the technology to revive dead people in the future, but that there is no guarantee of such technology.

KrioRus says hundreds of potential clients from nearly 20 countries have signed up for its after-death service.

It costs $36,000 for a whole body and $15,000 for the brain alone for Russians, who earn average monthly salaries of $760, according to official statistics. Prices are slightly higher for non-Russians.

The company says it is the only one in Russia and the surrounding region. Set up in 2005, it has at least two competitors in the United States, where the practise dates back further.

Voronenkov said he set his hopes on science. I hope one day it reaches a level when we can produce artificial bodies and organs to create an artificial body where my mothers brain can be integrated.

KrioRus director Udalova argues that those paying to have dying relatives remains preserved are showing how much they love them.

They try to bring hope, she said. What can we do for our dying relatives or the ones that we love? A nice burial, a photo album, she said. They go further, proving their love even more.

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Russian company will freeze your brain in the hopes of reviving you in the future with better tech - Firstpost

In the past, the most common thing to do was a traditional burial, but that is no longer the case. According to the report, the majority of Americans now plan on being cremated (44%), with traditional burials coming in second (35%).

That leaves one in five Americans (21%) who have other plans for their body.

Some (6%) choose to donate their bodies to science, while others (4%) opt for a natural burial being buried without a casket, directly in the ground.

Others have opted for more unique arrangements, such as mummification, having their ashes launched into space or being turned into a memorial diamond. Such options are not cheap.

Mummification a lengthy process in which a persons skin and flesh are preserved is the costliest, starting at $67,000 (all figures in U.S. dollars).

Plastination a process in which the body is drained of all fluids and filled with a plastic-like substance starts at $40,000.

Cryonics which will freeze your clients body at a temperature low enough that the body wont decompose is a relative bargain, starting at only $20,000.

The average cost for a traditional burial is $7,360 and thats without a burial plot or headstone. Cremation is a slightly cheaper option, coming in at $6,260, but that doesnt include the cost of a viewing and memorial services.

If your client is looking for a more affordable option, donating their body to science is free.

While cremation has become the most common option, what people are doing with their ashes varies.

The most popular option among respondents was having their ashes spread in a specific location (40%), followed by having their family keep the ashes (36%).

Ten per cent of respondents chose to mix their ashes with soil and be planted as a tree, while 14% chose something more creative, such as being painted onto a canvas, turned into a coral reef, compressed into a diamond, mixed with ink and used for a tattoo or used in fireworks.

Having your ashes launched into space costs upward of $2,500, and having them planted as a tree starts at $50.

Thirteen per cent of respondents said financial reasons influenced their burial plans. More people were influenced by personal beliefs (47%) and family traditions (24%).Yet, nearly one-third of respondents (30%) said they would choose differently if they did not have to take these factors into account.

Choice Mutual surveyed 1,500 people in the United States about their burial plans and preferences. Read the full report here.

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Mummification or being launched into space? Burial options for your client - Investment Executive

It seems few can resist the revenue that can await a cancer treatment.

After over a decade extending the half-life of medicines for J&J, Genentech and other large players, Amunix is pivoting to develop elements of its platform into two approaches to immuno-oncology, one of which is an off-the-shelf alternative to CART treatments. And theyre licensing a portion of the older technology to Roche for $40 million and $1.5 billion in potential milestones.

Roche had been playing around with the tech for a tech assessment for quite a bit of time prior to my joining and they obviously like what they saw, Angie You, Amunixs new CEO, told Endpoints News.

Roche isnt disclosing what drugs it will use on Amunixs old platform, known as XTEN, for, but You said it will be for a very circumscribed indication and a very circumscribed target. It also wont be in oncology. The Swiss giant had toyed with the half-life-extending platform for 4 or 5 years before recently giving Amunix word they wanted to license it, You said.

Amunix will funnel that money into their emerging immuno-oncology approach. They first pivoted over a year ago, bringing in You as a new CEO and Rich Heyman as chairman, and soon rotating out the rest of the C-suite.

That period also saw the biotech license the new immuno-oncology platform to Merck. With a similar approach to the one employed by the recently launched Werewolf Therapeutics, Amunix will try to get the bodys T cells to attack solid tumors without triggering the toxicity T cell engagement has caused in other studies. It takes the polypeptide chains it once used to extend half-lives and combines them with proteases to essentially mask the drugs until they reach the tumor.

Were solving the problem of toxicity, You said.

Amunix limited the Roche deal so it could continue to license its older platform for other targets and indications, You said, part of an effort to continue drawing funds for the immuno-oncology effort.

We wanted to make sure we had other deals to collaborate with big pharma, she said.

Continued here:
Merck-partnered biotech hands Roche its half-life extension tech as it pivots to immuno-oncology - Endpoints News

While we embark on yetanother trip around the sun entering a new decade in 2020, thoughts naturally stray to our own mortality and ways we can improve future days via simple changes in our diet, exercise, and stress levels. But the generic nematode worm might hold clues to extending our Earthly lives far beyond the dreams of our imagination, or the furthest reaches of any insurance company actuary report.

In a new studypublished in the online journalCell Reports, a team ofinternational researchers has discovered methods to increase the lifespan of the lowly C. elegans worm by five times, long after its normal three or four week lifecycle. If these findings were successfully applied to human beings, that person would experiencethe equivalent of blowing out 400 birthday candles on a celebratory cake.That's a big cake, and scientists associated with the startling project see the data as a vital stage in someday seeing it asreality.

By genetically manipulatinginsulin/insulin-likesignaling pathways in molecules insidenematode cells, researchers have built upon previous findings linking two specific pathways the insulin signaling pathway and the target of rapamycin pathway tothe aging process. Scientists then determinedthat changing the insulinpathway doubled a worms longevity, while altering the rapamycin pathway only increasedit 30 percent.

However, in what came as an obvious surprise to the team, when both C. elegans pathways were altered, this boosted their lifespans up to a whopping 500 percent instead of 130 percent.

The synergistic extension is really wild, MDI Biological Laboratory's lead study author Jarod Rollins said in apress release. The effect isnt one plus one equals two, its one plus one equals five. Our findings demonstrate that nothing in nature exists in a vacuum; in order to develop the most effective anti-aging treatments we have to look at longevity networks rather than individual pathways.

Due to the number of shared genes and cellular pathways, C. elegans are perfect for carrying out advanced research on human aging and cutting-edgeexperiments in life extension. And because of their brieflifespans, immediate changes in their aging can be observed more readily. The logical progression of this newfound information would be to apply the resulting knowledge to Mankind in order to greater understand our own mortality and its eventual limitations.

Despite the discovery in C. elegans of cellular pathways that govern aging, it hasnt been clear how these pathways interact, MDI Biological Laboratory President Hermann Haller added. By helping to characterize these interactions, our scientists are paving the way for much-needed therapies to increase healthy lifespan for a rapidly aging population.

Are you prepared to live nearly half a millennium, or satisfiedwith a solid 80 years or soon our spinningBig Blue Marble?

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Want to live 400 years? These simple nematode worms might show humans how - SYFY WIRE

As the U.S. Air Force advances its planned B-52 reengining program, Middle River Aerostructure Systems (MRAS) is ready to provide the companys expertise in highly efficient, cost-effective nacelle systems for the operational lifetime extension of this long-range strategic bomber.

MRAS is uniquely positioned as the original equipment manufacturer of key nacelle components for the various engine versions under consideration for B-52 reengining.

Nacelle solutions for the CF34-10A, Passport, PW800 and BR725

For the CF34-10A engine, MRAS developed the fuselage-mounted nacelle system components consisting of the air inlet, fan cowl and thrust reverser that are in service today on the current generation of regional jets. MRAS understands the challenges of packaging short-duct nacelle components in the side-mounted and under-wing configurations, and brings innovative product solutions to support the integration effort.

MRAS has the lead industrial role on the nacelle system for the Passport engines that power Bombardiers Global 7500 business jets, developing and producing the nacelles air inlet and fan cowl.

Features of the Passport nacelle air inlet include an innovative anti-ice system that uses a directed flow nozzle concept; and a 360-degree, single-piece extended inner barrel incorporating advanced acoustic protection for lower engine noise levels. This nacelles fan cowl was designed for simplicity and has an overall length of 103 inches, which allows improved access for on-aircraft maintenance while lowering the system weight.

MRAS solutions offered for the Passport also can be easily adjusted to fit other long-duct engine options for B-52 reengining, such as the Pratt & Whitney PW800 and the Rolls-Royce BR725.

MRAS state-of-the-art manufacturing resources

The MRAS production site at Middle River, Maryland (on the Chesapeake Bay near Baltimore) is among the most modern of its type, with the companys multi-million-dollar investments in automation bringing the full advantages of outstanding manufacturing quality, improved cycle times and cost savings, along with the ability to rapidly introduce and increase production capacity.

In offering complete solutions for the development, production and support of aircraft nacelles and aerostructures in both metallic and composite materials, MRAS state-of-the-art production resources include automated fabrication; along with robotic assembly, painting and finishing all of which are linked via a strict adherence to the digital thread from engineering concept to the factory floor.

One of the recent additions at Middle River is a computer-controlled robotic assembly cell. Its multi-axis robot uses the nacelle components actual engineering model for high accuracy during the assembly actions, which include drilling, countersinking and the installation of fasteners.

Complete program expertise at Middle River from concept to delivery

Contributing to MRAS role as a low-risk solution provider for B-52 reengining is the companys unique end-to-end program expertise, from development, design, integration and testing to flight test support and certification all centered in the companys 1.7-million sq. ft. facility at Middle River.

This under one roof capability covers a full scope of design and analysis toolsets to develop weight- and cost-optimized designs, as well as focusing on lean principles and continuous improvement to realize and industrialize products to the most stringent demands. It also enables MRAS assembly group to work in close coordination with the companys designers ensuring optimum producibility for structures and parts.

At Middle River, MRAS maintains a rapid prototyping capability, combining virtual and physical protypes as well as 3D printing to optimize development cycle time and support the earliest possible transition to flight test operations.

MRAS specialties and competencies include bird strike, lightning strike, impact testing and analysis correlation; digital product assemblies and kinematic simulations; computational fluid dynamics (CFD) and thermal management analyses; aero acoustics, mechanical and static fatigue analyses; definition and validation of anti-icing and fire protection; along with in-depth mechanical testing.

A proven aviation heritage at Middle River spanning nine decades

All of MRAS current capabilities builds on the companys 90-year history of supporting military and civilian aircraft programs, with its propulsion-related industrial activities including a key role in the U.S. Air Force C-5M Super Galaxy reengining performing the design and certification for the CF6-80C2 powerplants thrust reverser.

In addition, MRAS manufactured the translating cowl thrust reverser for the C-5 Galaxys original TF39 engines, and it designed and produced the exhaust nozzle for C-130J Hercules airlifters.

Another program that highlighted MRAS experience in military aircraft modification and service life extension was the production of aerostructures for the P-3 Orions Aircraft Service Life Extension Program (ASLEP) and Mid-Life Upgrade (MLU). Performed from 1995 to 2019, this involved replacing fatigue-critical structural components on the P-3 maritime patrol aircraft with new enhanced-design corrosion-resistant elements thereby extending the airframe life to 15,000 flying hours and adding decades of service. MRAS delivered 90-plus shipsets that primarily involved horizontal stabilizer assemblies and leading-edge assemblies, along with 24 longeron welded assemblies.

The companys heritage traces its roots to aviation pioneer Glenn Martin, with more than 10,000 aircraft built at the Middle River production site that ranged from B-26 Marauder bombers, P5M naval flying boats and multi-role B-57 Night Intruders to Pan American Airways iconic M-130 China Clipper and the Martin 404 airliner.

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MRAS is Uniquely Positioned to Offer Cost-Effective, Low-Risk Nacelle Solutions for the Reengining of USAF B-52 Bombers - AviationPros.com

- SHP656 program utilized Xenetic's PolyXen platform technology to conjugate polysialic acid to therapeutic blood-clotting factors - Phase 1/2 study demonstrated SHP656's efficacy and pharmacokinetic data commensurate with the profile of an extended half-life rFVIII product

FRAMINGHAM, MA / ACCESSWIRE / January 14, 2020 / Xenetic Biosciences, Inc. (XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized chimeric antigen receptor T cell ("CAR T") platform technology engineered to target patient-specific tumor neoantigens, announced today that data from the completed Phase 1/2 clinical study of SHP656 ("PSA-recombinant Factor VIII", "PSA-rFVIII") sponsored by its license partner Takeda Pharmaceuticals Company Limited ("Takeda") has been published in the journal Haemophilia1.

The results from this single-dose study indicate that polysialylation of rFVIII confers a half-life extension similar to that of approved extended half-life products that use either PEG or Fc fusion technology and was not associated with any treatment-emergent adverse events.

The Phase 1/2 clinical study was conducted by Baxalta US Inc, a Takeda company, to evaluate SHP656, which was being developed as a long-acting therapeutic for the treatment of hemophilia A utilizing Xenetic's PolyXen technology to conjugate polysialic acid to therapeutic blood-clotting factors.

Jeffrey Eisenberg, Chief Executive Officer of Xenetic, commented, "We are pleased that this study published in the peer-reviewed journal Haemophilia has demonstrated that our PolyXen platform successfully extended the circulating half-life of rFVIII with no treatment-related adverse events."

Data from SHP656 was also published in the Journal of Pharmaceutical Sciences2 in an article titled, "Polysialic Acid-Mediated Activity Measurement of Polysialylated Recombinant Coagulation Factor VIII," and in the Journal of Pharmacology and Experimental Therapeutics3 in an article titled, "Evaluation of Factor VIII Polysialylation: Identification of a Longer-Acting Experimental Therapy in Mice and Monkeys."

PolyXen is Xenetic's patent-protected platform technology for creating next-generation protein or peptide therapeutics, by prolonging a drug's circulating half-life and potentially improving other pharmacological properties.

With the Phase 1/2 study completed in May 2017, SHP656 is no longer part of an active development program.

Takeda currently has one active development program underway utilizing the PolyXen platform technology, under an Exclusive License Agreement with Xenetic in the field of coagulation disorders. In addition, in October 2017 Xenetic granted rights to Takeda to grant a nonexclusive sublicense to certain patents related to PolyXen to a third party, and Xenetic receives royalties under that arrangement in the near term.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART, a personalized CAR T platform technology engineered to target patient-specific tumor neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas. XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.

Additionally, Xenetic is leveraging PolyXen, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

For more information, please visit the Company's website at http://www.xeneticbio.com and connect on Twitter, LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including, but not limited to, statements regarding the Company's plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas; the Company's expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications; and the Company's expectations regarding potential royalties resulting from the sublicense with Takeda commencing in the near term. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs, charges or expenses resulting from the acquisition of the CAR T technology; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of the CAR T technology; (3) failure to realize the anticipated potential of the XCART technology; (4) the ability of the Company to implement its business strategy; and (5) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, periodic current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

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Xenetic Biosciences, Inc. Announces Publication of Data from Partner's Phase 1/2 Study Evaluating Program Leveraging Polyxen(R) Platform Technology -...

In its latest analysis of satellite manufacturing and launch services, Satellites to be Built and Launched by 2028, Euroconsult projects that the satellite market will experience a radical transformation in the quantity, value and mass of the satellites to be built and launched with a four-fold increase in the number of satellites at a yearly average of 990 satellites to be launched, compared to a yearly average of 230 satellites in the previous decade.

The market will reach $292 billion over the next decade. This reflects a 28 percent increase over the previous decade which totalled $228 billion in revenues.

"Newcomers like Oneweb, SpaceX's Starlink or Amazon's Project Kuiper are becoming the largest owners of assets in orbit, challenging the satellite industry in many ways" said Maxime Puteaux, Editor-in-Chief of this research product and Senior Consultant at Euroconsult.

These changes are characterized by several factors:

+ LEO and MEO constellations are expected to account for 77 percent of the projected demand in the next decade driven by broadband projects like SpaceX's Starlink, Oneweb, Amazon's Project Kuiper, Telesat LEO and SES's O3b mPOWER.

+ Incumbent GEO comsat commercial satellite operators are transitioning from a legacy of GEO comsat broadcasting business to more data-centric use cases, impacting satellites orders. The gradual recovery of contracts will continue, following the low point of seven awards in 2017 with demand driven by the first orders of satellites with fully reconfigurable digital payload.

+ Euroconsult expects an average of 13 GEO comsat orders per year post-2020 based on a replacement scenario that considers the competition of NGSO satellite systems and the introduction of life extension services. Demand from global and regional GEO comsat operators will reach a yearly average of $8 billion over the next ten years.

+ Civil government agencies are projected to be the top drivers of satellite demand, accounting for 40 percent of the entire market value, ahead of both defense and commercial demand. This is a result of increasing interest in space science, exploration, and Earth observation. On the defense side, a new cycle of orders is beginning with new strategies and replacement satellites needed by the U.S., China, Russia, Japan, India and Europe.

Satellites to be Built and Launched by 2028 is a research product based on in-depth analysis of satellite applications and missions, satellite operators and users, technology advances, and the impact of these factors on the manufacturing and launch industry.

It includes a database of all satellites, regardless of mass, that were launched from 2009 to 2019, as well as satellites currently under construction, and those forecast to launch by 2028. It also provides detailed status and maturity assessments of 55 commercial constellations of five satellites or more and discusses the business cases for the four mega-constellations and their differing vertical integration strategies.

In its analysis, Euroconsult reviews strategic issues and trends for four categories of satellite operators, six types of orbit, six regions of the world, and seven distinct satellite application categories.

It provides quantitative analysis of satellite numbers, mass, and cost with forecasts based on qualitative top-down and bottom-up assessments. With separate sections for both the manufacturing and launch industries, the research covers strategic issues, industry structure, financial performance, innovation and more for each and includes detailed profiles of ten manufacturers and four launch service providers.

"While accurate projections can be challenging in an era of uncertainty, Euroconsult stands behind its numbers as the most realistic and reliable in the industry" said Maxime Puteaux. "This is the 22nd edition of our research on satellites to be built and launched and, in preparation, we compared past forecasts to the actual numbers. We confirmed that our depth of experience and comprehensive insight into the industry resulted in highly credible estimates."

Euroconsult compared the number of GEO and non-GEO satellites launched from 2009 to 2018 to its forecast for that period. It showed that, in 2009, the company predicted 11 percent more non-GEO satellites than actually launched, and it underestimated the number of GEOs by only three percent. The 2010 edition was the first report since 2000 to underestimate the non-GEO segment and subsequent editions corrected earlier over-estimates.

Related LinksEuroconsult GroupThe latest information about the Commercial Satellite Industry

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Euroconsult forecasts satellite demand to experience a four-fold increase over the next 10 years - Space Daily