Archive for July, 2020

With genetic engineering, we will be able to increase the complexity of our DNA, and improve the human race. But it will be a slow process, because one will have to wait about 18 years to see the effect of changes to the genetic code. - Stephen Hawking

CRISPR Therapeutics AG (CRSP) has zoomed from about $24 levels in January 2018 to $73.09 as of June 25, 2020, and thats a massive appreciation of about 300% in a space of 30 months. It is an efficiently managed and profitable gene-editing company that looks all set to go places once the COVID-19 disruption is contained.

Im bullish on biotech and innovative technologies within the healthcare sector and have been tweeting and reporting about relevant stocks and ETFs in The Lead-Lag Report from as early as February 2020.

Image Source: Twitter

Though I am bullish on CRSP as a long-term pick, now is not the right time or price to invest in it. COVID-19 cases have started spinning out of control, and while we may not experience another lockdown, the surge in cases can disrupt the companys operations. Before spelling out the strategy to be followed, here are a few facts:

In its Q1 2020 filing with the SEC, the company has listed the following COVID-19-specific risks to its operations:

1. The companys clinical trials for products developed for the treatment of hemoglobinopathies and immuno-oncology-based treatment have been impacted. According to the company, COVID-19 disruption will continue to impact these trials adversely in future too, due to a variety of reasons, including: (A) ICU beds that are required for trials have been diverted for treating the virus-infected; (B) Investigators did/may not want to expose candidates to COVID-19, and (C) Shortage of staff at the trial location.

2. Some of the suppliers of the company (e.g., materials, drugs, quality testing, and samples) have paused their operations.

3. Most of the companys staff was in WFH mode as of late April 2020.

These factors have impacted the companys operations as of late April 2020, and even though many facilities had reopened in May 2020, some or many may now again be impacted by the virus resurgence. The point is that as long as the COVID-19 disruption continues, CRSPs trials and operations will continue to be impacted, upsetting its pipeline. No medical research organization is sure how and by when the virus will be contained.

The global gene therapy market is estimated to grow at an annualized rate of 40% in the next 10 years. In money terms, it is expected to be worth $10 billion by 2030.

Image Source: Roots Analysis

As per Roots Analysis, a research firm, the gene-editing market is likely to witness a small decline during the COVID-19 disruption. Once the virus is contained, or when there is clarity on virus containment, the gene-editing market will get back on its growth path.

As of Q1 2020, CRSP has $889.7 million cash and equivalents in its books. This accumulated cash is not because of past operational profits, but because the company has issued stock in the last 3 years.

Image Source: Seeking Alpha

Between 2018 and 2020, the company has issued $1.15 billion worth of stock and now looks very richly valued. Here are a few numbers:

1. CRSPs TTM P/E (GAAP) is a whopping 95.41 as compared to the sector median of 33.93.

2. Its TTM EV/EBITDA is a massive 131.30 as compared to the sector median of 17.70.

3. The Forward Price/Sales is way too high at 247.50 versus the sector median of 7.71.

Slice or dice it any which way, CRSP is a very expensive stock.

CRSP is an exciting stock with a bright future. Analysts such as Oppenheimer, Jefferies, Chardan Capital, and Canaccord Genuity have assigned it a buy rating, and many independent analysts are bullish on the stock.

I too am bullish about its growth prospects but am not putting out a buy call at this price because the stock is extremely expensive.

Q2 2020, as discussed above, is likely to be adversely impacted, and there is no clarity on when the COVID-19 disruption will end. The companys product pipeline is likely to slow down as well.

Considering all positives and negatives, I would rely more on price action than news. The stock hit a low of about $33 in March 2020 and is priced at $73.09 as of June 25, 2020. I would start accumulating the stock in small quantities after it retraces 50% of its rise from its March lows, or approximately $53. I would buy small parcels at this price and keep adding on dips.

If suddenly there is clarity on when the virus disruption is going to end, or if its severity (in terms of morbidity) has greatly reduced, I would buy this stock at whatever rate it is available on that day.

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Crispr Therapeutics AG: Risks, Rewards, And Valuation - Seeking Alpha

Transparency Market Research (TMR) has published a new report titled, CRISPR and Cas GenesMarket Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20182026. According to the report, theglobal CRISPR and Cas genes marketwas valued at US$ 7,234.5 Mn by 2026, expanding at a CAGR of around 20.1% from 2018 to 2026. Increase in applications of CRISPR and Cas gene editing technology in bacteria and usage of gene editing technology for prevention of various diseases are the major factors anticipated to drive the market from 2018 to 2026. Rise in need of alternative medicine for chronic diseases and increase in investments by key players in Asia Pacific are projected to propel the market during the forecast period.

Get Brochure of the Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=26417

Increase in Usage of DNA-free Cas

DNA-free Cas9 is most commonly used with synthetic crRNA tracrRNA and chosen by researchers who strive to avoid unwanted vector DNA integration into their genomic DNA. CRISPR-Cas9 utilizing mRNA or protein is ideal for applications such as knocking of a fluorescent reporter using HDR or knockout cell line generation. Advantages such as gene editing with DNA-free CRISPR-Cas9 components to reduce potential off-targets and potential usage of CRISPR-Cas9 gene editing to find correlations with human diseases in model systems drive the segment.

Rise in Incidence of Genetic Disorders and Increase in Applications of CRISPR and Cas Genesto Propel Market

Genetic diseases are generally termed as rare diseases. According to NCBI, prevalence of these rare diseases is approximately 5 in 10,000. There are 6,000 to 8,000 rare diseases, with 250 to 280 new diseases diagnosed every year. Hence, 6% to 8% of the global population is projected to be affected by rare diseases i.e., genetic diseases in the near future. Researchers are developing treatments for these diseases with applications of new technologies such as CRISPR. The applications of CRISPR technology are expanding in other industrial sectors. This is expected to drive the market during the forecast period. Usage of CRISPR/Cas9 technology in plant research has enabled the investigation of plant biology in detail which has helped to create innovative applications in crop breeding. Site-directed mutagenesis and site-specific integration of a gene, which is also called knock-in, are important in precision crop breeding. Cas9/gRNA-mediated site-directed mutagenesis and knock-in is widely used in rice and Arabidopsis protoplasts. CRISPR/Cas9 provides a simple method to generate a DSB at a target site to trigger HDR repair.

Request For Covid19 Impact Analysis https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=26417

Ethical Issues Concerning Gene Editing Technology to Restrain Market

Any changes in the human genome are made in the germline, and hence are expected to be passed on to the future generations. The safety and efficacy concerns with genome editing have gained momentum with the discovery of CRISPR, as it has the potential to make accurate use of genome editing technologies. Major ethical issues concerning the human genome editing technology are disturbance of the ecological equilibrium, patent regulations concerning CRISPR/Cas9 gene technology, non-therapeutic interventions using human genome, and formation of chimera which has the risk of violation of the order of nature and giving rise to moral confusion for treating organisms.

Asia Pacific Market to Witness Exponential Growth

In terms of revenue, the CRISPR and Cas genes market in Asia Pacific is expected to expand at a CAGR of 22.0% during the forecast period. Growth of the market in the region can be attributed to increase in incidence of chronic diseases such as cancer and the need of development of genetic engineered treatment options. According to the report, Call for Action: Expanding Cancer Care for Women in India, 2017, an estimated 0.7 million women in India are suffering from cancer. China dominated the CRISPR and Cas genes market in Asia Pacific. In 2016, scientists based in China launched the first known human trials of CRISPR, the genomic tech that involves slicing and dicing the bodys very source code to fight cancer. Japan was the second largest market for CRISPR and Cas genes in Asia Pacific.

Read our Case study at :https://www.transparencymarketresearch.com/casestudies/innovative-medical-device-manufacturing-start-up

Addgene, Thermo Fisher Scientific, Inc., and Integrated DNA Technologies, Inc. to Lead Market

The report also provides profiles of leading players operating in the global CRISPR and Cas market such as Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

More Trending Reports by Transparency Market Research 1.https://www.prnewswire.com/news-releases/global-radiation-therapy-market-to-reach-us-8-6-bn-by-2026product-approvals-to-drive-growth-transparency-market-research-300998453.html

2.https://www.biospace.com/article/cholesterol-lowering-drugs-market-increase-in-prevalence-of-coronary-artery-disease-to-drive-market/

Here is the original post:
CRISPR and Cas Genes Market Share is Thriving Worldwide By Size, Revenue, Emerging Trends and Top Growing Companies 2026 - Science Examiner

On 27 June, Verve therapeutics, a US-based biotechnology firm, in a press release,announced that they have demonstrated, in primate models, the successful use of base-editing to switch off two genes in the liver to reduce blood LDL (low-density lipoproteins) and triglyceride levels. These two factors increase the risk of coronary atherosclerosis.

Coronary atherosclerosis or coronary artery disease refers to the development of plaque inside the coronary arteries (arteries that supply blood to the heart). This plaque narrows down the arteries, reducing blood flow. This leads to chest pain, lightheadedness and shortness of breath and increase in the risk of a heart attack.

Base-editors are CRISPR-based tools that can specifically make point mutations in the DNA of an organism. Mutations refer to changes in the DNA sequence. A mutation can switch on or off a gene or it can increase or decrease its functioning.

Representational image. Reuters

CRISPR-Cas9 system consists of two things - CRISPR, which are short palindromic sequences of DNA/RNA that help identify the target sequences and Cas 9, which is an enzyme that cuts the sequences that CRISPR identifies.

The results of the study were presented at the 2020 Virtual Annual Meeting of the International Society for Stem Cell Research (ISSCR).

The study

For the study, the researchers at Verve targetted and turned off (by giving an intravenous drug) one of the two genes in a group of 14 monkeys - PCSK9 (proprotein convertase subtilisin/Kexin type 9) or ANGPTL3 (angiopoietin-like protein 3). The former produces a protein that increases LDL levels in the blood while the latter produces a protein that increases blood-triglyceride rich lipoprotein levels.

Results were noted two weeks after delivering the drug. Here is what was found:

The future prospects

According to the World Health Organisation, cardiovascular diseases, including coronary artery disease, are the number one cause of death in the world, claiming about 17.9 million lives each year.

The condition is currently treated through a combination of lifestyle modifications and medications to control the symptoms and keep the disease from worsening. Surgery is often needed to remove the plaque.

Praising their new tool, Dr Andrew Bellinger, Chief Scientific Officer at Verve Therapeutics said in the press release that the fact that PCSK9 and ANGPTL3 can be silenced safely and effectively in non-human primates and that blood LDL and triglyceride levels can be reduced is very exciting.

He added that one of the most important things is that no other non-target gene was affected in the study and that this just proves that Verves once-and-done gene editing treatments may actually be effective in treating coronary artery disease in adults.

Since the genes are silenced, the person will not need to be on treatment for long. Verve is set to start the clinical phase of their study by 2023.

For more information, read our article on Heart Disease.

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

Original post:
Research on a gene-editing technique to treat heart disease shows promising results in animal trials - Firstpost

The Global Gene Therapies Market Research Report provides customers with a complete analytical study that provides all the details of key players such as company profile, product portfolio, capacity, price, cost, and revenue during the forecast period from 2020 to 2027. The report provides a full assessment. Gene Therapies market with future trends, current growth factors, meticulous opinions, facts, historical data and statistically supported and industry-validated market data.

This Gene Therapies market research provides a clear explanation of how this market will impress growth during the mentioned period. This study report scanned specific data for specific characteristics such as Type, Size, Application and End User. There are basic segments included in the segmentation analysis that are the result of SWOT analysis and PESTEL analysis.

To Learn More About This Report, Request a Sample Copy:https://www.worldwidemarketreports.com/sample/179400* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

Adaptimmune Therapeutics Plc., Celgene Corporation, Crispr Therapeutics Ag, Glaxosmithkline Plc, Intellia Therapeutics Inc., Merck & Co. Inc., Novartis Ag, Regenxbio Inc., Voyager Therapeutics Inc., Abeona Therapeutics Inc. are some of the major organizations dominating the global market.(*Note: Other Players Can be Added per Request)

Key players in the Gene Therapies market were identified through a second survey, and their market share was determined through a primary and second survey. All measurement sharing, splitting, and analysis were solved using a secondary source and a validated primary source. The Gene Therapies market report starts with a basic overview of the Industry Life Cycle, Definitions, Classifications, Applications, and Industry Chain Structure, and when used together, how key players can meet market coverage, offered characteristics, and customer needs It helps to understand.

The report also makes some important suggestions for new Gene Therapies market projects before evaluating their feasibility. Overall, this report covers Gene Therapies market Sales, Price, Sales, Gross Profit, Historical Growth,and Future Prospects. It provides facts related to the widespread merger, acquisition, partnership, and joint venture activities on the market.

This report includes market size estimates of value (million US $) and trading volume (K MT). The top-down and bottom-up approaches are used to estimate and validate the market size of the Gene Therapies market, estimating the size of various other subordinate markets in the overall market. All ratio sharing, splitting, and analysis were determined using the secondary source and the identified primary source.

What Gene Therapies Market report offers:

Remarkable Attributes of Gene Therapies Market Report:

About WMR

Worldwide Market Reports is your one-stop repository of detailed and in-depth market research reports compiled by an extensive list of publishers from across the globe. We offer reports across virtually all domains and an exhaustive list of sub-domains under the sun. The in-depth market analysis by some of the most vastly experienced analysts provide our diverse range of clients from across all industries with vital decision making insights to plan and align their market strategies in line with current market trends.

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Gene Therapies Market: Future Opportunities, Revenue Growth, Rating, and Profit (2020 2027): Adaptimmune Therapeutics Plc., Celgene Corporation,...

Japanese pharma and biotech friend Takeda is set to spend nearly $1 billion in backloaded payments for a deal with early-stage startup Carmine Therapeutics.

The pair will target rare diseases using gene therapies out of the biotechs red blood cell extracellular vesicles (RBCEVs) platform, which it calls Regent and was first published in Nature back in 2018 (with the startup officially launching a year later).

An initial focus is non-viral gene therapies rather than the traditional path of adeno-associated virus (AAV)-based gene therapies that can lead to unwanted side effects.

De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

There is a high attrition rate during the development of biotherapeutics impacting the high cost of development. Early identification of the preferred expression host for manufacturing, along with lead candidate screening and material supply can help to reduce both attrition rates and cost.

The biotech said its RBCEV-based gene therapy has the potential for repeat dosing, a significantly larger transgene payload capacity in excess of 11KB, and enhanced bio-distribution in selected tissues through RBCEV surface modification.

The deal could be worth as much as $900 million, with Takeda leading Carmine's convertible note seed plus funding round by extending a $5 million convertible loan to the biotech. Theres an upfront payment and extra research funding cash, though details of dollar amounts here were not given.

Takeda nabs an option to license the programs following the completion of preclinical proof of concept studies; from here, it would be responsible for clinical development and sales.

Carmine Therapeutics was founded last year by Esco Ventures X, a life science fund, professor Harvey Lodish of the Whitehead Institute at MIT and Singaporean professors Minh Le and Jiahai Shi.

Lodish was a founding member of several big biotechs, including Genzyme (which was snapped up by Sanofi).

XQ Lin, founding CEO of Carmine Therapeutics and managing partner of Esco Ventures, said: We are pleased to enter this collaboration with Takeda, a recognized global leader in rare disease therapies, slightly more than a year since Carmine was created and incubated by Esco Ventures X. This provides Carmine with significant funding to further develop our REGENT(TM) platform, and advance our wholly-owned programs.

This also marks another, albeit very early venture into gene therapies for Takeda. In April, German CRO-biotech hybrid Evotec allied with Takeda to expand into gene therapy research. The move saw Evotec establish a 20-person team in Austria, the focal point of Takedas gene therapy operation, and sign up to work on programs for its Japanese partner.

Takeda acquired a gene therapy center in Orth an der Donau, Austria, through its purchase of Shire, which picked up the site two years earlier in its takeover of Baxalta. Throughout the series of changes in ownership, which began when Baxter spun out Baxalta in 2014, a team at the site has worked on gene therapies.

At Takeda, we're expanding our foundation in gene therapy by establishing a network of innovative partners like Carmine Therapeutics who are pursuing non-viral vector approaches that could leapfrog today's technology, added Takeda's rare disease drug discovery unit head Madhu Natarajan.

Developing alternative gene therapy delivery vehicles like the REGENT platform that could address the challenges of AAV gene therapy is critical to one day delivering next-generation cures for rare diseases.

Excerpt from:
Takeda pens $900M biobucks pact with Carmine for non-viral gene therapy work - FierceBiotech

PARIS--(BUSINESS WIRE)-- Regulatory News:

Lysogene (Paris:LYS)(FR0013233475 LYS), a Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced that the company has entered into a collaborative research agreement with Yeda Research and Development Co Ltd, the commercial arm of the Weizmann Institute of Science.

The agreement involves collaboration between Lysogene and the lab of Prof. Anthony Futerman at the Weizmann Institute of Science, with the aim of developing a novel AAV gene therapy approach for neuronopathic Gaucher disease, Parkinson disease, and other diseases associated with mutations of the GBA1 gene. Under the terms of the agreement, Lysogene will provide expertise in AAV vector design and production, while the lab of Prof. Futerman will provide glucocerebrosidase variants with enhanced biological properties and conduct biological proof and concept studies. Lysogene has an exclusive option to license the program.

Ralph Laufer, Chief Scientific Officer at Lysogene said: We are thrilled to start this research collaboration with Prof. Futerman, a leading expert in the field of sphingolipid biology. The Weizmann Institute is one of the world's leading multidisciplinary research institutes, and the source of numerous groundbreaking medical discoveries and technological applications. Lysogene is developing gene therapy approaches for monogenic neurological disorders, including neuronopathic lysosomal storage diseases. This collaboration is a perfect fit with Lysogenes strategy, providing the opportunity to develop a novel therapy for a rare lysosomal disease, with the potential to expand into neurological diseases with much larger patient populations, such as Parkinson.

About Lysogene

Lysogene is a gene therapy company focused on the treatment of orphan diseases of the central nervous system (CNS). The company has built a unique capability to enable a safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene is also collaborating with an academic partner on a gene therapy approach for the treatment of Fragile X syndrome, a genetic disease related to autism. http://www.lysogene.com.

Forward Looking Statement

This press release may contain certain forward-looking statements, forecasts and estimates with respect to Lysogenes clinical trials, clinical trial data releases, clinical development plans, anticipated future activities and cash runway of Lysogene. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice, (ii) factors beyond the Companys control, (iii) clinical trial results, (iv) increased manufacturing costs and (v) potential claims on its products. These statements may include, without limitation, any statements preceded by, followed by or including words such as target, believe, expect, aim, intend, may, anticipate, estimate, plan, objective, project, will, can have, likely, should, would, could and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Companys control that could cause the Companys actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. A further list and description of these risks, uncertainties and other risks can be found in the Companys regulatory filings with the French Autorit des Marchs Financiers, including in the 2019 universal registration document, registered with the French Markets Authorities on April 30, 2020, under number D.20-0427, and future filings and reports by the Company. Furthermore, these forward-looking statements are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more forward-looking statements, no inference should be drawn that it will or will not make additional updates with respect to those or other forward-looking statements.

This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200630005931/en/

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Lysogene Announces a Research Collaboration With the Weizmann Institute of Science - BioSpace

The Global Cell and Gene Therapy Market Market Research Report 2020 published by Prophecy Market Insights is an all-inclusive business research study on the current state of the industry which analyzes innovative strategies for business growth and describes significant factors such as top developers/manufacturers, production value, key regions, and growth rate. Impact of Covid-19 pandemic on the market will be completely analyzed in this report and it will also quantify the impact of this pandemic on the market.

The research study encompasses an evaluation of the market, including growth rate, current scenario, and volume inflation prospects, based on DROT and Porters Five Forces analyses. The market study pitches light on the various factors that are projected to impact the overall market dynamics of the Global Cell and Gene Therapy Market market over the forecast period (2019-2029).

Regional Overview:

The survey report includes a vast investigation of the geographical scene of the Global Cell and Gene Therapy Market market, which is manifestly arranged into the localities. The report provides an analysis of regional market players operating in the specific market and outcomes related to the target market for more than 20 countries.

Australia, New Zealand, Rest of Asia-Pacific

The facts and data are represented in the Global Cell and Gene Therapy Market report using graphs, pie charts, tables, figures and graphical representations helping analyze worldwide key trends & statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

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The research report also focuses on global major leading industry players of Global Cell and Gene Therapy Market market report providing information such as company profiles, product picture and specification, R&D developments, distribution & production capacity, distribution channels, price, cost, revenue and contact information. The research report examines, legal policies, and competitive analysis between the leading and emerging and upcoming market trends.

Global Cell and Gene Therapy MarketMarket Key Companies:

The predictions mentioned in the Global Cell and Gene Therapy Market market report have been derived using proven research techniques, assumptions and methodologies. This market report states the overview, historical data along with size, share, growth, demand, and revenue of the global industry.

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Global Cell and Gene Therapy Market, By Distribution Channel Type:

Global Cell and Gene Therapy Market, By End-Users:

The report provides an in-depth analysis of the Global Cell and Gene Therapy Market market segments and highlights the latest trending segment and major innovations in the market. In addition to this, it states the impact of these segments on the growth of the market. Apart from key players analysis provoking business-related decisions that are usually backed by prevalent market conditions, we also do substantial analysis of market based on COVID-19 impact, detailed analysis on economic, health and financial structure.

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Global Cell and Gene Therapy Market Market: Revenue Growth and Applications Insights - Cole of Duty

The Global Gene Therapy Technologies Market Research Report provides customers with a complete analytical study that provides all the details of key players such as company profile, product portfolio, capacity, price, cost, and revenue during the forecast period from 2020 to 2027. The report provides a full assessment. Gene Therapy Technologies market with future trends, current growth factors, meticulous opinions, facts, historical data and statistically supported and industry-validated market data.

This Gene Therapy Technologies market research provides a clear explanation of how this market will impress growth during the mentioned period. This study report scanned specific data for specific characteristics such as Type, Size, Application and End User. There are basic segments included in the segmentation analysis that are the result of SWOT analysis and PESTEL analysis.

To Learn More About This Report, Request a Sample Copy:https://www.worldwidemarketreports.com/sample/116778* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

Bluebird bio, Adaptimmune, GlaxoSmithKline, Merck, Celgene, Shanghai Sunway Biotech, BioCancell, Shenzhen SiBiono GeneTech, SynerGene Therapeutics, OncoGenex Pharmaceuticals, Genelux Corporation, Cell Genesys, Advantagene, GenVec, BioCancell, Celgene, Epeius Biotechnologies, Introgen Therapeutics, Ziopharm Oncology are some of the major organizations dominating the global market.(*Note: Other Players Can be Added per Request)

Key players in the Gene Therapy Technologies market were identified through a second survey, and their market share was determined through a primary and second survey. All measurement sharing, splitting, and analysis were solved using a secondary source and a validated primary source. The Gene Therapy Technologies market report starts with a basic overview of the Industry Life Cycle, Definitions, Classifications, Applications, and Industry Chain Structure, and when used together, how key players can meet market coverage, offered characteristics, and customer needs It helps to understand.

The report also makes some important suggestions for new Gene Therapy Technologies market projects before evaluating their feasibility. Overall, this report covers Gene Therapy Technologies market Sales, Price, Sales, Gross Profit, Historical Growth,and Future Prospects. It provides facts related to the widespread merger, acquisition, partnership, and joint venture activities on the market.

This report includes market size estimates of value (million US $) and trading volume (K MT). The top-down and bottom-up approaches are used to estimate and validate the market size of the Gene Therapy Technologies market, estimating the size of various other subordinate markets in the overall market. All ratio sharing, splitting, and analysis were determined using the secondary source and the identified primary source.

What Gene Therapy Technologies Market report offers:

Remarkable Attributes of Gene Therapy Technologies Market Report:

About WMR

Worldwide Market Reports is your one-stop repository of detailed and in-depth market research reports compiled by an extensive list of publishers from across the globe. We offer reports across virtually all domains and an exhaustive list of sub-domains under the sun. The in-depth market analysis by some of the most vastly experienced analysts provide our diverse range of clients from across all industries with vital decision making insights to plan and align their market strategies in line with current market trends.

Contact Us:

Mr. ShahWorldwide Market ReportsSeattle, WA 98154,U.S.Email: [emailprotected]

Read more from the original source:
Gene Therapy Technologies Market 2020 by Latest Innovations, Emerging Technology and Top Key Players: Bluebird bio, Adaptimmune, GlaxoSmithKline -...

5pm on June 26, 2020 - Kawasaki/Japan: The Innovation Center of NanoMedicine (iCONM), the National Institute for Quantum Science and Technology (QST), and the University of Tokyo jointly announced that a reagent for the selective and safe coating of the liver sinusoidal walls to control the clearance of gene therapy drugs was successfully developed. The contents of this research will be published in Science Advances by the American Association for the Advancement of Science (AAAS) at 2:00 pm on June 26, east coast of the United States (Japan standard time: 3:00 am on 27th): A. Dirisala, S. Uchida, K. Toh, J. Li, S. Osawa, T. A. Tockary, X. Liu, S. Abbasi, K. Hayashi, Y. Mochida, S. Fukushima, H. Kinoh, K. Osada, Kazunori Kataoka, "Transient stealth coating of liver sinusoidal wall by anchoring two-armed PEG for retargeting nanomedicines".

Recently, gene therapies have been successively approved in Europe, US, and Japan, and are expected to provide novel therapeutic options for cancer, chronic diseases, acquired and inherited genetic disorders. Whilst this is promising, in reality, when gene therapy drugs are systemically administered to living organisms, they are rapidly eliminated and metabolized in the liver, thus impeding the delivery of a sufficient amount to the target organs and raising the toxicity concerns. This elimination by the liver is caused by the adsorption of the gene therapy drugs to the vascular wall of the liver sinusoid, which is an intrahepatic capillary. To overcome this issue, we conceived to selectively coat the liver sinusoidal wall using polyethylene glycol (PEG). However, a long-term coating may impair the normal physiological functions of the liver, and therefore the coating should be transient. In addition, coating needs to be selective for liver sinusoids, as coating the blood vessels throughout the body would not only cause adverse effects but also decrease the delivery amount of gene therapy drugs to target organs. Towards this end, we have developed a coating agent with two-armed PEG conjugated to positively charged oligolysine, which demonstrated the selective coating on the liver sinusoidal wall, the first-of-its-kind strategy in the world. Interestingly, the coating with two-armed PEG was excreted into bile within 6 hours after binding to sinusoidal walls, while the coating with single chain of linear PEG bound to oligolysine persisted in the walls for a long time. In this way, the precise molecular design was necessary to achieve a transient coating.

This coating was subsequently applied to boost the delivery efficacy of gene therapy drugs. Adeno-associated virus (AAV) is widely used for viral gene therapy drugs, and its serotype 8 (AAV8) targets myocardium and skeletal muscles. When AAV8 was administered after prior coating of two-armed PEG to the liver sinusoidal wall, the transfer of AAV8 to the liver was suppressed, and as a result, the gene transfer efficiency into the myocardium and skeletal muscles was improved by 2 to 4 times. This approach is promising for the treatment of muscular dystrophy. In addition, we expanded the use of our strategy to virus-free gene delivery systems, which allows more economically attractive and safe gene therapy. We have been working on non-viral gene therapy for malignant tumors using plasmid DNA-equipped smart nanomachine for over 10 years. When the coating agent was used for this system, the adsorption of nanomachines to the sinusoidal wall was suppressed, resulting in an approximately 10-fold improvement in DNA transfer efficiency to colon cancer. As described above, we have succeeded in boosting the activity of gene therapy drugs while ensuring safety by using the coating agent developed this time.

The above findings are summarized as follows:

- The coating agent with two-armed PEG selectively coated the liver sinusoid wall for several hours and was then excreted in the bile.

- The coating agent with single chain of linear PEG is not excreted in bile and coated the liver sinusoidal wall for more than 9 hours, which raises a safety concern.

- The coating agent with two-armed PEG had selectivity for the liver sinusoid wall, without coating the blood vessels in the connective tissues.

- The coating agent improved the gene transfer efficacy to the myocardium and skeletal muscles using the AAV vector by 2 to 4 times, and the gene transfer efficiency to colorectal cancer using DNA-loaded smart nanomachines by 10 times.

- As a result, our approach is expected to allow for improving the effect of gene therapy drugs and reducing their dose needed to obtain therapeutic outcome, which will lead to the reduction of medical cost and adverse event opportunities.

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In recent months, even as our attention has been focused on the coronavirus outbreak, there have been a slew of scientific breakthroughs in treating diseases that cause blindness.

Researchers at U.S.-based Editas Medicine EDIT, +3.85% and Ireland-based Allergan (now owned by AbbVie ABBV, +1.02% ) have administered CRISPR for the first time to a person with a genetic disease. This landmark treatment uses the CRISPR approach to a specific mutation in a gene linked to childhood blindness. The mutation affects the functioning of the light-sensing compartment of the eye, called the retina, and leads to loss of the light-sensing cells.

According to the World Health Organization, at least 2.2 billion people in the world have some form of visual impairment. In the United States, approximately 200,000 people suffer from inherited forms of retinal disease for which there is no cure. But things have started to change for good. We can now see light at the end of the tunnel.

I am an ophthalmology and visual sciences researcher, and am particularly interested in these advances because my laboratory is focusing on designing new and improved gene therapy approaches to treat inherited forms of blindness.

Gene therapy involves inserting the correct copy of a gene into cells that have a mistake in the genetic sequence of that gene, recovering the normal function of the protein in the cell. The eye is an ideal organ for testing new therapeutic approaches, including CRISPR. That is because the eye is the most exposed part of our brain and thus is easily accessible.

The second reason is that retinal tissue in the eye is shielded from the bodys defense mechanism, which would otherwise consider the injected material used in gene therapy as foreign and mount a defensive attack response. Such a response would destroy the benefits associated with the treatment.

In recent years, breakthrough gene therapy studies paved the way to the first-ever Food and Drug Administration-approved gene therapy drug, Luxturna TM, for a devastating childhood blindness disease, Leber congenital amaurosis Type 2. (Luxturna was developed by Spark Therapeutics and licensed to Novartis NVS, +0.84% NOVN, +0.47%. Spark Therapeutics has since been acquired by Roche ROG, +1.35% RHHBY, +1.70% .)

This form of Leber congenital amaurosis is caused by mutations in a gene that codes for a protein called RPE65. The protein participates in chemical reactions that are needed to detect light. The mutations lessen or eliminate the function of RPE65, which leads to our inability to detect light blindness.

The treatment method developed simultaneously by groups at University of Pennsylvania and at University College London and Moorefields Eye Hospital involved inserting a healthy copy of the mutated gene directly into the space between the retina and the retinal pigmented epithelium, the tissue located behind the retina where the chemical reactions takes place. This gene helped the retinal pigmented epithelium cell produce the missing protein that is dysfunctional in patients.

Although the treated eyes showed vision improvement, as measured by the patients ability to navigate an obstacle course at differing light levels, it is not a permanent fix. This is due to the lack of technologies that can fix the mutated genetic code in the DNA of the cells of the patient.

Lately, scientists have been developing a powerful new tool that is shifting biology and genetic engineering into the next phase. This breakthrough gene-editing technology, which is called CRISPR, enables researchers to directly edit the genetic code of cells in the eye and correct the mutation causing the disease.

Children suffering from the disease Leber congenital amaurosis Type 10 endure progressive vision loss beginning as early as one year old. This specific form of Leber congenital amaurosis is caused by a change to the DNA that affects the ability of the gene called CEP290 to make the complete protein. The loss of the CEP290 protein affects the survival and function of our light-sensing cells, called photoreceptors.

One treatment strategy is to deliver the full form of the CEP290 gene using a virus as the delivery vehicle. But the CEP290 gene is too big to be cargo for viruses. So another approach was needed. One strategy was to fix the mutation by using CRISPR.

The scientists at Editas Medicine first showed safety and proof of the concept of the CRISPR strategy in cells extracted from patient skin biopsy and in nonhuman primate animals.

These studies led to the formulation of the first-ever in human CRISPR gene therapeutic clinical trial. This Phase 1 and Phase 2 trial will eventually assess the safety and efficacy of the CRISPR therapy in 18 Leber congenital amaurosis Type 10 patients. The patients receive a dose of the therapy while under anesthesia when the retina surgeon uses a scope, needle and syringe to inject the CRISPR enzyme and nucleic acids into the back of the eye near the photoreceptors.

To make sure that the experiment is working and safe for the patients, the clinical trial has recruited people with late-stage disease and no hope of recovering their vision. The doctors are also injecting the CRISPR editing tools into only one eye.

An ongoing project in my laboratory focuses on designing a gene therapy approach for the same gene CEP290. Contrary to the CRISPR approach, which can target only a specific mutation at one time, my team is developing an approach that would work for all CEP290 mutations in Leber congenital amaurosis Type 10.

This approach involves using shorter yet functional forms of the CEP290 protein that can be delivered to the photoreceptors using the viruses approved for clinical use.

Gene therapy that involves CRISPR promises a permanent fix and a significantly reduced recovery period. A downside of the CRISPR approach is the possibility of an off-target effect in which another region of the cells DNA is edited, which could cause undesirable side effects, such as cancer. However, new and improved strategies have made such likelihood very low.

Although the CRISPR study is for a specific mutation in CEP290, I believe the use of CRISPR technology in the body to be exciting and a giant leap. I know this treatment is in an early phase, but it shows clear promise. In my mind, as well as the minds of many other scientists, CRISPR-mediated therapeutic innovation absolutely holds immense promise.

In another study just reported in the journal Science, German and Swiss scientists have developed a revolutionary technology, which enables mice and human retinas to detect infrared radiation. This ability could be useful for patients suffering from loss of photoreceptors and sight.

The researchers demonstrated this approach, inspired by the ability of snakes and bats to see heat, by endowing mice and postmortem human retinas with a protein that becomes active in response to heat. Infrared light is light emitted by warm objects that is beyond the visible spectrum.

The heat warms a specially engineered gold particle that the researchers introduced into the retina. This particle binds to the protein and helps it convert the heat signal into electrical signals that are then sent to the brain.

In the future, more research is needed to tweak the ability of the infrared sensitive proteins to different wave lengths of light that will also enhance the remaining vision.

This approach is still being tested in animals and in retinal tissue in the lab. But all approaches suggest that it might be possible to either restore, enhance or provide patients with forms of vision used by other species.

Hemant Khanna is an associate professor of ophthalmology at the University of Massachusetts Medical School. This was first published on The Conversation Gene therapy and CRISPR strategies for curing blindness (Yes, you read that right)

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How gene therapy and CRISPR are helping to cure blindness - MarketWatch

The report is an analytical representation of the assessment of prime growth factors and key growth challenges facing participants in the Independent Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market. With a valuable overview of available areas of opportunity, this study presents detailed information about the most lucrative growth pockets that the companies in market are recommended to capitalize on. Potential market entrants can gain insights on the most profitable growth opportunities that already exist in Independent Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market and those that are most likely to be appearing in market over the course of near term.

The global Independent Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market report evaluates various factors associated with growth, including pricing structure, production capabilities, demand-supply scenarios and profit margins. The entire research intelligence is based on an exhaustive primary industry research and in-depth proactive secondary research that aim to extract valued data points about Independent Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market. The resultant data enables report readers to position themselves as potential market entrants and devise growth strategies to meet short- and long-term business goals.

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By Market Players:BioRelianceRichter-HelmUniQureCobra BiologicsMassBiologicsOxford BioMedicaLonzaMolMedFinVectorFUJIFILM Diosynth BiotechnologiesBrammer Biobluebird bioAldevronSpark TherapeuticsVGXIBiovianEurogentecNovasepPlasmidFactoryCell and Gene Therapy CatapultVigene Biosciences

By TypeAAVAdenoviralLentiviralRetroviralPlasmid DNAOther Vectors

By ApplicationCancersInherited DisordersViral InfectionsOthers

Market segment by Regions/Countries, this report covers

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Table of Contents

Chapter1IndustryOverviewChapter2GlobalViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingCompetitionbyTypes,Applications,andTopRegionsandCountriesChapter3ProductionMarketAnalysisChapter4GlobalViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingSales,Consumption,Export,ImportbyRegions(2015-2020)Chapter5NorthAmericaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter6EastAsiaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter7EuropeViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter8SouthAsiaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter9SoutheastAsiaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter10MiddleEastViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter11AfricaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter12OceaniaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter13SouthAmericaViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketAnalysisChapter14CompanyProfilesandKeyFiguresinViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingBusinessChapter15GlobalViral Vectors, Non-Viral Vectors and Gene Therapy ManufacturingMarketForecast(2021-2026)Chapter16Conclusions

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Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Key Players, Industry Overview, Application and Analysis to 2020-2026 - 3rd...

Gene Therapy Market 2020: Latest Analysis

Chicago, United States:- The report titled Global Gene Therapy Market is one of the most comprehensive and important additions to Report Hive Research archive of market research studies. It offers detailed research and analysis of key aspects of the global Gene Therapy market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the global Gene Therapy market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the global Gene Therapy market is carefully analyzed and researched about by the market analysts.

Top Players of Gene Therapy Market are Studied: Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche Bio, Celladon, Vical, Advantagene

Download Free Sample PDF (including full TOC, Tables, and Figures) of Gene Therapy Market Research 2020-2026:- @

Global Gene Therapy Market is estimated to reach xxx million USD in 2020 and projected to grow at the CAGR of xx% during 2020-2026. According to the latest report added to the online repository of Report Hive Research the Gene Therapy market has witnessed an unprecedented growth till 2020. The extrapolated future growth is expected to continue at higher rates by 2026.

Our exploration specialists acutely ascertain the significant aspects of the global Gene Therapy market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Gene Therapy market situation. In this Gene Therapy report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Gene Therapy report comprises of primary and secondary data which is exemplified in the form of pie outlines, Gene Therapy tables, analytical figures, and reference diagrams. The Gene Therapy report is presented in an efficient way that involves basic dialect, basic Gene Therapy outline, agreements, and certain facts as per solace and comprehension.

Segmentation by Application: Cancer DiseasesMonogenic DiseasesInfectious DiseasesCardiovascular DiseasesOthers

Segmentation by Type: Ex vivoIn vivo

NOTE:Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Gene Therapy Market which would mention How the Covid-19 is Affecting the Gene Therapy Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Gene Therapy Players to Combat Covid-19 Impact.

The Essential Content Covered in the GlobalGene Therapy Market Report:

* Top Key Company Profiles.* Main Business and Rival Information* SWOT Analysis and PESTEL Analysis* Production, Sales, Revenue, Price and Gross Margin* Market Share and Size

The report provides a 6-year forecast (2020-2026) assessed based on how the Gene Therapy market is predicted to grow in major regions like USA, Europe, Japan, China, India, Southeast Asia, South America, South Africa, Others.

Key Questions Answered In this Report:

What is the overall market size in 2019? What will be the market growth during the forecast period i.e. 2020-2026?

Which region would have high demand for product in the upcoming years?

What are the factors driving the growth of the market?

Which sub-market will make the most significant contribution to the market?

What are the market opportunities for existing and entry-level players?

What are various long-term and short-term strategies adopted by the market players?

What are the key business strategies being adopted by new entrants in the Gene Therapy Market?

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Table of Contents

Market Overview: This is the first section of the report that includes an overview of the scope of products offered in the global Gene Therapy market, segments by product and application, and market size.

Market Competition by Player: Here, the report shows how the competition in the global Gene Therapy market is growing or decreasing based on deep analysis of market concentrate rate, competitive situations and trends, expansions, merger and acquisition deals, and other subjects. It also shows how different companies are progressing in the global Gene Therapy market in terms of revenue, production, sales, and market share.

Company Profiles and Sales Data: This part of the report is very important as it gives statistical as well as other types of analysis of leading manufacturers in the global Gene Therapy market. It assesses each and every player studied in the report on the basis of main business, gross margin, revenue, sales, price, competitors, manufacturing base, product specification, product application, and product category.

Market Status and Outlook by Region: The report studies the status and outlook of different regional markets such as Europe, North America, the MEA, Asia Pacific, and South America. All of the regional markets researched about in the report are examined based on price, gross margin, revenue, production, and sales. Here, the size and CAGR of the regional markets are also provided.

Market by Product: This section carefully analyzes all product segments of the global Gene Therapy market.

Market by Application: Here, various application segments of the global Gene Therapy market are taken into account for research study.

Market Forecast: It starts with revenue forecast and then continues with sales, sales growth rate, and revenue growth rate forecasts of the global Gene Therapy market. The forecasts are also provided taking into consideration product, application, and regional segments of the global Gene Therapy market.

Upstream Raw Materials: This section includes industrial chain analysis, manufacturing cost structure analysis, and key raw materials analysis of the global Gene Therapy market.

Marketing Strategy Analysis, Distributors: Here, the research study digs deep into behavior and other factors of downstream customers, distributors, development trends of marketing channels, and marketing channels such as indirect marketing and direct marketing.

Research Findings and Conclusion: This section is solely dedicated to the conclusion and findings of the research study on the global Gene Therapy market.

Appendix: This is the last section of the report that focuses on data sources, viz. primary and secondary sources, market breakdown and data triangulation, market size estimation, research programs and design, research approach and methodology, and the publishers disclaimer.

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COVID-19 impact on Gene Therapy Market Share, Size, Revenue, Gross Margin and Growth Rate Analysis 2020-2026

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Impact of Corona on Gene Therapy Market 2020 Global Industry Size, Future Growth By 2026 | Sangamo, Spark Therapeutics, Dimension Therapeutics - 3rd...

Genespire and the San Raffaele Telethon Institute for Gene Therapy announce publication in Nature Biotechnology on enhanced gene editing technique in hematopoietic stem cells

Italy, Milan, 30 June 2020: The San Raffaele Telethon Institute for Gene Therapy (SR-Tiget) and Genespire, a gene therapy company developing transformative therapies for genetic diseases, announce today the publication of data highlighting progress in the development of an improved targeted gene replacement technology in human hematopoietic stem cells (HSCs) in Nature Biotechnology.

The paper, entitled Efficient gene editing of human long-term hematopoietic stem cells validated by clonal tracking, outlines technology developed by Pr. Luigi Naldini and his team at SR-Tiget, which is included in the strategic alliance with Genespire. It shows increased homology directed recombination (HDR) efficiency in HSCs by forcing cell-cycle progression and transiently upregulating components of the HDR machinery. The findings are validated by clonal tracking of the edited HSCs in experimental transplantation models, which shows improved polyclonal engraftment by long-term repopulating HSCs.

People with genetic diseases affecting the hematopoietic lineage may benefit from corrective targeted gene therapy in HSCs. These cells are self renewing and can differentiate into all the cell types of the hematopoietic lineage, therefore providing the potential for a one-time therapy. As compared to standard gene replacement approaches, gene editing corrects the disease-causing mutation in situ, restoring both function and physiological expression control of the affected gene. In principle, this targeted strategy may fulfill the goal of precision medicine at the most stringent genetic level. Its realization in HSCs, however, has been hampered until now by low efficiency of HDR-driven repair, likely because of the quiescent state of the more primitive progenitors. Use of the improved gene editing technology developed by SR-Tiget has been shown to yield a greater percentage of gene-edited HSCs and increased clonality, or the number of modified cells transplanted and engrafted in the recipient. In a clinical setting this should lead to increased hematopoietic cells chimerism in the patient receiving the corrective HSC therapy, and could accelerate the hematopoietic recovery after conditioning and increase the size, long-term stability, and safety of the engineered cell graft.

This approach can be applied to genetic diseases originating in the hematopoietic lineage, including primary immune deficiencies (PIDs), a key area of focus for Genespire. Genespire will continue to work with SR-Tiget and apply this technology to its future pipeline of gene therapies.

Julia Berretta, Chief Executive Officer of Genespire, commented: The focus of Genespires alliance with SR-Tiget is to research and develop novel gene therapies, addressing severe diseases with high unmet medical need. We are pleased with the publication of these data in Nature Biotechnology, which provide valuable insights into this pioneering technology developed by SR-Tiget, and we look forward to our future work with them to translate cutting edge science into transformational therapies.

Professor Luigi Naldini, Director of SR-Tiget and scientific co-founder of Genespire, said Our findings elucidate and overcome two main biological barriers to efficient HDR-mediated gene editing in HSCs, and show by clonal tracking that our enhanced editing protocol preserves their multilineage and self-renewal capacity long term after serial transplant. We look forward to our future work with Genespire to explore its potential in primary immunodeficiencies.

The full publication details are below and can be accesed online here.

Efficient gene editing of human long-term hematopoietic stem cells validated by clonal tracking Samuele Ferrari, Aurelien Jacob, Stefano Beretta, Giulia Unali, Luisa Albano, Valentina Vavassori, Davide Cittaro, Dejan Lazarevic, Chiara Brombin, Federica Cugnata, Anna Kajaste-Rudnitski, Ivan Merelli, Pietro Genovese and Luigi Naldini

Enquiries:

About Genespire

Genespire is a biotechnology company focused on the development of transformative gene therapies for patients affected by genetic diseases, particularly primary immunodeficiencies and inherited metabolic diseases. Based in Milan, Italy, Genespire was founded in March 2020 by the gene therapy pioneer Prof. Luigi Naldini and Dr. Alessio Cantore, Fondazione Telethon and Ospedale San Raffaele. It is a spin-off of SR-Tiget, a world leading cell and gene therapy research institute and is backed by Sofinnova Partners. http://www.genespire.com

Story continues

About SR-Tiget

Based in Milan, Italy, the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) is a joint venture between the Ospedale San Raffaele and Fondazione Telethon. SR-Tiget was established in 1995 to perform research on gene transfer and cell transplantation and translate its results into clinical applications of gene and cell therapies for different genetic diseases. Over the years, the Institute has given a pioneering contribution to the field with relevant discoveries in vector design, gene transfer strategies, stem cell biology, identity and mechanism of action of innate immune cells. SR-Tiget has also established the resources and framework for translating these advances into novel experimental therapies and has implemented several successful gene therapy clinical trials for inherited immunodeficiencies, blood and storage disorders, which have already treated >115 patients and have led through collaboration with industrial partners to the filing and approval of novel advanced gene therapy medicines.

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Genespire and the San Raffaele Telethon Institute for Gene Therapy announce publication in Nature Biotechnology on enhanced gene editing technique in...

XconomyNational

A new playbook is needed to ensure consistent chemistry, manufacturing, and controls (CMC) reviews for gene therapy products, the lack of which is hindering the development of these products, asserted a top official at the US Food and Drug Administration .

Now is the time to get things right asserted Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, who spoke at a 15 June virtual Drug Information Association annual meeting session on how innovation can help overcome hurdles for these products.

The sessions moderator, Nancy Myers, president of Catalyst Healthcare Consultants, asked the panelists to describe some of their main CMC constriction points in developing gene therapy products, and to identify potential solutions. The other panelists were Karen Walker, the senior advisor for cell and gene therapy at Genentech, who formerly was at Novartis (NYSE: NVS) and worked on the development of Kymriah, and Michael Paglia, director of CMC for ElevateBio.

Myers said that there are two common types of roadblocks to getting gene therapy products through the development pipeline, and these are logistical and technical challenges. The logistical challenges are having a well-trained workforce, managing global distribution networks and ensuring products are transported in cold temperatures, while the technical challenges are ensuring the quality of the starting materials and scaling up production from the research site to commercial manufacturing.

Another roadblock is the lack of standards and lack of a regulatory framework for these products. Myers said that this is a new and growing field and companies are trying to lay the track as they are trying to drive the train down the track at the same time.

CONSISTENT CMC PLAYBOOK NEEDED

Myers first asked the panelists to discuss what they see as constriction points in manufacturing gene therapy products. In response, Marks said that a lack of consistent reviews is hindering their development.

It has become apparent over the last couple of months that, while we have excellent reviewers, it does happen that people can have differences of opinion. I think we will have to come around and have a clear playbook so that everyone gets the same advice especially as we have grown. I know that someone out there will say, we had two different CMC reviewers and two differences pieces of advice. I am not going to argue with that. That is an issue here. As we come to the post-COVID period we should to try to have more unity in what comes from our CMC reviews. I cannot say the problem is solved but the problem has been identified and is amenable to solutions.

He further noted that the lack of clear regulatory pathway for these products is a major roadblock in accelerating their development. We do not have the preclinical pathways set up and the clinical set up and the regulatory paradigm is yet to be fleshed out. Now is the ripe time to get things right.

Marks also noted some of the manufacturing challenges in the cell and gene therapy space: We are in a place where our current vectors are limiting what we can address in terms of our ability to product them on a very large scale, and what will probably take some years to get there. On the other hand, the piece that really interests me is how do we deal with hundreds and thousands of rare diseases that we cant address right now through the production of gene therapy products where we simply do not have the manufacturing capacity to be able to produce these products in a rapid manner because we just dont have the systems.

MORE ON WHY DEVICE-LIKE REVIEW COULD HELP

Marks expanded on an idea he had suggested in February, that reviews for gene therapies should be more aligned with the device model. (Also see Individualized Gene Therapy: US FDA Considering Device-Like Manufacturing Approval Process Pink Sheet, 28 Feb, 2020.)

It is becoming increasingly clear that for cell and gene therapies, the manufacturing is more like a device paradigm with continued innovations, he said. With a traditional drug you come up with a chemical process to make a small molecule and you are probably using the process similarly across the lifecycle, but you are not constantly finding ways to do things that fundamentally change the yield or quality of a product. Here we have issues that manufacturing changes can potentially change the product for the better.

He added that we have to find some balance here between the traditional drug manufacturing model of once and done to something that is asking you go through multiple cycles of a device every two to three years where you are changing the technology. With device cycles, you may have multiple generations of the device over years. With a device you can measure things nicely, with biologicals you cannot measure easily.

Walker concurred that these are not well-characterized products and so we need to invest heavily in Next Page

Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing and quality issues.

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FDA Official: New "Playbook" Needed for CMC Reviews of Gene Therapy Products - Xconomy

The strategy analysis on Global Gene Therapy for Rare Disease Market gives insights of market size, trends, share, growth, development plans, Investment Plan, cost structure and drivers analysis. With precise data covering all key aspects of the existing market, this report offers existing data of leading manufacturers. The Gene Therapy for Rare Disease market report covers marketing channels and market positioning to potential growth strategies, providing in-depth analysis for new competitors or exists competitors in the Gene Therapy for Rare Disease industry. The Report Gives Detail Analysis on Market concern Like Gene Therapy for Rare Disease Market share, CAGR Status, Market demand and up to date Market Trends with key Market segments. The report provides key statistics on the market status of the Gene Therapy for Rare Disease manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. Overall, the report provides an in-depth insight of Gene Therapy for Rare Disease market covering all important parameters.

Note: *The Download PDF brochure only consist of Table of Content, Research Framework, and Research Methodology.

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Global Gene Therapy for Rare Disease market 2020-2026: Competitive AnalysisThe Gene Therapy for Rare Disease market report designed to provide entry support, customer profile and M&As as well as go-to-market strategy support. We provide a detailed analysis of key players operating in the global Gene Therapy for Rare Disease market, including key players such as Kite Pharma, Inc. (Gilead Sciences, Inc.), Novartis International AG, Juno Therapeutics Inc. (Celgene Corporation), Bluebird Bio, Inc., Spark Therapeutics, Inc., uniQure N.V, Orchard Therapeutics Plc., PTC Therapeutics, Inc., and BioMarin Pharmaceutical Inc.

Scope of Gene Therapy for Rare Disease Market:

The Gene Therapy for Rare Disease market was valued at XX Million US$ in 2019 and is projected to reach XX Million US$ by 2024, at a CAGR of XX% during the forecast period. In this study, 2019 has been considered as the base year and 2020 to 2024 as the forecast period to estimate the market size for Gene Therapy for Rare Disease.

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Gene Therapy for Rare Disease Market which would mention How the Covid-19 is Affecting the Gene Therapy for Rare Disease Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Gene Therapy for Rare Disease Players to fight Covid-19 Impact.

The report also focuses on global major leading industry players of Global Gene Therapy for Rare Disease market providing information such as company profiles, product picture and specification, price, capacity, cost, production, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out. With tables and figures helping analyze worldwide Global Gene Therapy for Rare Disease market, this research provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market. In general, the research report is a compilation of key data with regards to the competitive landscape of this vertical and the multiple regions where the business has successfully established its position. The report provides detailed information regarding the major factors (drivers, restraints, opportunities, and challenges) influencing the growth of the Gene Therapy for Rare Disease market. The Gene Therapy for Rare Disease Market Report analyzes opportunities in the overall Gene Therapy for Rare Disease market for stakeholders by identifying the high growth segments.

The scope of the report is limited to the application of the type, and distribution channel. The regions considered in the scope of the report include North America Country (United States, Canada), South America, Asia Country (China, Japan, India, Korea), Europe Country (Germany, UK, France, Italy), Other Country (Middle East, Africa, GCC). This report presents the worldwide Gene Therapy for Rare Disease market size (value, production and consumption), splits the breakdown (data status 20152019 and forecast to 2024), by manufacturers, region, type and application.

Market segment by Type, the product can be split into:Product Type Segmentation: Epicel, IntegraIndustry Segmentation: Chemical, Cosmetic, Pharmaceutical

The Global Gene Therapy for Rare Disease Market report analyses the production of goods, supply, sales, and the current status of the market in a detailed manner. Furthermore, the report examines the production shares and market product sales, as well as the capacity, production capacity, trends in sales, cost analysis, and revenue generation. Several other factors such as import/export status, industrial statistics, demand and supply ratio, gross margin, and industry chain structure have also been studied in the Global Gene Therapy for Rare Disease Market report.

The report comprehends precise analytical information related to market forecasts for several upcoming years. The report also includes the particulars about the valuation of macro and microelements significant for the growth of already established Gene Therapy for Rare Disease Market contenders and emerging new companies. The report uses SWOT analysis for the growth assessment of the outstanding Gene Therapy for Rare Disease Market players. It also analyzes the most recent enhancements while estimating the expansion of the foremost Gene Therapy for Rare Disease Market players. Additionally, the key product category and segments along with sub-segments of the global Gene Therapy for Rare Disease Market are studied in the global Market research.

What Reports Provides

Full in-depth analysis of the parent market Important changes in market dynamics Segmentation details of the market Former, on-going, and projected market analysis in terms of volume and value Assessment of niche industry developments Market share analysis Key strategies of major players Emerging segments and regional markets Testimonials to companies in order to fortify their foothold in the market.

Further, in the research report, the following points are included along with an in-depth study of each point:

* Production Analysis Production is analyzed with respect to different regions, types, and applications. Here, the price analysis of various Market key players is also covered.* Sales and Revenue Analysis Both, sales and revenue are studied for the different regions of the global market. Another major aspect, price, which plays an important part in the revenue generation is also assessed in this section for the various regions.* Supply and Consumption In continuation of sales, this section studies the supply and consumption of the Market. This part also sheds light on the gap between supply and consumption. Import and export figures are also given in this part.* Other analyses Apart from the information, trade and distribution analysis for the Market, contact information of major manufacturers, suppliers and key consumers are also given. Also, SWOT analysis for new projects and feasibility analysis for new investment are included.

Reasons to Buy:

* Obtain the most up to date information available on the Gene Therapy for Rare Disease projects globally.* Identify growth segments and opportunities in the industry.* Facilitate decision-making on the basis of strong historical and outlook of Gene Therapy for Rare Disease data.* Develop business strategies with the help of specific insights about the planned and announced Gene Therapy for Rare Disease projects globally.* Keep abreast of key new-build Gene Therapy for Rare Disease projects globally.* Assess your competitors planned and Gene Therapy for Rare Disease projects and capacities.

Additionally, the report is joined by a vital examination of the Gene Therapy for Rare Disease marketplace considering progress, part commitments, and future market forecasts. Furthermore, it offers detailed data of vendors including the profile, specifications of a product, sales, applications, annual performance in the industry, investments, acquisitions and mergers, market size, revenue, market share, and more. The report also studies individual regional market size along with country-wise and region-wise market size during the forecast period. The report also understands the export and import, production, and consumption of every particular region holding the highest market share, market size, or CAGR.

Conclusively, This report will provide you a clear view of each and every fact of the market without a need to refer to any other research report or a data source. Our report will provide you with all the facts about the past, present, and future of the concerned Market.

Note: *The discount is offered on the Standard Price of the report.

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Gene Therapy for Rare Disease Market 2026: Global Demand, Key Players, Overview, Supply and Consumption Analysis - 3rd Watch News

The Global Gene Therapy Industry Market report by UpMarketResearch.com provides a detailed analysis of the area marketplace expanding; competitive landscape; global, regional, and country-level market size; impact market players; market growth analysis; market share; opportunities analysis; product launches; recent developments; sales analysis; segmentation growth; technological innovations; and value chain optimization. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report.

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Market Segmentation

The Global Gene Therapy Industry Market has been divided into product types, application, and regions. These segments provide accurate calculations and forecasts for sales in terms of volume and value. This analysis can help customers increase their business and take calculated decisions.

By Product Types,Type 1Type 2Type 3

By Applications,Application 1Application 2Application 3

By Regions and Countries,Asia Pacific: China, Japan, India, and Rest of Asia PacificEurope: Germany, the UK, France, and Rest of EuropeNorth America: The US, Mexico, and CanadaLatin America: Brazil and Rest of Latin AmericaMiddle East & Africa: GCC Countries and Rest of Middle East & Africa

The regional analysis segment is a highly comprehensive part of the report on the global Gene Therapy Industry market. This section offers information on the sales growth in these regions on a country-level Gene Therapy Industry market.

The historical and forecast information provided in the report span between 2018 and 2026. The report provides detailed volume analysis and region-wise market size analysis of the market.

Competitive Landscape of the Gene Therapy Industry Market

The chapter on competitive landscape provides information about key company overview, global presence, sales and revenue generated, market share, prices, and strategies used.

Major players in the global Gene Therapy Industry Market include company 1company 2company 3company 4company 5company 6company 7company 8company 9

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The Gene Therapy Industry Market Report Addresses:

The Report Provides:

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About UpMarketResearch:UpMarketResearch (https://www.upmarketresearch.com) is a leading distributor of market research report with more than 800+ global clients. As a market research company, we take pride in equipping our clients with insights and data that holds the power to truly make a difference to their business. Our mission is singular and well-defined we want to help our clients envisage their business environment so that they are able to make informed, strategic and therefore successful decisions for themselves.Contact Info UpMarketResearchName Alex MathewsEmail [emailprotected]Website https://www.upmarketresearch.comAddress 500 East E Street, Ontario, CA 91764, United States.

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Gene Therapy Industry Market Industry Perspective, Comprehensive Analysis, Size, Share, Growth, Segment, Trends And Forecast, 2025 - Cole of Duty

You dont go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Analyses to date have shown that 94% (34 out of 36 total trial participants) demonstrated overall immunological response rates based on preliminary data assessing humoral (binding and neutralizing) and T cell immune responses.

Moderna was criticized for its decision to sketch initial antibody responses which it said were at or above the level needed to guard against the pandemic at 2 doses over various times. But it provided a treasure of information compared to Inovios barebones explanation. The full data set, Inovio says, will be published later in a peer-reviewed journal. In the meantime, theyre largely leaving the data readout to the reader to decipher.

Also dangling bait to day traders:

A Phase II/III study should be set to go this summer, if regulators sign off. Plus, Operation Warp Speed the presidents initiative at achieving a vaccine rollout, around the election is including 4800 in a non-human primate study. And then there was the trusty mouse study, in which their vaccine prevented viral replication in rodent lungs after the tiny creatures were challenged with SARS-CoV-2.

Usually, that sort of release delivers a powerful if temporary surge in the share price. But this morning, Wall Street proved skeptical.

Inovios stock price slid 11% as some experienced observers called them out.

Inovios attempt to break out of the pack seemed to largely backfire this morning. When youre in a race involving AstraZeneca, Pfizer, Moderna, a host of Chinese companies, and many, many more, it seems the usual bait doesnt work so well.

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Positive Covid-19 vaccine data? New mouse study? OWS inclusion? Yep, but somehow, the usual tidbits from Inovio backfire - Endpoints News

DUBLIN, July 1, 2020 /PRNewswire/ -- The "Rare Disease Diagnostics: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.

The global rare disease diagnostics market should reach $26.7 billion by 2024 from $17 billion in 2019, rising at a CAGR of 9.5% over the forecast period.

The scope of the report includes rare disease diagnostic technologies, applications, industries, initiatives, patents and companies. The market for rare disease diagnostic products and services is given for 2018 and 2019, and then forecast through 2024.

This report reviews the main diagnostic technologies and explains why genetic variation is important in clinical testing and disease. It then discusses significant large-scale research initiatives that impact rare disease diagnostic applications. Of particular interest is a discussion of global population-scale sequencing projects and their likely impact in linking genetic variation to rare disease diagnostics. The main market driving forces for rare disease diagnostic products and services are listed and discussed.

The report categorizes and quantifies the rare disease diagnostics market by the disease category, technology platform, test purpose, analysis target and geography segments.

More than 95 companies in the rare disease diagnostic industry are profiled in this report.

The research also provides a summary of more than 50 of the main industry acquisitions and strategic alliances that took place from April 2018 through April 2020, including key alliance trends.

The report includes:

Market Insights

Rare diseases comprise a growing public health priority, as they affect upward of 300 million people globally and they are difficult to diagnose and treat.

There is a pressing need for better ways to detect and diagnose rare diseases, as well as to provide companion diagnostics for therapy guidance, clinical trials enrollment and therapy monitoring applications.

Better diagnostic tests for rare diseases can make significant differences in the lives of those affected by these conditions. Many rare diseases go undiagnosed for long periods of time because patients, families and physicians may have limited awareness of certain diseases, and the symptoms may not be informative to healthcare workers who may not have encountered such diseases before.

Extended time to diagnosis of a rare disease, along with so-called diagnostic odysseys, can lead to negative outcomes, including misdiagnosis or disease progression. Rapid, accurate diagnostics can significantly shorten these diagnostic odysseys.

In addition to early detection and diagnostic potential, rare disease therapeutics will be important in orphan drug development and use. Orphan drugs address rare disease patient populations, and they are expected to have a high growth rate through 2024. By 2024, orphan drugs may make up as much as one-fifth of global prescription sales. Rare disease diagnostics can be used to help physicians make proper decisions regarding which therapies to use and ways to monitor the efficacy of those therapies during treatment courses. Rare disease diagnostics can also be used to help select patients for orphan drug clinical trials.

More than 70% of rare diseases are inherited conditions, and they thus have genetic components, so this industry relies heavily on genetic analysis methods, including polymerase chain reaction (PCR), next-generation sequencing (NGS) and Sanger sequencing.

Key Topics Covered

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Overview

Chapter 4 Technology Background

Chapter 5 Rare Disease Diagnostics Initiatives

Chapter 6 Rare Disease Diagnostic Industries

Chapter 7 Rare Disease Diagnostics Strategic Alliances and Acquisitions

Chapter 8 Rare Disease Diagnostics Markets

Chapter 9 Rare Disease Diagnostics Patents and Intellectual Property

Chapter 10 Company Profiles

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Rare Disease Diagnostics Industry Anticipated to Reach $26.7 Billion by 2024 - Market Shares by Disease Class, Indication, Analysis Platform, Analysis...

The Gene Therapy Market Research Report 2020 published by Prophecy Market Insights is an all-inclusive business research study on the current state of the industry which analyzes innovative strategies for business growth and describes significant factors such as top developers/manufacturers, production value, key regions, and growth rate. Impact of Covid-19 pandemic on the market will be completely analyzed in this report and it will also quantify the impact of this pandemic on the market.

The research study encompasses an evaluation of the market, including growth rate, current scenario, and volume inflation prospects, based on DROT and Porters Five Forces analyses. The market study pitches light on the various factors that are projected to impact the overall market dynamics of the Gene Therapy market over the forecast period (2019-2029).

Regional Overview:

The survey report includes a vast investigation of the geographical scene of the Gene Therapy market, which is manifestly arranged into the localities. The report provides an analysis of regional market players operating in the specific market and outcomes related to the target market for more than 20 countries.

Australia, New Zealand, Rest of Asia-Pacific

The facts and data are represented in the Gene Therapy report using graphs, pie charts, tables, figures and graphical representations helping analyze worldwide key trends & statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

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The research report also focuses on global major leading industry players of Gene Therapy market report providing information such as company profiles, product picture and specification, R&D developments, distribution & production capacity, distribution channels, price, cost, revenue and contact information. The research report examines, legal policies, and competitive analysis between the leading and emerging and upcoming market trends.

Gene TherapyMarket Key Companies:

GlaxoSmithKline plc, Bluebird Bio, Inc., Adaptimmune Therapeutics plc, Celgene Corporation, Shanghai Sunway Biotech Co. Ltd., Merck KGaA, Transgene SA, and OncoGenex Pharmaceuticals, Inc.

The predictions mentioned in the Gene Therapy market report have been derived using proven research techniques, assumptions and methodologies. This market report states the overview, historical data along with size, share, growth, demand, and revenue of the global industry.

Segmentation Overview:

The report provides an in-depth analysis of the Gene Therapy market segments and highlights the latest trending segment and major innovations in the market. In addition to this, it states the impact of these segments on the growth of the market. Apart from key players analysis provoking business-related decisions that are usually backed by prevalent market conditions, we also do substantial analysis of market based on COVID-19 impact, detailed analysis on economic, health and financial structure.

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Gene Therapy Market: Predictable To Witness Sustainable Evolution over 2020-2030 - 3rd Watch News

Four more US biotechs filed to go public Friday as yet more companies clamber to get through a yawning IPO window and onto a market thats signaled its willingness to reward nearly any new drugmaker.

The new entrants are led by ALX Oncology and the biological analytics biotech Berkeley Lights, each of whom filed to raise $100 million. The autoimmune company Pandion Therapeutics also filed for $75 million, and Kiromic Biopharma, a tiny immuno-oncology startup based in San Antonio, filed for $25 million.

These companies will try to capitalize on a 2020 biotech IPO boom that the investment firm Renaissance Capital recently called historic. The spree began in January and, after a brief interlude when the pandemic first hit the US and Europe, has only picked up in the last two months. The 23 companies that have gone public averaged an 80% return on their offering price, according to Renaissance Capital numbers. Every single one priced above their midpoint or upsized their offering.

Unlike most of their fellow newly or would-be public biotechs, Berkeley Lights will enter the market with significant revenue on the books. The company doesnt make drugs but instead has built a digital cell biology platform that can analyze living cells from a variety of different dimensions and, in principal, accelerate drug development. Theyve partnered with Sanofi and Pfizer on antibody discovery and last year, signed a $150 million pact with Ginkgo Bioworks to help the synthetic biology unicorn advance its genetic engineering capabilities.

All told, the company earned $51 million in revenue last year. Unlike a drug developer, they have no cash earmarked for specific pipeline products, and said they will use proceeds for research, potential acquisitions and general corporate purposes.

For ALX Oncology, a successful offering would mean their second $100 million tranche of the year. In February, the California biotech raised $105 million to help advance its sole pipeline candidate: an antibody designed to target CD-47. Thats the same dont-eat-me signal targeted by Irv Weissmans Forty Seven Inc., the biotech Gilead paid $5 billion for in January. ALXs pitch is that their antibodys FC receptor is engineered to not attract macrophages, reducing toxicity. The biotech will use their proceeds to push the drug through its ongoinghead and neck squamous cell carcinomaand gastric cancer trial and begin new trials for it in acute myeloid leukemia and myelodysplastic syndrome. A portion is also earmarked for CMC work.

Founded out of Polaris in 2018, Pandion Therapeutics was tapped last year for an up-to $800 million partnership to help a reorganizing Astellas develop antibodies for auto-immune disorders. That deal included $45 million upfront and the company also earned $80 million from a Series B in April. The new funding will be used to push their lead molecule through Phase I/II trials in ulcerative colitis while also backing preclinical research, particularly on a pair of antibodies meant to turn on the PD-1 checkpoint and tamp down the immune system.

Kiromic, meanwhile, is in part just trying to stay alive. With less than $2 million 5 million when a subsequent $3 million Series B is included in the bank at years end, they acknowledged in their S-1 that theres substantial doubt regarding the Companys ability to continue as a going concern. In this climate, though, thats worked out just fine for other companies. Applied Molecular Transport went publicin May with the same concerns. They ultimately raised $177 million.

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The biotech IPO boom is becoming 'historic' as four more throw their hats in - Endpoints News

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotechs platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Its a fairly elegant but simple molecule, CEO Randy Schatzman told Endpoints News. Its basically an off-the-shelf therapeutic that physicians can call on to treat their patients without all the personalization and manufacturing difficulties that many of the I/O approaches have today.

The experimental drug is what Bolt calls an immune-stimulating antibody conjugate. Its based on a concept from Stanford immunologist Edgar Engleman, who invented the first cancer vaccine in Provenge, a treatment for prostate cancer. That vaccine involves a multi-step process where innate immune cells called dendrites are extracted, exposed to a protein from the patients own tumors (as you would expose the immune system to a viral or bacterial protein in a traditional vaccine) and then reinfused.

Bolts platform is designed to directly activate dendrites around tumors without the need for removal, treatment and re-infusion. The therapy is an antibody drug conjugate similar to those produced by Seattle Genetics, ADC Therapeutics, and Immunomedics, each of which contain an antibody to guide the therapy like a warhead to the tumor. The difference is that instead of strapping a chemical to the antibody that will kill cells in the area, Bolts drug has an agonist that will bind to receptors on the dendrites and activate them to attack the tumor.

If it works, the drug would turn the environment around the tumor from an immuno-suppressive to one that could not only kill the tumors once but prevent recurrence. Their first candidate usesa Herceptin biosimilar to target HER2, but in theory, Schatzman said, it should work with an antibody targeted at any oncogene and Bolt is exploring those options, both internally and with partnerships.

In February, five years after the companys foundation, they launched their first trial, putting the drug known as BDC-1001 into a Phase I/II trial for metastatic tumors that are HER2+, including gastric and breast cancer. That trial will test the drug both as a single-agent therapy and in combination with Mercks Keytruda. The idea is that activating the immune system in two different ways might make for a more effective treatment.

Despite some early concerns, Schatzman says, the company has not seen any delays in that trial from Covid-19.

After the first data emerge from the Phase I/II trial, the company will move into trials specifically for gastric and breast cancer, looking to see if it can not only clear cancers initially but also, by keeping the immune system on guard, ward off recurrence, an event that can come quickly for patients with these late-stage tumors.

Were going to see some quick answers in going past what is the current standard of care, Schatzman said. Id like to think it will take a long time to know where the end of this is, because in that sense, well have been very effective at treating these patients.

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Bolt Biotherapeutics nabs $93.5M to push Provenge inventor's new idea deeper in the clinic - Endpoints News

In 1987, people werent plugged in. There was no Reddit, no Twitter. This made the spread of information and with it, misinformation a much more difficult proposition. Pizzagate would have sounded like a Dominos giveaway, and even entertaining ideas like UFOs would make most of your friends think you were a crackpot. There were no basketball stars talking about their belief in the earth being flat; pop stars werent talking about chemtrails.

That was all before Unsolved Mysteries.

Long the stuff of shortwave radio and underground newsletters, conspiracy theories were made mainstream by the shows methodical storytelling, which revealed that the world is far stranger than we could ever imagine.

When Unsolved Mysteries first appeared on NBC over 30 years ago, it broke new ground with interactive television. TV audiences have often enjoyed weird tales, but did so from a distance. The Twilight Zone hypnotized viewers in the early 1960s with contemporary sci-fi parables narrated by Rod Serling. In the 1980s, Orson Welless narration of The Man Who Saw Tomorrow which dramatized the wild predictions of Nostradamus captivated audiences, even convincing swaths of Los Angeles residents that a giant earthquake would annihilate their city in 1988.

One especially noteworthy show, In Search Of, which ran from 1977-1982, examined all things paranormal as guided by the sage narration of Leonard Nimoy, less than a decade after his time on Star Trek. A disclaimer that the shows information was based in part on theory and conjecture fit the trippy feel of the narratives. The first episode of In Search Of considered if plants could communicate with people. Featured in the episode was Cleve Backster, who founded and led the CIAs interrogation section before starting his own school to train polygraph examiners. Backster believed that plants could feel pain and also claimed that the way yogurt bacteria responded to electrical stimulation proved they had the power of perception.

Nimoy, like a good Vulcan, narrated without judgment. The show featured on-site interviews and a soundtrack alternately dramatic and playful. No subject was off the table: Bigfoot, the Bermuda Triangle, ESP, the alien abductions, mysterious deaths of Marilyn Monroe and Amelia Earhart, Atlantis and cryonics. Decked in a turtleneck, Nimoy would offer a concluding summary to end each episode, his monologue grounded in a sense of wonder but low on certainty.

The New Age, ponderous feel of In Search Of was a product of its time. There is a movement easing across the land, Sara Davidson wrote in the 70s for Harpers magazine, a movement in which individuals are trying to work out personal salvation a way to proceed through life with harmony and peace, a minimum of tension, and a maximum of fulfillment. She documented a groundswell of interest in spiritual enlightenment that had moved from covert backroom sances to the suburbs. The open-minded era of that decade had been replaced by the more skeptical 80s. Viewers had enough fantasy; they wanted real life.

Before Unsolved Mysteries, creators Terry Dunn Meurer and John Cosgrovemade a trio of specials for NBC under the moniker Missing Have You Seen This Person? The programs depicted missing-persons cases, with a special focus on kidnapped children. After Raymond Burr and Karl Malden hosted the first three episodes of Unsolved Mysteries, the producers brought on Robert Stack. Already known to audiences as a respected actor for films like Written on the Wind and shows like The Untouchables, Stack felt more like an intrepid investigator than the esoteric Nemoy. Typically wearing a trench coat, Stack was serious but never stern, open-minded but not frivolous. And yes, he had a hell of a voice.

The seven specials of the first season of Unsolved Mysteries featured lost heirs, amnesia cases, missing treasure and unexplained deaths. One victim, Aileen Conway, was found in a burning car on an empty bridge road in Oklahoma. The cars heat was so intense, Stack narrates, that the heat was so intense that the car had actually melted into the metal guardrail into which it had crashed. Possibly even stranger was the scene at her home. The patio door was wide open. A garden hose dripped into their swimming pool. Her purse, with drivers license and glasses, was left on the floor. The iron was left on in the bedroom, the bathtub was full of water, and the phone was off the hook. This was different, darker fare than most of 1987 TV think Whos the Boss, Moonlighting and Night Court.

The series became weekly with its second season, and the show hit its stride. By offering a diverse range of four stories per episode, the show was able to appeal to viewers compelled by the real and the supernatural. One notable segment that captured a popular urban legend was the hunt for the infamous D.B. Cooper, who hijacked a Seattle-bound plane in 1971 before leaping and vanishing into the wilderness. Cooper probably didnt survive the fall, but there probably is just enough doubt to tempt the imagination.

The show depicted UFO sightings lights in the distance and close encounters along with kidnappings, murders, ghosts, long-lost family members and Satanic crimes. One early episode featured the tragic story of Kurt McFall, a high school student found half-naked and dead on a beach in the San Francisco Bay. McFall had joined the Society for Creative Anachronism, and would dress as a medieval knight for evening battles at an Oakland subway station parking lot. He soon became interested in more than just jousting: he apparently wanted to learn more about medieval religions, and befriended members of a local group. His father called it a Satanic cult, but one of its leaders who used the name Caradoc, an ancient Welsh moniker said McFall simply had an interest in magic. The group was likely part of the Feri tradition, a neo-pagan group started in the 1960s. But viewers in the late 1980s were hopped up on Satanic Panic, and McFalls strange death felt intensely evil.

Unsolved Mysteries suggested that we were always on the periphery of the unsafe. But it never felt overly moralizing; in fact, the show was often empathetic and genuine. One emblematic story was the disappearance of Patricia Meehan, a 37-year-old woman who caused a car accident in rural Circle, Montana. Dazed and silent, she got out of her car, walked down the road and climbed over a fencee before heading into a dark field. She was never seen again at least not officially. According to the show, Meehan had been spotted more than 100 times in Montana and Washington; this has since grown to over 5,000 alleged sightings. The show implied that Meehan might have amnesia, but like with other segments, refused to take a hardline stance so as to not influence viewers. Thats because the audience was the key to the success of Unsolved Mysteries. Although a disclaimer at the start of the show said, in part, that it was not a news broadcast, Unsolved Mysteries was something more: it was a chance to make things right.

A 1-800 number solicited tips, leads and ideas from viewers. An army of phone operators forwarded useful information to relevant authorities and family members. According to the producers, the show helped solve an impressive number of cases: more than 260 to date. Unsolved Mysteries set the interactive template for other shows, like Americas Most Wanted, which debuted in 1988, but focused on more conventional cases. Unsolved Mysteries embraced all things strange, and the weekly ritual of viewers sitting down to see and hear unusual stories had a curious result.

Unsolved Mysteries was quite literally a show from a different century. At first, the mysteries were culled from the newspaper reports. Campy transition screens announced the topics of different segments. There was the sublime eeriness of CCTV clips, odd ATM camera photos and dramatic recreations that themselves felt authentic in their blurriness. The score sounded like something out of a John Carpenter film. Even today, when you talk to people that came of age during the shows heyday, youll find people who recall it as a spookiest hour of television programming they were allowed to watch.

While the show retained a sizable viewership throughout its run, Unsolved Mysteries doesnt get enough credit for being so influential. In 1993, shortly after The X-Files premiered, creator and producer Chris Carter spoke with Cyberspace Vanguard, a sci-fi and fantasy zine. At the end of the long-forgotten interview, Carter says The X-Files is best understood as a cross between Silence of the Lambs and Unsolved Mysteries. The grainy, lo-fi look of the show is one that todays movie directors try to replicate. Even re-watching it in 2020, there is something slightly unsettling that you might not be able to put your finger on.

Unsolved Mysteries cultivated mainstream interest in conspiracy storytelling, creating the right mix for shows like The X-Files to thrive. It is difficult to imagine a character like Fox Mulder being so successful unless viewers were prepared to accept even the possibility that strangeness could be taken seriously.

The Stack era of Unsolved Mysteries ended in 2002, when he was diagnosed with prostate cancer. The show was briefly resurrected for Spike TV, but recycled and edited old segments rather than introducing new cases. Other shows followed in its footsteps, but none could capture its unique magic. In fact, the end of Unsolved Mysteries led to a fraying of conspiracy storytelling. One example is Conspiracy Theory With Jesse Ventura, which ran from 2009-2012, and was hosted by the titular former Minnesota governor. In that show, Ventura was center stage: he was a guy who was going to reveal the deepest government secrets to us. Channeling his old professional wrestling persona, Ventura brashly demanded answers, grilling politicians and government officials.

The series also showed how conspiracy thinking can go off the rails, as Ventura always tried to connect everything in some convoluted web of secrecy. The show grabbed big ratings for truTV, but Venturas knack for provocation caused real problems. One episode, Police State, was only shown once, after making some highly suspect intimations about FEMA and martial law. In one scene, Ventura quietly treks through the Georgia backwoods with none other than Alex Jones. The Infowars host takes Ventura to a clearing with stacks of long plastic containers, which he claims are coffins to be used in the event of mass, government-orchestrated extermination. In reality, the containers are standard-issue grave liners, but thats a less interesting story.

Conspiracy Theory, however entertaining, indulged in everything that Unsolved Mysteries avoided. It posited wild, multinational conspiracies, where its predecessor merely reveled in showing how discrete, unsolved events puncture holes into the fabric of our collective certainty about life. The theories provoked by Unsolved Mysteries were singular and narrow, the conspiracies of real-life tragedies and confusion, not unbridled fantasy.

Today, its hard to toggle through cable offerings at any hour of the day and not find shows dedicated to conspiracy theories, from the History Channel using cryptozoologists to talk about Bigfoot and the Loch Ness monster to shows unmasking secret societies like the Illuminati and the Bilderberg group. One of the most successful book franchises, Dan Browns Robert Langdon series, is based largely around biblical conspiracies. Jeffrey Epstein didnt kill himself has gone from conspiracy to meme to punchline. We live in conspiracy-obsessed times, and its no coincidence that Unsolved Mysteries was there at the dawn of it.

Now, the shows original creators are back for the Netflix reboot. Six episodes premiere on July 1, with six more to follow. Audience leads are solicited at the end of each episode.

The iconic theme song still hits. The new season shows us again how conspiracy thinking, at its most genuine, is connected to a sense of wonder about our world that we havent figured everything out. The format shift to one story per episode is perfect: we can now settle into often heartbreaking stories and reach a level of intimacy that was difficult in the past. The murder of a family, the disappearance of a mother and a likely hate-crime are all portrayed with technical skill and care. The shows production style is much sleeker, but its heart is earnest.

In 1990, Stack told the Los Angeles Times that the show tried to balance two needs: Were trying to produce theater and were trying to do a public service. The new Unsolved Mysteries made the right decision to not have a host, but the ghostly form of Robert Stack appears at the end of the opening credits implying that his presence still inspires the show. The old Unsolved Mysteries revealed how conspiracy theories make for great storytelling; the new version of the show demonstrates how such storytelling and thinking can be ambitious, responsible and maybe even necessary.

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How "Unsolved Mysteries" Raised a Generation of Conspiracy Theorists - InsideHook

Researchers have identified the source of a damaging immune reaction to acute psychological stress. The study revealed that proteins secreted in brown fat cells are responsible for triggering an inflammatory response to severe stress.

Cortisol is the primary hormone that is released during the bodys fight or flight stress response. It is a powerful anti-inflammatory hormone that reduces inflammation and regulates sugar and metabolism for the effective management of stress.

Since stress hormones like cortisol and adrenaline are designed to suppress the immune system and reduce inflammation, experts have struggled to understand why stress tends to escalate inflammatory issues like autoimmune diseases and rheumatoid arthritis.

In the clinic, we have all seen super-stressful events that make inflammatory disease worse, and that never made sense to us, said study co-author Dr. Andrew Wang of Yale University.

The scientists pinpointed an immune system cell, the cytokine interleukin-6 (IL-6), that triggers inflammation when the body is faced with psychological stress. Previous research has shown that IL-6, which is typically secreted in response to infections, plays a role in autoimmune diseases, cancer, obesity, diabetes, depression, and anxiety.

The researchers turned their attention to the relationship between IL-6 and stress after they observed elevated levels of the proteins in mice during a stressful procedure.

In a series of experiments with mice, the researchers found that IL-6 was induced by stress and worsened inflammatory responses. They were surprised to discover that IL-6 was secreted in brown fat cells, which are most notably involved in regulating metabolism and body temperature.

The team demonstrated that when signals from the brain to brown fat cells were blocked, stressful conditions had no effect on inflammatory responses.

The researchers identified an additional role of IL-6 in the bodys reaction to stress it helps prepare the body to increase glucose production in anticipation of threats.

Even after the metabolic production of glucose and the release of cortisol and adrenaline, IL-6 levels secreted by brown fat cells are at their peak. The researchers said this may explain why stress can trigger inflammation despite the presence of immune-suppressing hormones.

When IL-6 production was blocked in mice, they were less agitated when placed in a stressful environment. The experts suspect IL-6 may play a role in mental health disorders such as depression and anxiety.

According to Dr. Wang, many symptoms of depression such as loss of appetite and sex drive mimic those caused by infections like the flu. These so-called sickness behaviors can be triggered by IL-6.

Drugs that are designed to treat autoimmune diseases such as rheumatoid arthritis block the activity of IL-6. Preliminary findings suggest these drugs may help alleviate symptoms of depression, noted the researchers.

There is an ever-growing literature on the role of IL-6 outside of immunity, said study co-author Reina Desrouleaux. Our work is exciting because it contributes to shortening that gap of knowledge.

The study is published in the journal Cell.

By Chrissy Sexton, Earth.com Staff Writer

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Inflammatory response to stress linked to brown fat cells Earth.com - Earth.com

Weve all woken up covered in sweat at one point or another, especially on hot summer nights. But, if youve tried lowering your air conditioner, removing heavy blankets or adding a fan to your bedroom and you still wake up drenched, you might have night sweatsand it could signal a health issue that should be addressed sooner rather than later.

Night sweats, sometimes called nighttime hot flashes, dont mean you get hot while youre sleeping every now and then. Theyre repetitive, extreme and disrupt sleep, says Amy Zack, a family medicine physician at the Cleveland Clinic.

Its sort of a conventional name for an experience in which folks wake up soaked in sweat, she says. Its not just feeling hot, maybe if a room is hot or its warm outside, but rather sort of a drenching sweat that requires changing clothes, maybe changing bedclothes, as well.

Night sweats can be caused by a number of factors. If you have night sweats that disrupt your sleep, Zack says you need to talk to your doctor to rule out anything serious. Whenever we hear about somebody having soaking night sweats, it definitely requires a range of questions to determine what might be causing that, she says. Sleep disruption has a really big impact on all aspects of life.

Here are 10 possible causes of night sweats in women:

Common causes of night sweats for women are menopause and perimenopause, the stage leading up to menopause, when ovarian functions and menstrual cycles start to fluctuate, Zack says. Thats caused by hormonal fluctuation in the body, she explains. Its believed to affect the vascular system and result in a flushing and heat on the skin. When that happens, the body sweats to cool the skin down.

Night sweats and hot flashes during menopause can be treated with prescription medications and herbal supplements, such as ginseng or evening primrose oil.

Related:Kate Walsh on Menopause and What She Would Tell Her Younger Self

Night sweats can be a sign of a serious infection says Peter Bidey, vice chair of the Department of Family Medicine and assistant professor of family medicine at the Philadelphia College of Osteopathic Medicine.

Some of the infections that notoriously go along with night sweats are tuberculosis and HIV, he says, adding that endocarditis, an infection of the heart tissue, and osteomyelitis, infections of the bone, can also cause night sweats.

In these cases, treating the illness or infection may help night sweats go away.

Some cancers, like leukemia and Non-Hodgkins lymphoma, cause night sweats, Bidey says. And, night sweats can be an early sign of cancer, so its a good idea to visit your doctor for some tests.

Night sweats may also be a side effect of cancer treatments, including surgery, radiation therapy, hormone therapy, chemotherapy and some medications, according to the National Cancer Institute.

Anxiety, stress and depression, though mental health conditions, also impact the body physically, including raising the heart rate. Anytime you raise the heart rate can cause a feeling of anxiety, jitteriness, restlessness, and that can definitely make you feel sweaty, Zack says.

But, anxiety might not always cause the soaking night sweats that come with other conditions, she says.

Related:9 Ways to Keep Anxiety at Bay

Night sweats may be a side effect of certain medications, Bidey explains. Antidepressants, medications used to treat diabetes and hormone therapy drugs commonly have night sweats as a side effect.

For people with drug addiction, especially opioids, night sweats might also accompany drug withdrawal, Bidey adds.

Hyperthyroidism, or an overactive thyroid, causes excessive sweating, and sometimes night sweats.

Its generally less likely to be exclusively at night, Zack explains. It can change the body temperature and result in changes in metabolic rate that can cause sweating.

Treating the thyroid condition will usually help alleviate night sweats.

Any hormonal change may cause night sweats, especially for women, Zack says. That could include menopause, pregnancy, premenstrual syndrome or other hormonal shift.

Low testosterone in men may be another cause of night sweats.

Drinking alcohol raises your body temperature and can cause skin flushing. So, when you drink too much before bed, you may have night sweats. It disrupts sleep as well, Zack says. If you suspect your night sweats are alcohol-related, she suggests embracing a healthy lifestyle which includes healthy eating, exercise, and avoiding alcohol close to bedtime.

Related:What Does Recovery Mean Regarding Alcohol?

Night sweats are often a symptom of sleep apnea, the condition causing you to stop breathing while asleep (often several times a night), Bidey says.

Excessive sweating at night occurs three times more frequently in people with untreated obstructive sleep apnea, according to a 2013 study published in BMJ Open.

For people with hyperhidrosis, a condition that causes excessive sweating, night sweats are common.Its not only happening at night, though, Bidey says. Theyre overproducing sweat in certain areas of their body, sometimes their whole body. It happens during the day, too.

Medications, as well as some antiperspirants, Botox injections, laser treatment and iontophoresis are common treatments for hyperhidrosis, according to the International Hyperhidrosis Society.

The occasional sweaty night probably isnt cause for concern. Wearing loose-fitting clothing, opening a window, sleeping next to a fan, and avoiding alcohol, caffeine or spicy foods before bed will help, Bidey says.

But, if night sweats occur regularly and are so extreme that your clothing and bedclothes are soaked through, he suggests visiting your doctor.

Celebrity interviews, recipes and health tips delivered to yourinbox.

You dont want to chalk up night sweats to just being menopause or things along those lines, Bidey says. You want to take a deeper delve into it if necessary, which is where you want to bring in your primary care provider. Sometimes you could be missing a small cue or something, and it could be something thats more serious or underlying as a whole.

Stress, too, could be making you sweat more. Read more about how to stop stress sweating.

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What Causes Night Sweats? Causes of Night Sweats In Women - Parade

The research report on global Bone Marrow Transplant Rejection Treatment Market is a comprehensive guide for new market entrants. The report provides the market history of each product retailed by the company. It also provides a history of product types, technology and volume during the forecast period. The growth rate, challenges and obstacles are also explained in the Global Bone Marrow Transplant Rejection Treatment study report. The report highlights the rate of development of the strategies, products and technologies used in the production, manufacture and marketing of the product.

The following Top manufacturers are evaluated in this report: Bellicum Pharmaceuticals, Inc., Bio-Cancer Treatment International Limited, Biogen Inc, Boryung Pharmaceutical Co., Ltd., Bristol-Myers Squibb Company, Cantex Pharmaceuticals, Inc., Capricor Therapeutics, Inc., Cell Source, Inc., Cell2B S.A., CellECT Bio, Inc., Cleveland BioLabs, Inc., Compugen Ltd., Cynata Therapeutics Limited, Cytodyn Inc., Dompe Farmaceutici S.p.A., Dr. Falk Pharma GmbH, Escape Therapeutics, Inc., F. Hoffmann-La Roche Ltd., Fate Therapeutics, Inc., Generon (Shanghai) Corporation Ltd., Gilead Sciences, Inc., GlaxoSmithKline Plc, Idera Pharmaceuticals, Inc., & amp; More.

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Product Type CoverageAzathioprineAdrenocorticotropic HormoneCyclophosphamideCyclosporine AOthersApplication CoverageHospitalClinicOthers

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The Global Bone Marrow Transplant Rejection Treatment Market report analyzes the production of goods, supply, sales and the current state of the market in detail. In addition, the report examines the market share of production and sales of products, as well as capacity, production capacity, sales trends, cost analysis and revenue generation. Several other factors such as import / export status, industrial statistics, supply and demand ratio, gross margin and the structure of the industrial chain were also studied in the Global Bone Marrow Transplant Rejection Treatment Reports.

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What is the estimated market size of the Global Bone Marrow Transplant Rejection Treatment market? What are the effective growth drivers in the global Bone Marrow Transplant Rejection Treatment market? Who are the main manufacturers on the world market for Bone Marrow Transplant Rejection Treatment? What are the opportunities, risks, obstacles and challenges of the global Bone Marrow Transplant Rejection Treatment? What are the sales, revenues and price analysis of the main manufacturers on the world market? Who are the main traders, distributors and resellers on the world market ?

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To conclude, the Bone Marrow Transplant Rejection Treatment report mentions the key geographies, the market landscapes as well as the product price, revenues, volume, production, supply, demand, rate of market growth and forecasts etc. This report also provides a SWOT analysis, an investment feasibility analysis and a return on investment. analysis.

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Bone Marrow Transplant Rejection Treatment The market is booming worldwide | Bellicum Pharmaceuticals, Inc., Bio-Cancer Treatment International...