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Avid Bioservices and Aragen Bioscience Enter Agreement to Offer Biotechnology and Pharmaceutical Clients Integrated Solution for Cell Line and Process…

Posted: May 9, 2020 at 9:53 am

TUSTIN, Calif. and MORGAN HILL, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, and Aragen Bioscience, a leading contract research organization (CRO) focused on accelerating pre-clinical biologics product development, today announced a co-marketing agreement that will provide clients an integrated sequence-to-manufacturing service. Under terms of the non-exclusive agreement, the companies will offer customers Aragens cell line development expertise integrated with Avids upstream and downstream process development and analytical services to drive efficiencies and reduce overall timelines for delivering CGMP bulk drug substances.

With pharmaceutical and biotechnology companies focused on delivering their innovative medicines to patients as quickly as possible, this alliance aims to speed the entire CGMP manufacturing process by having a single, integrated team oversee a single, integrated project timeline with significant built-in process efficiencies, saidTimothy Compton, chief commercial officer of Avid. We view this collaboration with Aragen as a significant win for current and future clients of both companies and we are excited to contribute our deep CDMO expertise to the partnership, particularly our more than 15 years of commercial product manufacturing experience.

I am excited about this partnership that will enable us to accelerate drug development timelines and deliver new biologic therapeutics to patients faster by integrating two best-in-class offerings to our customers, said Axel Schleyer, CEO of Aragen. Our services in discovery, cell line development, which includes our innovative RapTr platform, protein production and preclinical testing are a great match with Avids clinical and commercial manufacturing capabilities. We look forward to this collaboration that advances novel ideas into breakthrough medicines.

AboutAvid Bioservices, Inc.

Avid Bioservicesis a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.www.avidbio.com

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products. http://www.aragenbio.com

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Avid Bioservices and Aragen Bioscience Enter Agreement to Offer Biotechnology and Pharmaceutical Clients Integrated Solution for Cell Line and Process...

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COVID-19 pandemic Agricultural Biotechnology Market 2019 | Growing Rapidly with Significant CAGR, Leading Players, Innovative Trends and Expected…

Posted: May 9, 2020 at 9:53 am

Research report on Agricultural Biotechnology Market size | Industry Segment by Applications, by Type, Regional Outlook, Market Demand, Latest Trends, Agricultural Biotechnology Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025. Analyzes current market size and upcoming 5 years growth of this industry.

Report Covers Global Industry Analysis, Size, Share, CAGR, Trends, Forecast And Business Opportunity.

Download Premium Sample Copy Of This Report: https://brandessenceresearch.biz/Request/Sample?ResearchPostId=166135&RequestType=Sample

Global Agricultural Biotechnology Market valued approximately USD XXX billion in 2016 is forecasted to grow with a healthy growth rate of more than XX% over the forecast period 2018-2025. The major factors speculated to augment the markets are growing population size, globally increasing transgenic crops demand due to increasing food requirements, rising per capita income. Agricultural biotechnology, also known as agritech, is an area of agricultural science that uses scientific tools and techniques, including genetic engineering, molecular markers, molecular diagnostics, vaccines, and tissue culture, to modify living organisms: plants, animals, and microorganisms.

The regional analysis of Global Agricultural Biotechnology Market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America region is the leading region across the world in terms of market share. Whereas, owing to countries viz. India, Indonesia, China, and Japan, the Asia Pacific region is expected to exhibit higher growth rate / CAGR over the forecast period 2018-2025.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Technology:Synthetic BiologyDeoxyribonucleic Acid (DNA) SequencingGenome Editing ToolsRibonucleic Acid (RNA) InterferenceBiochips

By Product:Crop Protection ProductsBiostimulantsBiopesticidesTransgenic SeedsCottonSoybeanFruits & vegetablesMaizeOthers

By Regions:North AmericaU.S.CanadaEuropeUKGermanyAsia PacificChinaIndiaJapanLatin AmericaBrazilMexicoRest of the World

Furthermore, years considered for the study are as follows:Historical year 2015, 2016Base year 2017Forecast period 2018 to 2025

The industry is seeming to be fairly competitive. Some of the leading market players include Bayer AG, Dowdupont Inc., Syngenta AG, BASF SE, Adama Agricultural Solutions Ltd., Certis USA LLC, Evogene Ltd., KWS SAAT SE, Monsanto Company, Vilmorin & CIE, and so on. The fierce competitiveness has made these players spend in product developments to improve the customers requirements.

Target Audience of the Agricultural Biotechnology Market Study:Key Consulting Companies & AdvisorsLarge, medium-sized, and small enterprisesVenture capitalistsValue-Added Resellers (VARs)Third-party knowledge providersInvestment bankersInvestors

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Table of Content:

Market Overview:The report begins with this section where product overview and highlights of product and application segments of the Global Agricultural Biotechnology Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company:Here, the competition in the Worldwide Global Agricultural Biotechnology Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the Global Agricultural Biotechnology Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the Global Agricultural Biotechnology Market.

Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the Global Agricultural Biotechnology Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User:This section of the research study shows how different end-user/application segments contribute to the Global Agricultural Biotechnology Market.

Market Forecast:Here, the report offers a complete forecast of the Global Agricultural Biotechnology Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

About Us:

We publish market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students.

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COVID-19 pandemic Agricultural Biotechnology Market 2019 | Growing Rapidly with Significant CAGR, Leading Players, Innovative Trends and Expected...

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Nanoparticles in Biotechnology and Pharmaceuticals Market Future Growth by In Depth Industry Analysis, Size, Trends and Forecast to 2026 – Cole of…

Posted: May 9, 2020 at 9:53 am

Shire

The scope of the Report:

The report analyzes the key opportunities, CAGR, and Y-o-Y growth rates to allow readers to understand all the qualitative and quantitative aspects of the Nanoparticles in Biotechnology and Pharmaceuticals market. A competition analysis is imperative in the Nanoparticles in Biotechnology and Pharmaceuticals market and the competition landscape serves this objective. A wide company overview, financials, recent developments, and long and short-term strategies adopted are par for the course. Various parameters have been taken into account while estimating market size. The revenue generated by the leading industry participants in the sales of Nanoparticles in Biotechnology and Pharmaceuticals across the world has been calculated through primary and secondary research. The Nanoparticles in Biotechnology and Pharmaceuticals Market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Highlights of the Nanoparticles in Biotechnology and Pharmaceuticals market study:

Speculations for sales:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Nanoparticles in Biotechnology and Pharmaceuticals market. Additionally, it includes a share of every segment of the Nanoparticles in Biotechnology and Pharmaceuticals market, giving methodical information about types and applications of the market.

Key point summary of the Nanoparticles in Biotechnology and Pharmaceuticals market report:

This report gives a forward-looking prospect of various factors driving or restraining market growth.

It presents an in-depth analysis of changing competition dynamics and puts you ahead of competitors.

It gives a six-year forecast evaluated on the basis of how the market is predicted to grow.

It assists in making informed business decisions by creating a pin-point analysis of market segments and by having complete insights of the Nanoparticles in Biotechnology and Pharmaceuticals market.

This report helps users in comprehending the key product segments and their future.

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Nanoparticles in Biotechnology and Pharmaceuticals market

Chapter 2: Evaluating the leading manufacturers of the global Nanoparticles in Biotechnology and Pharmaceuticals market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Nanoparticles in Biotechnology and Pharmaceuticals market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Finally, the report global Nanoparticles in Biotechnology and Pharmaceuticals market describes Nanoparticles in Biotechnology and Pharmaceuticals industry expansion game plan, the Nanoparticles in Biotechnology and Pharmaceuticals industry knowledge supply, appendix, analysis findings and the conclusion. It includes a through explanation of the cutting-edging technologies and investments being made to upgrade the existing ones.

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Verified Market Research also provides customization options to tailor the reports as per client requirements. This report can be personalized to cater to your research needs. Feel free to get in touch with our sales team, who will ensure that you get a report as per your needs.

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Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyse data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise and years of collective experience to produce informative and accurate research.

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Nanoparticles in Biotechnology and Pharmaceuticals Market Future Growth by In Depth Industry Analysis, Size, Trends and Forecast to 2026 - Cole of...

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Louis Bacon Is Having The Time Of His Life – Dealbreaker

Posted: May 9, 2020 at 9:50 am

When legendary hedge fund Louis Bacon returned his clients capital last year, possibly to avoid distraction from the destruction of his Bahamian neighbor and bte noire, he probably couldnt have known with certainty just how bad tings would get for Canadian discount fashion mogul Peter Nygard. Hed already seen their battle over tony Lyford Cay end in an arrest warrant for Nygard and the seizure of his impossibly garish and tasteless estate thereon. Since then, Bacons efforts to have Nygard exposed as a notorious sex criminal and human trafficker have exceeded beyond his wildest dreams: his company in bankruptcy and sold for parts; dozens of women alleging impossibly horrible assaults; and now a book to memorialize all of it and more.

Throughout the day, hed ask a particular girl if shed like to stay the night. If she said no? Ross alleged, Then theres always drugging. She even has alleged that Nygard went so far as to kill her family dog. The New York Times found that Nygard actually wired her $10,000 at one point, emailing Ross: I sent you money to buy a new dog..

I may be the only person in the world, he bragged, who has my own embryos growing in a petri dish.

One of his girlfriends, Suelyn Medeiros, wrote in her 2014 memoir about a trip she took with Nygard to Ukraine, where he was having stem cell research done.

He asked, Suelyn, do you know what the best stem cells are? she writes.

She did: Embryos.

Correct! she says Nygard responded. If you got pregnant and had an abortion, we could use those embryonic cells and have a lifes supply for all of us: you, your mother and me. A lot of people are doing it.

Well, if youre wondering just how much Bacon is enjoying all of this, why, take a look:

Billionaire investor Louis Bacons Moore Capital has gained 17 per cent so far this year, according to people familiar with the figures, which would rank it among the worlds best-performing hedge funds. Moores gains, which would rank among its biggest annual returns over the past decade, come as macro hedge funds enjoy a long-awaited revival.

Louis Bacons Moore Capital makes big gains after going it alone [FT]Fashion Mogul Peter Nygard Business Properties to Be Sold [WSJ]Canadian woman says fashion mogul Peter Nygard drugged and raped her in Bahamas [CBC]Inside the twisted world of rapist designer Peter Nygard: book [N.Y. Post]

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Avalon GloboCare advancing immune cell therapy to treat blood cancers using FLASH-CAR technology – Proactive Investors USA & Canada

Posted: May 9, 2020 at 9:50 am

The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patients own cells, as well as off-the-shelf cell therapy from a universal donor

(NASDAQ: AVCO) announced Friday that it is advancing its next-generation immune cell therapy to treat blood cancers using FLASH-CAR technology co-developed with strategic partner Arbele Limited.

The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patients own cells, as well as off-the-shelf cell therapy from a universal donor.

Currently, the Chimeric Antigen Receptor T (CAR-T) cellular immunotherapy platform is available. It involves a patients own T-cells a type of white blood cell that protects against infections and other diseases including cancer that are turned into personalized cancer-fighting cells.

The T-cells are removed from the patient, reprogrammed in the lab using a viral vector to target cancer cells, and infused back into the patient as a cancer immunotherapy.

But in contrast to these existing therapies, Avalon said its FLASH-CAR platform uses next-generation CAR technology to modify patients T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector.

Similar to T-cells, NK cells are a type of white blood cell, also able to attack cancer cells, but utilize different mechanisms. By using RNA molecules rather than a viral vector, Avalons RNA-based CAR technology is designed to rapidly create personalized CAR therapies in 1 to 2 days compared to the 10- to 14-day bio-manufacturing time necessary to generate currently available CAR-T cellular immunotherapy.

Avalon said its FLASH-CAR technology is also designed to reprogram the immune cells to hone in on multiple crucial cancer cell targets, called tumor antigens, to potentially achieve superior therapeutic effect. Avoiding the use of viral vectors and complicated bio-processing procedures significantly reduces manufacturing costs, resulting in a more affordable and potentially breakthrough therapy for cancer patients.

The FLASH-CAR technology can also be used to generate off-the-shelf,universal cell therapy that has the potential to reach even more patients.

Avalons first FLASH-CAR platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells.

Pre-clinical research on AVA-011, including tumor cytotoxicity studies, has been successfully completed and Avalon said it is immediately entering the process development stage to generate clinical-grade CAR-T and CAR-NK cells for use in human clinical trials.

Avalon and Arbele have jointly filed for US patents for this RNA-based CAR platform cellular therapy and for other applications.

Avalon expects to begin a first-in-human clinical trial with AVA-011 for the treatment of relapsed or refractory B-cell lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma in the first quarter of 2021. The goal is to use AVA-011 as a bridge to bone marrow stem cell transplant therapy, currently the only curative approach for patients with these blood cancers.

Avalon GloboCare is committed to decreasing the time it takes to deliver cellular immunotherapies to cancer patients, as well as lowering the cost of manufacturing by building on our unique RNA-based CAR platform that does not require using a viral vector, said CEO Dr David Jin.

We are accelerating our innovative discovery and development plan, as well as delivering precise clinical execution and leadership in cellular immunotherapy. Our pre-clinical studies are encouraging and we are excited for AVA-011 to enter the clinical development stage, including multi-center clinical trials following completion of process development to generate the cell therapy.

Arbele CEO John Luk added: Through this strategic partnership with Avalon GloboCare, we envision an accelerated scientific and clinical development of the RNA-based FLASH-CAR technology platform with great potential to generate 'off-the-shelf'immune effector cell therapies to treat both hematologic and solid malignancies.

Avalon, based in Freehold, New Jersey, specializes in developing cell-based technologies and is involved in the management of stem-cell banks and clinical laboratories.

The companys stock recently traded up 10% to $1.99a share in New York.

--UPDATES stock price--

Contact the author: [emailprotected]

Follow him on Twitter @PatrickMGraham

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Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M – Xconomy

Posted: May 9, 2020 at 9:50 am

XconomyNew York

Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group.

Stemline (NASDAQ: STML), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) targets CD123, a cell surface protein associated with the blood cancer.

The Menarini transaction is worth up to $677 million, according to the companies, which announced the agreement Monday. Under the deal terms Menarini, which is headquartered in Florence, plans to acquire Stemline shares at $12.50 apiece, split into $11.50 up front and another $1 upon the first sale of its drug in France, Germany, Italy, Spain or the United Kingdom following approval by the European Commissionas long as it occurs on or before the end of 2021.

Stemline requested European regulators review the drug as a treatment for adult BPDCN patients in January 2019, according to its latest annual report.

US sales of the drug brought in $43.2 million in 2019, its first year on the market. That year the company reported a net loss of $76.8 million.

Menarini CEO Elcin Barker Ergun, in a statement, said the acquisition would expand the Italian companys presence in the US and strengthen its oncology portfolio. The privately held biopharma says its annual sales top $4.2 billion.

As part of the Italian drug maker, Stemline plans to continue its efforts to launch the BPDCN drug outside of the US and to advance it as a potential treatment for other diseases. Stemline is also evaluating the drug in Phase 1/2 trials as a treatment for patients with chronic myelomonocytic leukemia, myelofibrosis, and acute myeloid leukemia.

Stemline saw its stock price soar on the acquisition announcement, rising to $12.10 in a jump of more than 150 percent compared to its close at $4.75 per share Friday. When Stemline went public in 2013, it priced its shares at $10 apiece.

Founded in 2003 by current CEO Ivan Bergstein, the companys approach to drug development is based on research into what are known as cancer stem cells, or cancerous cells that act like stem cells in that they reproduce themselves and sustain the cancer, showing outsize ability to resist chemotherapy and other standard cancer treatments. Read more about Stemlines origins in this Xconomy piece from 2011.

Both companies boards of directors have OKd the tie-up. If shareholders agree, the firms anticipate the deal will close this quarter.

Image: iStock/ChiccoDodiFC

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

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BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union – GlobeNewswire

Posted: May 9, 2020 at 9:50 am

NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today a lease agreement with the Tel Aviv Sourasky Medical Center (Sourasky)in Tel Aviv, Israel, to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the Companys capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Souraskys Institute for Advanced Cellular Therapies.

"Sourasky Hospital is a leader in the advancement and manufacturing of cell and gene therapy products and is well-equipped to rapidly scale up and produce NurOwn," stated Prof. Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We look forward to continuing our work with BrainStorm to bring NurOwn to ALS patients and help fulfill the clinical therapy demands for the Companys pipeline programs.

"Sourasky Hospital, known for introducing pioneering solutions into clinical practice and advancing patient care, has a first rate team with the proven experience to produce regenerative products in accordance to the highest standard of cGMP manufacturing," said Chaim Lebovits, CEO of BrainStorm. "This agreement will ensure that we can provide NurOwn to patients after regulatory approval, not only in Israel but we have secured capacity to rapidly scale up production as we advance our investigational treatment across the European Union. We are very pleased to be able to expand our ongoing collaboration with Sourasky Hospital, one of the worlds most innovative and respected medical centers."

About NurOwn NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union - GlobeNewswire

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Two New Research Institutes in the Bay Area – PRNewswire

Posted: May 9, 2020 at 9:50 am

The two institutes are an evolution of the former Gladstone Institute of Virology and Immunology, which was led by Warner Greene, MD, PhD, since its establishment in 1991 and made significant contributions to the fight against HIV/AIDS.

"As the joint Gladstone-UCSF search committee met with eminent scientists from around the globe to find a new director for the Gladstone Institute of Virology and Immunology, Melanie and Alex stood out as exceptional candidates in terms of their research accomplishments and their scientific vision," says Gladstone President Deepak Srivastava, MD, who chaired the search committee. "We realized they represent complementary, rather than alternative, directions for the future of Gladstone."

"They are both remarkable scientists," he adds. "We are honored to have them join our scientific leadership team and we look forward to the discoveries that will emerge from these new institutes."

The Gladstone Institute of Virology will focus on how viruses interface with human host cells to cause disease and how to intervene in that process. Ott's goal is to identify critical pathways that are common to human pathogenic viruses as a way to develop innovative treatments.

"Contrary to the current strategy of combining several drugs to treat one virus, we want to develop one drug against multiple viruses," says Ott, senior investigator at Gladstone and professor in the UCSF Department of Medicine. "As antibiotic resistance becomes an increasingly urgent problem, we will also delve into how we can use viruses as therapeutics, which involves using viruses against themselves or to fight bacteria."

Ott and her colleagues in the institute are concentrating their immediate efforts on the study of SARS-CoV-2, the virus that causes COVID-19. This work will continue to contribute important insights into the current pandemic through the development of rapid diagnostic, prevention, and treatment strategies, as well as help be better prepared for future coronavirus outbreaks and other emerging infections.

The Gladstone-UCSF Institute of Genomic Immunology will combine cutting-edge genomic technologies with gene editing and synthetic biology to better understand the genetic control of human immune cells and develop novel cell-based immunotherapies. Manipulation of the immune system holds great promise not only to treat cancer, but also for infectious diseases, autoimmune diseases, and maybe even neurologic conditions such as Alzheimer's disease.

"These rapidly advancing fields are starting to converge in ways that are too big for any single lab to take on," says Marson, senior investigator at Gladstone and associate professor in the Departments of Medicine and Microbiology and Immunology at the UCSF School of Medicine. "The impetus to start a new institute was the realization that we need to create an ecosystem to bring together people with different perspectives to think about transformative opportunities for how patients can be treated in the future."

Marson's institute will have lab space at Gladstone, adjacent to UCSF's Mission Bay campus, as well as at the University's Parnassus Heights campus, creating a unified community across the two campuses.

"The importance of pursuing advances in virology and immunology for human health has never been more clear, and we at UCSF applaud Gladstone's visionary leadership in establishing these two new institutes," says UCSF Chancellor Sam Hawgood, MBBS. "Under Melanie and Alex's excellent leadership, these research institutesincluding the first-ever Gladstone-UCSF institutewill complement and enhance UCSF's strengths in immunology and cell therapy, and will build on Gladstone's established expertise in the host-pathogen interface and gene editing technologies. Our long-standing partnership leverages the best of both institutions."

About the Search Committee

The joint Gladstone-UCSF search committee that recruited Melanie Ott and Alexander Marson was chaired byDeepak Srivastava. Other members included Katerina Akassoglou, Warner Greene, Todd McDevitt, Katherine Pollard, and Leor Weinberger from Gladstone, as well as Max Krummel, Susan Lynch, Tiffany Scharschmidt, Anita Sil, and Julie Zikherman from UCSF.

About Melanie Ott

A native of Germany, Melanie Ott, MD, PhD,is the director of the Gladstone Institute of Virology, a senior investigator at Gladstone Institutes, and a professor of medicine at UCSF.

Ott is passionate about using viruses to find fundamental new biology in host cells. She has made important discoveries about how virusesincluding the hepatitis C virus and Zikahijack human cells, and has contributed to efforts to eradicate HIV by gaining insight into viral transcriptional control. Since the outbreak of the COVID-19 pandemic, she pivoted the focus of her team and spearheaded the effort to establish a dedicated airborne pathogen BSL-3 lab to enable work on live SARS-CoV-2.

Prior to joining Gladstone in 2002, Ott started her own research group at the German Cancer Research Center in Heidelberg, Germany, working closely with Nobel laureate Harald zur Hausen. She is a trained neurologist with an MD from the University of Frankfurt/Main in Germany. She transitioned to basic virology research during the AIDS crisis, earning a PhD in molecular medicine from the Elmezzi Graduate School in Manhasset, New York.

Ott has received several honors, including the Young Researcher Award at the European Conference on Experimental AIDS Research and the Hellman Award. She is a member of the Association of American Physicians and a Fellow of the American Academy of Microbiology. She is a recipient of the Chancellor's Award for Public Service from UCSF for her work as the founder and co-chair of the student outreach committee at Gladstone. Ott also received the California Life Sciences Association's Biotechnology Educator Pantheon Award for establishing thePUMAS (Promoting Underrepresented Minorities Advancing in the Sciences) internship programat Gladstone, which seeks to increase diversity in STEM.

About Alexander Marson

Alexander Marson, MD, PhD,is the director of the Gladstone-UCSF Institute of Genomic Immunology, a senior investigator at Gladstone Institutes, and an associate professor in the Departments of Medicine and Microbiology and Immunology at UCSF.

Marson is interested in how DNA controls the behavior of cells in the human immune system. He uses the power of CRISPR technology to genetically engineer cells to fight cancer, autoimmune diseases, and infectious diseases.

He completed his undergraduate studies at Harvard University, and earned an MPhil in biological sciencesfromCambridge. He earned his PhD at Whitehead Institute at MIT, where he worked with mentors Rick Young and Rudolf Jaenisch on transcriptional control of regulatory T cells and embryonic stem cells.

After completing his MD at Harvard Medical School and an internship and residency at the Brigham and Women's Hospital, Marson joined UCSF in 2012 to complete clinical work as an infectious diseases fellow. He started his lab as a Sandler Faculty Fellow, before joining the faculty at UCSF and becoming scientific director of biomedicine at the Innovative Genomics Institute. He is also a Chan Zuckerberg Biohub Investigator and member of the Parker Institute for Cancer Immunotherapy.

About Gladstone Institutes

To ensure our work does the greatest good, Gladstone Institutes focuses on conditions with profound medical, economic, and social impactunsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with the University of California, San Francisco.

About UCSF

The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.UCSF Health, which serves as UCSF's primary academic medical center,includestop-ranked specialty hospitalsand other clinical programs, and has affiliations throughout the Bay Area. Learn more atucsf.edu, or see ourFact Sheet.

Sources

Gladstone Institutes: Megan McDevitt | [emailprotected] | 415.734.2019

UCSF: Pete Farley |[emailprotected] | 415.502.4608

SOURCE Gladstone Institutes

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A chance to change our harmful habits of eating and abusing animals – Seattle Times

Posted: May 9, 2020 at 9:50 am

Things have certainly changed this year for humans and other animals. Some of those changes will stick and be good for us all; others wont.

The live-animal markets in China, widely thought to be the source of the novel coronavirus, closed temporarily but are now reopening and, like those in the rest of Asia and even Europe and the U.S., are cause for alarm because they are breeding grounds for zoonotic diseases that can have fatal consequences for our own species.

On the good-news front, if you care about animals, those subjected to the annual Houston Livestock Show and Rodeo were granted a reprieve when it was canceled; horses got a break when racetracks closed (coincidentally just after a scandal erupted and trainers and owners were indicted on a charge of felony doping); Spain banned bullfights; and even that drunken melee known as the Running of the Bulls is likely not to take place this year. Lions have come out to lie on the now-deserted, usually tourist-infested Kenyan park roads; elk herds have been playing in the surf along the Oregon coast; and deer have returned to graze on lawns that were once their ancestral homes.

Some university laboratories decided that their work was no longer essential and adopted out or euthanized animals ordinarily used in experiments. Those of us who work to modernize research suggested that new shipments of animals should not replace them when the pandemic is over, as we now have human organs-on-a-chip and so many other technological advances that sticking an electrode into a dogs brain or a syringe full of chemicals down a rats throat is simply crude and cruel. After all, at Cedars-Sinai Hospital in Los Angeles, researchers use human pluripotent stem cells, an in vitro technique, to test the effects of chemicals found in household items like cookware and paint. Even high school dissection, for which 10 million live frogs, cats, pigs, turtles and others are killed every year nationwide, is being replaced with a simulated frog and computer software that replicates dissection without harming any living being.

People hoarded, but not just toilet paper. Since dairy milk requires refrigeration but almond, soy, rice, oat, and nut milks do not, shoppers began stocking up on nondairy milk, and as a result, cows and their beloved calves, who are torn away shortly after birth, may not suffer as much in the dairy industry. Some percentage of these consumers will no doubt stick with their newfound, healthier dairy alternative. They may also discover that companies like Miyokos Creamery, Kite Hill and Daiya make extraordinarily delicious plant-based cheeses, and in the world of ice cream, so many nondairy varieties now exist that you could fill a freezer with them and not have enough room for the rest.

Although some slaughterhouses have reopened, their temporary closures shed light on the abysmal working conditions inside them. Meanwhile, meat taste-alike products, such as Beyond Burgers, flew off the shelves, and consumers returned to staples like pasta with tomato sauce, rice and beans, baked potatoes, and vegetable soups and stews. People for the Ethical Treatment of Animals and others not only picketed the slaughter facilities with signs reading, Stay Closed Forever. Meat Kills, but also offered free vegan starter kits, recipes and tips for anyone who decided to use their lockdown time to try a vegan diet. In Seattle, the food technology startup Rebellyous recently took over a building that had previously housed a meat-processing facility and plans to use it to set up a prototype of a plant-based poultry factory.

Last year, global enforcement agencies conducted the most wide-ranging wildlife crime sting ever. This year, with reports damning the capture and farming of crocodiles and alligators for the fashion business and the threat of disease transmission from exotic species to our own, the trade will likely take a lasting hit. Clothing is rapidly undergoing change. Instead of using skinned animals, major designers have switched to synthetic and natural, sustainable fabrics. Some, like Cathryn Wills of Sans Beast and Matt & Nat have sworn off all types of leather. Car manufacturers like BMW, Lexus and Tesla now offer vegan leather and fabric interiors.

New York City is one of two states that banned foie gras last year, and in the last month, legislation has also been introduced there seeking to ban wet markets, where chickens, rabbits, turtles, ducks and other animals are caged and butchered, with their waste and blood covering the floors on which people tread as they make their way to their homes, offices and schools. May it pass for all our sakes.

In 2019, we took a step forward to help animals and our planet in many areas. If we reflect upon the opportunities we have to temper our harmful consumer habits, 2020 will see us taking more. So much depends on our acceptance of personal responsibility: We can make kind choices in everything we eat, wear, buy and do to entertain ourselves. We can demonstrate that we care about ending needless violence, show respect and consideration for all and live as if life truly counts by rejecting speciesism and affording all animals the care and compassion they deserve.

Ingrid Newkirk is the founder and president of PETA (People for the Ethical Treatment of Animals), which celebrates its 40th anniversary this year. She is the author of "Animalkind: Remarkable Discoveries about Animals and Revolutionary New Ways to Show Them Compassion," and other acclaimed books.

Gene Stone is the bestselling author, co-author or ghost writer of more than 45 books on a wide variety of subjects, including "Animalkind," "Forks Over Knives," and "How Not to Die, Living the Farm Sanctuary Life."

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Cancer Patients With COVID-19 May Have Higher Risk of Severe Illness and Death – Cancer Health Treatment News

Posted: May 9, 2020 at 9:50 am

People with cancer who contract the new coronavirus appear to have a greater risk for severe COVID-19 illness and death, but this may depend on their cancer stage and the type of treatment they are receiving, according to recent research. In fact, those with early-stage cancer may fare as well as people who have not had cancer.

Researchers from some of the earliest and hardest hit epicenters of the COVID-19 pandemic described outcomes among cancer patients with the coronavirus (officially known as SARS-CoV-2) during a special session the American Association for Cancer Research (AACR) virtual annual meeting last week. Soon after the conference, another group of researchers published an analysis of mortality among cancer patients in New York City.

Early reports from China, where the pandemic originated in late December, showed that older people, those with compromised immune systems and those with underlying health conditions are more susceptible to severe COVID-19. One study saw a death rate of 6% for people with cancermore than twice as high as the overall estimated COVID-19 mortality rate in China, but lower than the rates seen in people with diabetes (7%) or cardiovascular disease (11%).

Chemotherapy medications and some targeted therapies for cancer can cause neutropenia, a temporary depletion of immune system white blood cells that fight infection. People who receive bone marrow stem cell transplants or CAR-T therapy or for blood cancers typically receive strong chemotherapy to kill off existing blood cells and make room for the new ones. Conversely, immunotherapies such as checkpoint inhibitors and CAR-T therapy unleash natural or engineered T cells to fight cancer, which in some cases can trigger an excessive immune response that leads to harmful inflammation.

Two reports at the AACR meeting provided updates from China. Li Zhang, MD, PhD, of Tongji Medical College described outcomes among 28 cancer patients with COVID-19 in Wuhan, the initial epicenter of the pandemic.

Seven had lung cancer and the remainder had 13 other cancer types. Just over a third had Stage IV, or metastatic, cancer. Nearly 30% acquired the coronavirus at medical facilities. About half had severe disease, 10 patients required mechanical ventilators and eight diedmostly from acute respiratory distress syndromegiving a mortality rate of 29%.

Although three quarters had ever undergone surgery, radiation or chemotherapy, a majority had not received treatment recently. Only one person received radiation, three received chemotherapy, two received targeted therapy and one received immunotherapy within two weeks prior to their COVID-19 diagnosis. Recent cancer treatment was associated with a fourfold increased risk of severe outcomes. However, the single patient treated with a checkpoint inhibitor (for liver cancer) had mild COVID-19 and a short hospital stay.

Similarly, as part of his discussion of immunotherapy for cancer in the COVID-19 era, Paolo Ascierto, MD, of the National Tumor Institute in Naples, noted that just two out of 400 patients on immunotherapy at his institute tested positive for the coronavirus, they were asymptomatic and they recovered quickly, leading him to speculate that immunotherapy might somehow be protective against COVID-19.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University, presented data on 105 cancer patients and 536 age-matched people without cancer at 14 hospitals in Hubei province who developed COVID-19. Results were also published in Cancer Discovery. Twenty-two had lung cancer, 13 had gastrointestinal cancers, 11 each had breast cancer and thyroid cancer, nine had blood cancers such as leukemia or lymphomawhich affect white blood cells that carry out immune responsesand six each had cervical and esophageal cancer.

In general, patients with cancer deteriorated more rapidly than those without cancer, Cais team reported. Cancer patients with COVID-19 were nearly three times more likely to have severe or critical illness (34%), be admitted to an intensive care unit ICU (19%) or be put on a ventilator (10%). Whats more, people with cancer were about twice as likely to die as COVID-19 patients without cancer (11% versus 5%, respectively).

People with blood cancers or lung cancer, as well as those with metastatic cancer, had a higher risk of severe events. Two thirds of the blood cancer patients and half of the lung cancer patients had such events. Among the lung cancer patients, 18% were put on ventilators and 18% died. In contrast, no one with breast, thyroid or cervical cancer required ventilators or died.

In particular, those with blood cancersmore than half of whom had severe immune suppressionhad about a 10-fold higher risk of severe events or death. Two thirds had severe symptoms, 22% were put on ventilators and 33% died. These patients all had a rapidly deteriorated clinical course once infected with COVID-19, the researchers wrote.

People with metastatic cancer had about a six-fold higher risk of severe events or death. But people whose cancer had not yet spread were not significantly more likely to have severe events or die than COVID-19 patients without cancer. People currently on cancer treatment and those with a history of cancer who had completed treatment were both at higher risk.

People who underwent surgery within the previous 40 days had higher rates of severe events, ICU admission, ventilator use and death, but this was not the case for those who received only radiation. In this study, unlike Zhangs and Asciertos, people treated with immunotherapy did not fare so well. Four of the six patients who recently received checkpoint inhibitors had critical symptoms and two died.

Based on our analysis, COVID-19 patients with cancer tend to have more severe outcomes when compared to the non-cancer population, the researchers wrote. Although COVID-19 is reported to have a relatively low death rate of 2% to 3% in the general population, patients with cancer and COVID-19 not only have a nearly three-fold increase in the death rate than that of COVID-19 patients without cancer, but also tend to have much higher severity of their illness.

In a related study, Marina Chiara Garassino, MD, of Fondazione IRCCS National Tumor Institute in Milan, presented the first data from the international TERAVOLT registry, which is collecting data about COVID-19 among people with lung cancer and other thoracic malignancies. She noted that TERAVOLT was registering around 70 new cases per week from around the world per week.

This population may be especially vulnerable to COVID-19 due to older age, lung damage, smoking and underlying health conditions, Garassino said. Whats more, the symptoms of COVID-19 overlap with lung cancer, making diagnosis very challenging.

Garassino described results from the first 200 cancer patients with COVID-19 in more than 20 countries. Non-small-cell lung cancer was the most common type, and nearly three quarters had metastatic disease. About 20% received only targeted therapy, 33% received chemotherapy alone and 23% received immunotherapy alone.

A majority (76%) were hospitalized, but most were not offered intensive care for COVID-19; just 9% were admitted to an ICU and 3% were put on ventilators. More than a third (35%) died, mostly due to COVID-19 rather than cancer. Specific types of cancer treatment were not significantly associated with an increased risk of death.

But not all studies have seen worse COVID-19 outcomes among people with cancer. Fabrice Barlesi, MD, PhD, and colleagues looked at 137 COVID-19 patients with cancer at Gustave Roussy, a cancer center near Paris. They had a variety of cancer types, with blood cancers and breast cancer being most common. Nearly 60% had active advanced disease while 40% were in remission or being treated with potentially curative therapy.

Within this group, 25% had worsening COVID-19 after admission, 11% were admitted to the intensive care unit (ICU) and 15% died. Again, people with blood cancers were more likely to have worse outcomes. Treatment with chemotherapy within the past three monthsbut not targeted therapy or immunotherapydoubled the likelihood of worsening disease. But this only applied to people with active or metastatic cancer, not those who had localized disease or were in remission.

The 15% death rate among people with cancer at Gustave Roussy was lower than the 18% rate for all COVID-19 patients in Paris and in France, Barlesi said. His team concluded that both incidence and outcomes of COVID-19 among cancer patients seem to be comparable to the population as a whole. However, people with blood cancers, those treated with chemotherapy and frail patients are at greater risk.

Discussing how to manage cancer patients during the COVID-19 pandemic, Cai recommended self-protective isolation, strict infection control in hospitals and shifting some medical services online.

With regard to cancer treatment, she said, clinicians need to develop individualized plans based on a patients tumor type and stage of disease. She added that postponing surgery, if appropriate, should be considered in areas with current outbreaks. Radiation therapy, she said, could go ahead according to existing treatment plans with intensive protection and surveillance. Whether people with early-stage cancer need to postpone their treatment remains an unanswered question, she said.

Click hereto read the abstracts from the AACR COVID-19 and cancer session.Learn about What People With Cancer Need to Know About the New Coronavirus.

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