We have released exciting new coverage of the stem cell industry. Check it out and let me know what you think?
Abeona Therapeutics announced the U.S. FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ABO-102, the company’s AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease. It was the 16th RMAT designation awarded by the FDA and a landmark achievement in that it makes Abeona the first company to achieve two RMAT designations.
The cord blood and tissue banking market is consolidating, driven by the emergence of "holding companies” and frequent M&A activity. This is creating risks for cord blood market participants, as well as new opportunities. Cord blood banks are also becoming integrated therapeutic companies, with LifebankUSA now owned by Celularity (an augmented immunity and longevity company) and Americord announcing in a press release that it “intends to launch its first therapeutic product offering sometime in 2018.”
Cell & Gene Therapy Bioprocessing & Commercialization 2018Bringing together 300+ leaders and key influencers from pharma and biotech companies this September 4-7 in Boston, MA, Cell & Gene Therapy Bioprocessing & Commercialization will provide you with the latest advice for driving manufacturing and commercialization through direct access to innovative discovery, product development and regulatory know-how. Move between 4 tracks jam packed with topical talks and industry case studies, and meet with colleagues for an unrivalled on-site experience. Cell & Gene Therapy Bioprocessing & Commercialization is co-located with BioProcess International as part of Biotech Week Boston, allowing you access to additional sessions, as well as endless networking opportunities. Register using code "BIOINFORMANT" and receive 10% off your conference pass.
Vascugen Inc. announced that it has licensed a suite of intellectual property developed at the Indiana University (IU) School of Medicine related to blood vessel formation from adult stem cells. The regenerative medicine company is focused on finding therapies to repair tissues damaged by reduced blood flow due to disease or injury. The worldwide, exclusive licenses include patent rights to core intellectual property developed by Dr. Mervin C. Yoder, a Vascugen founder and IU Distinguished Professor Emeritus.
Kite Pharma Execs Form Allogene with Pfizer’s CAR-T Assets and $300M
Pfizer Inc. (NYSE:PFE) and Allogene Therapeutics, Inc. entered into an asset contribution agreement for Pfizer’s portfolio of assets related to allogeneic CAR T therapies. Allogene, a Two River portfolio company, was formed with Series A financing of $300 million. Pfizer will continue to participate financially in the development of the CAR T portfolio through a 25% ownership stake in Allogene. Separately, Pfizer continues to have an 8% ownership stake in Cellectis through an equity agreement entered into in 2014.
Hemostemix Announces First Patient Treated in Phase II Clinical Trial
Hemostemix (TSX VENTURE:HEM) announces that it has treated its first patient under its continuing Phase II Clinical Trial for critical limb ischemia (CLI). The first patient was treated at the Vancouver Coastal Health Research Institute, a world leader in translational health research for new therapies, led by the principal investigator, Dr. York N. Hsiang. VCHRI is the Company’s first Canadian trial site that is actively onboarding patients for the continuing trial. The Company has approximately 14 additional clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process.
CAR-T Funding Craze – Financing Rounds, Acquisitions, and IPOs
At first the trend was subtle, but the tide has swelled as CAR-T therapies like Kymriah and Yescarta have reached the marketplace and created a CAR-T funding craze. In major news released March 7, 2018, JW Therapeutics announced it had closed a $90 million Series A financing round. JW Therapeutics is a clinical stage biopharmaceutical company founded by Juno Therapeutics and WuXi AppTec Group in 2016 to focus on leading cell-based therapy technologies.
Exosome technologies have been developing rapidly over the past few years and substantial growth is expected for the market as they get integrated into the fields of liquid biopsy, precision medicine and regenerative medicine. Importantly, cancer exosomes influence the invasive potential of cells by regulating angiogenesis, metastasis, and immunity, making them an extremely useful source of biomarkers for use in cancer detection, diagnosis, and therapeutic selection. A great deal of venture capital has been flowing into the market, supporting financing rounds by Exosome Diagnostics, Codiak Biosciences, and ExCoBio, Inc.
Insights from the CEO of Celularity, Inc., Dr. Robert HaririCelularity is a biotech company that specializes in leveraging biologically active cell populations within the postpartum human placenta. Founded on the pioneering work of Dr. Robert Hariri, Celularity is uniquely positioned to harness the potential of the most biocreative event on earth: human birth. In addition to founding Celularity, Dr. Hariri is a pilot, surgeon, biomedical scientist, and serial entrepreneur. In this interview, we discuss Celularity’s formation, its leadership in living medicines, and the critical importance of industry collaboration. We also explore the company’s mission and long-term strategic goals.
Complete 2017-18 Global Cord Blood Banking Industry Report
With Bloomberg revealing that the largest cord blood bank in the U.S. (CBR) is up for sale, it is critical to understand cord blood industry forces. Price competition is growing and organic growth strategies are being paired with inorganic (M&A) growth strategies. New types of perinatal stem cell storage services are being introduced and placental stem cell storage is coming of age. Dental stem cell storage is also accelerating as a complimentary or stand-alone service. Globally, industry consolidation is a major trend, as market leaders struggle to stay in business. In Asia, Global Cord Blood Corporation is seeking to expand internationally and Sanpower Group now controls 1.1 million cord blood units across China and Southeast Asia.
The report analyzes time frames for cell therapy product development, distribution channels, key trends and technologies impacting cell therapy manufacturing, cost control measures, and challenges and considerations affecting with cell therapy manufacturing. It provides an overview of the regulatory environment affecting cell therapy manufacturing in key countries worldwide, evaluating the importance of the recent U.S. FDA guidelines for HCT/Ps and the 21st Century Cures Act, as well as accelerated pathways for cell therapy approvals in Japan, South Korea, and the EU. This global strategic report offers critical insights into strategies for optimizing modern cell therapy manufacturing.
Be Great,
Cade President/CEO of BioInformant.com "1st and Only Market Research Firm to Specialize in the Stem Cell Industry"
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