CELL AND GENE THERAPY
Valneva SE, IDT Biologika | November 30, 2021
Valneva SE, a specialty vaccine company, and IDT Biologika announced their collaboration for the production of Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last week’s announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years.
Under the collaboration, IDT Biologika will produce VLA2001’s drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland.
“IDT is a well-established partner within Valneva’s manufacturing network. As such we are extremely pleased to extend this partnership to supply VLA2001. This collaboration will help ensure our inactivated vaccine is available for rapid deployment as we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.”
Thomas Lingelbach, Chief Executive Officer of Valneva
Dr. Jürgen Betzing, Chief Executive Officer of IDT Biologika, added, “This is great news for our company. This assignment shows the importance of the role played by IDT in the fight against COVID-19. It is a great achievement and demonstrates the trust that Valneva has placed in us and our employees. The expansion of our production capacity combined with our expertise were key factors in the choice of IDT.”
Valneva has continued to review its manufacturing strategy following discussions with the UK Government in the summer and again after the termination of the UK contract in September 2021. Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand. The Company’s sites in Livingston, Scotland and Solna, Sweden will continue to form part of the Company’s core manufacturing strategy.
Valneva reported positive Phase 3 results for VLA2001 in October 20211. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the European Medicines Agency which is expected to start a rolling review of VLA2001 shortly.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
About IDT Biologika
IDT Biologika is an innovative biotech company with a successful history dating back 100 years. On the basis of modern technologies and high levels of expertise, we support customers in the development and manufacture of innovative virus vaccines, gene and immune therapy products as well as biologics employed worldwide as protection against diseases. German sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the US, the IDT Corporation has a manufacturing site for clinical test samples in Rockville, Maryland.
CELL AND GENE THERAPY
Cellares Corporation | July 16, 2021
Cellares Corporation, a life sciences technology company that has pioneered a revolutionary automated approach to cell therapy manufacturing announced today that Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company that uses proprietary genetic engineering platform technologies to create cell and gene therapeutics with the potential to cure, has joined its Early Access Partnership Program (EAPP). Poseida joins PACT Pharma and academic partner Fred Hutchinson Cancer Research Center as the third entity to join Cellares' EAPP.
Cellares launched the EAPP in 2020 to provide participants awareness and early access to Cellares' Cell Shuttle, a next-generation cell therapy manufacturing platform that enables closed, automated, and scalable cell therapy production. Poseida's involvement in the initiative adds to the Cell Shuttle's development, range of usage, and applicability by providing insight and experience in manufacturing processes for various autologous and allogeneic cell therapies.
Poseida is presently testing two autologous CAR-T product candidates in the clinic: P-BCMA-101 for relapsed/refractory multiple myeloma and P-PSMA-101 for metastatic castrate-resistant prostate cancer. The firm, which completed an initial public offering in July 2020, is also developing off-the-shelf versions of these treatments and TCR-T, anti-c-kit CAR-T, induced pluripotent stem cells (iPSCs), genetically modified hematopoietic stem cells (HSCs), and NK cells. In addition, Carl June, M.D., an immunotherapy pioneer and renowned oncologist who advised Cellares on creating the Cell Shuttle has just joined Poseida's Immuno-Oncology Scientific Advisory Board.
Poseida will assess the Cell Shuttle prototypes and give statistics and written comments related to their function and performance as part of Cellares' EAPP. In addition, user studies will be conducted to assess the Cell Shuttle's hardware and software, product requirements, release criteria, and process processes to ensure product-market fit.
About The Cell Shuttle
The Cell Shuttle is a flexible and scalable automated and closed end-to-end production solution that allows clients to execute the precise procedures required for their cell therapy. Compared to presently existing cell therapy manufacturing methods, this next-generation platform allows for a threefold decrease in process failure rates and the ability to produce 10+ patient doses in parallel, improving manufacturing scalability by order of magnitude. For most processes, this will reduce per-patient manufacturing costs by up to 70%.
About Cellares Corporation
Cellares is rethinking cell therapy manufacturing and accelerating access to life-saving cell therapies. The business is working on a one-of-a-kind approach to solving the difficulties of generating cell therapies that are cheaper and broadly accessible to people in need. Cellares' proprietary platform, the Cell Shuttle, eliminates the need for biopharma companies, academic research centers, and CDMOs to choose between a manufacturing platform that is semi-automated but lacks workflow flexibility or one that provides customization but lacks the end-to-end automation required to manufacture at scale. The business is based in South San Francisco, California.
Spotlight Therapeutics | March 22, 2022
Spotlight Therapeutics, Inc. (“Spotlight”), a biotechnology company applying new insights to develop cell-targeted in vivo CRISPR gene editing biologics, today announced a $36.5M Series B financing to fuel a drive toward the clinic.
The financing round was co-led by new investors GordonMD Global Investments and EPIQ Capital Group, with participation from Magnetic Ventures, as well as existing investors GV (formerly Google Ventures) and Emerson Collective and other investors. Craig Gordon, M.D., Founder, CEO and CIO of GordonMD Global Investments, joins the Company’s Board of Directors.
Spotlight's proprietary technology platform, TAGE (Targeted Active Gene Editors), is a new class of biologics; highly engineered, modular programmable CRISPR effectors designed to target and edit selected cell types in vivo. This approach circumvents the complexity of packaged viral, viral-like, and nanoparticle delivery systems, opens the door to expanded applications, and holds the promise of increasing patient access.
We are excited to help Spotlight advance its pioneering work, which shows promise for cell-targeted delivery of CRISPR effectors in vivo. Spotlight’s TAGE platform could enable significant expansion of CRISPR medicines to a wide range of diseases."
This Series B funding is a crucial milestone as we advance our lead first-in-class immuno-oncology (IO) program and progress our pipeline of programs in IO, ophthalmic diseases and hemoglobinopathies,It will enable us to execute our development plan, leveraging Spotlight’s unique cell-targeted in vivo delivery approach, as we aspire to unlock the full potential of gene editing and enable effective one-and-done medicines for patients.”
Mary Haak-Frendscho, Ph.D., President and CEO of Spotlight Therapeutics.
About Spotlight Therapeutics
Established in mid-2018, Spotlight Therapeutics is a privately held biotechnology company advancing a pipeline of cell-targeted in vivo CRISPR gene editing therapies. Spotlight's proprietary technology platform TAGE (Targeted Active Gene Editors) is a new class of biologics, CRISPR effectors engineered for direct delivery in vivo, to achieve cell-selective therapeutic genome editing. Spotlight's pipeline is advancing its modular programmable CRISPR effectors towards clinical studies in immuno-oncology, ophthalmic diseases and hemoglobinopathies. The company is headquartered in Hayward, California.