Research Solutions | October 12, 2020
Research Solutions/Reprints Desk (NASDAQ: RSSS), a pioneer in providing cloud-based workflow solutions for R&D driven organizations, today announced that it has partnered with BIO Business Solutions to help life sciences companies save time and money on scholarly literature access via its award-winning Article Galaxy research platform. Operated by the Biotechnology Innovation Organization (BIO), BIO Business Solutions is the industry's largest cost savings purchasing program. More than 4,500 member companies worldwide—including biotechnology and biopharmaceutical firms, medical device firms, academic institutions, state biotechnology centers, and related organizations—together save more than $511 million annually through the BIO Business Solutions® program.
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INOVIO | September 28, 2020
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed. This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification. In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial.
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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.
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