March 7, 2022, Palo Alto, California — I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up, announced that the company had tripled its capacity to manufacture GMP grade iPS cells and iPSC-derived differentiated cells by expanding its facility. The facility’s expansion, designed to conform to GMP standard, is now almost complete and is expected to start manufacturing cGMP grade cells in April this year after going through a regulatory review and FDA registration update. With this CDMO facility expansion, I Peace will be able to meet the growing needs for GMP iPS cells from pharmaceutical companies and cell therapy developers, and better serve individuals with increased personal iPS cell banking service capacity. [Read more…]
Placental-Derived Allogeneic Stem Cells Meet the Needs of the Market and the Patient
As an increasing number of stem cell therapies advance through clinical trials, the healthcare industry’s focus comes to looking at which cells, allogeneic or autologous, are more likely to be commercially feasible. Proving safety and efficacy for a specific indication is a large enough challenge for any treatment, but for stem cell therapies in particular, commercial viability may be just as big a hurdle.
Israel-based Pluristem Therapeutics (NASDAQ:PSTI), may be the only stem cell company that can mass produce immune-privileged allogeneic cells at a scale and price that not only makes them commercially viable, but moreover makes stem cell therapy a preferred method of treatment for patients and payors alike. A proprietary 3D stem cell expansion technology which uses placental-derived cells is the key. [Read more…]
Ciloa secures €5 million for the development of its new generation of biomedicines and vaccines using exosomes
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The company finalized a €3.5 million fundraising and obtained €1.5 million in public funding as part of the “Emerging Infectious Diseases and CBRN Threats” call for proposals of the France 2030 investment plan, operated on behalf of the French government by Bpifrance. This aid was more specifically granted for the development of a natural vaccine against the Covid-19 delta variant.
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With its own production unit to meet GMP (Good Manufacturing Practices) standards, Ciloa is now positioned as a major player in the development of therapeutic and preventive products using its tailor-made exosome modification technology.
Exogenus Therapeutics and Boehringer Ingelheim Collaboratively Explore Extracellular Vesicles for Regenerative Medicine Applications
Cantanhede, Portugal, March 2, 2022 – Exogenus Therapeutics is proud to announce a new research collaboration with Boehringer Ingelheim to explore the use of extracellular vesicles as therapeutic tools for regenerative medicine. This joint effort led by Boehringer Ingelheim’s Research Beyond Borders (RBB) Unit focuses on pre-clinical testing of Exogenus Therapeutics’ lead candidate Exo-101, in various regenerative medicine indications. [Read more…]
Legend Biotech’s CARVYKTI™ Becomes Latest CAR-T Therapy Approved by U.S. FDA
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CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma
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CARVYKTI™ marks the first product approved by a health authority for Legend Biotech
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Approval is primarily based on the pivotal phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate (ORR) of 98 percent in patients with refractory or relapsed multiple myeloma after four or more prior lines of therapy including proteasome inhibitor, immunomodulatory agent and anti-CD38 monoclonal antibody1
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