The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T-cell lymphomas, with these CAR T cells. I think this year, we are feeling reassured in this regard,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told the Alliance for Regenerative Medicine briefing at the J. P. Morgan Healthcare Conference on Jan. 13.
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.
Galapagos NV is abandoning its small molecule roots to focus on cell therapy and at the same time splitting in two, with the spinout company, dedicated to acquiring a portfolio of assets, taking the lion’s share of the capital.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Kyverna Therapeutics Inc. has presented details on the development and preclinical characterization of KYV-102, an autologous fully human anti-CD19 CAR T-cell therapy developed for diseases driven by B cells, such as systemic lupus erythematosus (SLE), among others.
To address limitations with CAR T therapies targeting CD19, Allogene Therapeutics Inc. has developed ALLO-329, a CD19/CD70-targeting CAR therapy that is able to deplete activated alloreactive lymphocytes, while endowing dual targeting of CD19+ B cells and CD70+ T cells.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
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