Allogene Therapeutics(US:ALLO) Prnewswireยท2024-09-16 12:00Core Insights - The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1, an investigational allogeneic CAR-T cell therapy for relapsed/refractory multiple myeloma, based on positive clinical data from an ongoing Phase 1 study [1][2][3] - RMAT designation allows for increased dialogue with the FDA and includes benefits similar to Fast Track and Breakthrough Therapy designations, facilitating the development process [2][4] Company Overview - Poseida Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on advancing allogeneic cell therapies and genetic medicines for cancer and rare diseases [7] - The company utilizes proprietary genetic editing platforms and has formed strategic collaborations with Roche and Astellas to enhance its therapeutic offerings [7] Clinical Development - P-BCMA-ALLO1 is designed to target B-cell maturation antigen (BCMA) and has shown promising efficacy and safety in early clinical trials, particularly in patients who have received prior BCMA-targeted therapies [3][6] - New clinical data from the ongoing Phase 1 study will be presented at the 21st International Myeloma Society Annual Meeting from September 25-28, 2024 [3][6] Regulatory Insights - The RMAT designation is part of the 21st Century Cures Act, aimed at expediting the development and review of regenerative medicine therapies for serious conditions [4] - Therapies with RMAT designation may be eligible for accelerated approval based on surrogate or intermediate endpoints that predict long-term clinical benefits [5]