SAN DIEGO - Poseida Therapeutics, Inc. (NASDAQ: PSTX), a clinical-stage biopharmaceutical company, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for P-BCMA-ALLO1, its investigational therapy for multiple myeloma, a type of blood cancer.
The designation is intended to advance treatments for rare diseases affecting fewer than 200,000 people in the U.S. and comes with benefits such as tax credits and potential seven-year market exclusivity upon approval.
P-BCMA-ALLO1 is an allogeneic chimeric antigen receptor (CAR)-T therapy targeting B-cell maturation antigen (BCMA), developed for patients with relapsed or refractory multiple myeloma. It is part of Poseida's collaboration with Roche and is currently being evaluated in a Phase 1 clinical trial.
Early data presented in December 2023 at the American Society of Hematology (ASH) Annual Meeting showed the therapy to be well-tolerated with positive safety and preliminary efficacy outcomes.
The company announced the therapy's favorable safety profile, its ability to reach and persist in bone marrow, and the lack of need for bridging chemotherapy in the intent-to-treat population. Further data on the treatment's efficacy in patients who have previously undergone BCMA-targeted therapy will be presented at the American Association for Cancer Research (AACR) Annual Meeting on April 8, 2024.
Poseida Therapeutics specializes in cell and gene therapies for cancer and rare diseases, employing proprietary genetic editing platforms and in-house manufacturing capabilities. The Orphan Drug Designation underscores the potential of P-BCMA-ALLO1 to meet the unmet medical needs of multiple myeloma patients.
Additional updates on the therapy's clinical progress are expected in the second half of 2024. This news is based on a press release statement from Poseida Therapeutics, Inc.
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