Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for P-BCMA-ALLO1 to Treat R/R Multiple Myeloma
“The RMAT designation for P-BCMA-ALLO1, our lead program, is based on impressive early clinical data from our ongoing Phase 1 study and further validates its potential to address the unmet needs of patients with relapsed/refractory multiple myeloma,” said Kristin Yarema, Ph.D., president and chief executive officer of Poseida Therapeutics. “Importantly, our data has shown clinical responses in very sick, refractory patients, including those that have received prior BCMA-targeted therapies. With both RMAT and Orphan Drug designations for P-BCMA-ALLO1, we look forward to working closely with the FDA as we continue to advance this next-generation, off-the shelf allogeneic CAR-T therapy, including the recently initiated Phase 1b portion of the trial.”
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