FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Poseida Therapeutics P-BCMA-ALLO1, an investigational stem cell memory T cell (TSCM)-based allogeneic CAR-T cell therapy for treating relapsed/refractory multiple myeloma (R/RMM).
P-BCMA-ALLO1 is currently in phase 1/1b clinical development, offering hope to patients with R/RMM.
Kristin Yarema, CEO of Poseida Therapeutics, stated that RMAT designation for P-BCMA-ALLO1 is based on impressive early clinical data from our ongoing phase 1 study, validating its potential for patients with R/RMM.
She emphasized the significance of RMAT and Orphan Drug designations, highlighting the encouraging clinical responses in R/RMM patients and initiating the phase 1b trial as critical advancements in this next-generation CAR-T therapy.
RMAT designation provided Poseida with various benefits, including early interactions with the FDA, accelerated review timelines, and the potential for accelerated approval based on surrogate or intermediate endpoints.
Poseida will present new clinical data from the P-BCMA-ALLO1 phase 1 study at the 21st International Myeloma Society Annual Meeting in Rio de Janeiro.
