Poseida Therapeutics has received the Regenerative Medicine Advanced Therapy (RMAT) designation from FDA for its investigational stem cell memory (TSCM) T cell-based allogeneic CAR-T (P-BCMA-ALLO1)
Poseida Therapeutics has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational stem cell memory (TSCM) T cell-based allogeneic CAR [chimeric antigen receptor]-T cell therapy, P-BCMA-ALLO1.
This therapy is currently in Phase I/Ib clinical development for patients with relapsed/refractory multiple myeloma.
The RMAT designation, which encompasses the benefits of both the fast track and breakthrough therapy programmes, is based on encouraging early data from the Phase I study of P-BCMA-ALLO1, which has shown potential in efficacy and safety profile, as well as rapid “off-the-shelf” accessibility for patients.
Poseida Therapeutics CEO and president Kristin Yarema stated: “The RMAT designation for P-BCMA-ALLO1, our lead programme, 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.
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.”