Poseida Therapeutics’ P-BCMA-ALLO1 Receives US FDA RMAT Designation
Poseida Therapeutics’ P-BCMA-ALLO1 receives US FDA RMAT designation to treat relapsed/refractory multiple myeloma
Overview
Poseida Therapeutics, Inc., a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, announced that the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1, an investigational stem cell memory T cell (TSCM)-based allogeneic CAR-T cell therapy in phase 1/1b clinical development for the treatment of patients with relapsed/refractory multiple myeloma.
About RMAT Designation
- RMAT designation includes all the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA.
- Poseida's RMAT application was evaluated based on encouraging early data from its ongoing phase 1 study of P-BCMA-ALLO1, which demonstrated P-BCMA-ALLO1's potential to offer promising efficacy, safety profile and rapid 'off-the-shelf' patient access.
From the CEO: Poseida Therapeutics
- 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,"" 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.
New Clinical Data Presentation at Myeloma Society Annual Meeting
- The company will report new clinical data from the P-BCMA-ALLO1 phase 1 study in an oral session at the 21st International Myeloma Society Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024.
- Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche, which has a strategic collaboration with Poseida covering multiple investigational allogeneic CAR-T therapies targeting blood cancers, including P-BCMA-ALLO1.
Details on RMAT Designation
- The RMAT designation is a programme under the 21st Century Cures Act that is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions.
- A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such disease or condition.
- RMAT designation includes all Breakthrough Therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints.
- RMATs may be eligible for accelerated approval based on previously agreed-upon surrogate or intermediate endpoints that are reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.
About the P-BCMA-ALLO1
- P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma.
- This allogeneic program includes a VH-based binder that targets BCMA and clinical data presented at ASH in December 2023 support the company's belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma.
- The FDA has granted P-BCMA-ALLO1 Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and anti-CD38 antibody in addition to Orphan Drug designation for multiple myeloma.
About the Company
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure certain cancers and rare diseases.
