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Poseida Therapeutics (Poseida) presented positive early results from its Phase I trial of allogenic CAR-T P-BCMA-ALLO1 in relapsed-refractory multiple myeloma at the 65th American Society of Hematology Annual Meeting.
Clinical-stage biopharmaceutical company, Poseida, presented encouraging early results from its Phase I trial of P-BCMA-ALLO1 at the 65th American Society of Hematology (ASH) Annual Meeting. The allogeneic, T stem cell memory (TSCM)-rich CAR-T therapy showed promise in treating relapsed/refractory multiple myeloma (RRMM), providing a potential off-the-shelf solution.
“This is also the first known publicly presented data set that provides clear clinical evidence supporting the hypothesis that TSCM cells are the ideal cell type for allogeneic CAR-T, extending our previous findings with autologous TSCM cells to the allogeneic setting,” declared Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. “We hope that TSCM-rich allogeneic CAR-T therapies may potentially offer the optimal combination of clinical results, on-demand availability and high-volume production, while supporting broader access to CAR-T therapies. We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results. They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio.”
The key findings include:
- The study demonstrated an impressive 82% overall response rate (ORR) in heavily pretreated patients with RRMM, with deep clinical responses observed. Patients not previously treated with a BCMA-targeted bispecific T cell-engaging antibody achieved a 100% ORR.
- P-BCMA-ALLO1 exhibited a favorable safety profile, with all intent-to-treat patients receiving therapy, no graft-vs-host disease (GvHD), and low incidences of cytokine release syndrome (CRS) and neurotoxicity, all Grade 2 or less.
- Allogeneic TSCM-rich CAR-T cells showed promising persistence and trafficking to the bone marrow, differentiating into cell-killing effector T cells and persisting for at least 6 weeks.
- The study highlighted the importance of the conditioning dose of cyclophosphamide in the expansion and persistence of CAR-T cells. Patients receiving higher cyclophosphamide doses demonstrated superior clinical responses.
- Poseida Therapeutics also showcased advancements in its cell and gene therapy programs, including a potent in vivo bioassay for assessing BCMA CAR-T potency and data suggesting greater potency in the P-BCMA-ALLO1 drug product compared to earlier autologous programs.
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The company plans to continue enrollment and explore additional dose regimens and lymphodepleting conditioning regimens. Further clinical data updates for P-BCMA-ALLO1 are expected in 2024, subject to coordination with Roche, its partner in this initiative.
Source: Poseida Therapeutics Press Release
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