Encouraging initial findings indicate that individuals with relapsed or refractory multiple myeloma, who experienced progression post BCMA-directed treatments, have shown clinical improvements with P-BCMA-ALLO1, demonstrating a good safety profile.
Poseida Therapeutics, a biopharmaceutical firm focused on cell and gene therapies, has unveiled new insights from a Phase 1 clinical trial subset, highlighting the potential of their leading program, P-BCMA-ALLO1. The study revealed a 60% clinical response rate among the evaluated patients, with the treatment proving to be well-tolerated. P-BCMA-ALLO1, an innovative allogeneic CAR-T therapy, targets the B-cell maturation antigen (BCMA) and is derived from healthy donor T-cells, offering an off-the-shelf solution. The latest data from the Phase 1 trial, along with an analysis of lymphodepletion regimens for multiple myeloma and solid tumor patients treated with P-BCMA-ALLO1 and P-MUC1C-ALLO1, respectively, were showcased at the AACR Annual Meeting 2024.
Dr. Bhagirathbhai Dholaria, a hematology/oncology expert, emphasized the urgency for new treatment options, noting the Phase 1 results as a promising development in treating heavily pre-treated patients with myeloma that has advanced after several BCMA-targeted treatments.
Dr. Syed Rizvi, Poseida's Chief Medical Officer, mentioned that the new data reinforce the potential of their allogeneic CAR-T therapy for a wider patient population, including those with advanced refractory disease, and discussed the ongoing efforts to refine lymphodepletion strategies for solid tumors. The Phase 1 study, an open-label, multicenter dose-escalation trial, is designed to evaluate the safety and optimal dosing of P-BCMA-ALLO1, as well as its effectiveness against myeloma. Key outcomes from the analysis indicated a 60% response rate, with all responding patients achieving a very good partial response (VGPR), and no occurrence of severe toxicities or significant side effects.
Furthermore, the study compared lymphodepletion regimens using different doses of cyclophosphamide to optimize CAR-T cell therapy for solid tumor patients, suggesting that higher doses may be necessary for these patients. The detailed findings were presented in poster sessions by Dr. Rajesh Belani and Dr. Sabrina Haag, both of Poseida Therapeutics. P-BCMA-ALLO1, licensed to Roche, is currently in Phase 1 development for treating relapsed/refractory multiple myeloma patients and has received Orphan Drug Designation from the FDA.
Poseida's P-MUC1C-ALLO1 is also in Phase 1 development, targeting a variety of solid tumors and designed to be fully allogeneic with genetic modifications to minimize alloreactivity. Poseida Therapeutics is dedicated to developing transformative cell and gene therapies, with a robust pipeline that addresses both solid and liquid tumors, as well as rare diseases. The company's technology platforms include advanced genetic editing systems and manufacturing processes. They are in collaboration with Roche to enhance the impact of cell therapies for hematological malignancies.
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