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news.Poseida Therapeutics has received the US Food and Drug Administration’s (FDA) orphan drug designation for its new chimeric antigen receptor (CAR)-T therapy candidate, P-BCMA-ALLO1, to treat multiple myeloma.
The CAR-T product candidate is being developed for relapsed/refractory multiple myeloma. Credit: www.scientificanimations.com/commons.wikimedia.org.
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The allogeneic CAR-T product candidate is being developed in partnership with Roche for relapsed/refractory multiple myeloma (RRMM).
P-BCMA-ALLO1 targets the B-cell maturation antigen (BCMA) and is enriched with T stem cell memory (TSCM) cells.
Currently, the therapy is being evaluated in a Phase I clinical trial.
The early safety and preliminary efficacy data shared at the 65th ASH Annual Meeting and Exposition last December indicated that P-BCMA-ALLO1 was well-tolerated as an off-the-shelf therapy. It was delivered to 100% of patients in the intent-to-treat population without the need for bridging chemotherapy or other anti-myeloma therapies.
Preliminary data also demonstrated that the allogeneic TSCM-rich CAR-T cells trafficked to the bone marrow, differentiated into cell-killing effector T cells, and persisted for at least six weeks post-treatment. This suggests the potential for long-term cell persistence at tumour-relevant sites.
Looking ahead, Poseida, in coordination with Roche, plans to provide further clinical updates on the P-BCMA-ALLO1 programme at a scientific meeting in the second half of this year.
Poseida Therapeutics president and CEO Kristin Yarema said: “The orphan drug designation for P-BCMA-ALLO1 underscores the high unmet medical need for a rapid and accessible off-the-shelf allogeneic CAR-T therapy for patients with multiple myeloma.
“This designation further validates our belief 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.”
