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FDA Clears Poseida Therapeutics' Investigational New Drug Application for P-CD19CD20-ALLO1, an Allogeneic Dual CAR-T Cell Therapy for B-Cell Malignancies

Thursday, July 06, 2023

Poseida Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-CD19CD20-ALLO1, a dual CAR-T cell product candidate. P-CD19CD20-ALLO1 is being developed in partnership with Roche and targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies. It is the company's third fully allogeneic CAR-T cell product candidate and the second therapy in their partnership with Roche for hematological malignancies.

The clearance of the IND allows Poseida Therapeutics to proceed with a Phase 1 multi-center, open-label, dose-escalation study. This study will enroll up to 70 adult patients with relapsed or refractory B-cell malignancies to evaluate the safety, tolerability, and preliminary efficacy of P-CD19CD20-ALLO1. The patients will receive a chemotherapy-based lymphodepletion regimen followed by the administration of P-CD19CD20-ALLO1 allogeneic CAR-T cells.

P-CD19CD20-ALLO1 is an allogeneic CAR-T cell therapy product candidate that expresses two fully functional CAR molecules to target cells expressing either CD19 or CD20. The dual targeting approach aims to overcome the limitations of CD19-only targeted CAR-T therapies by simultaneously targeting both CD19 and CD20 antigens. Additionally, P-CD19CD20-ALLO1 utilizes a novel CD19 binder that has shown greater potency in preclinical models compared to the standard FMC63 Single-chain variable fragment (scFv) binder.

One advantage of P-CD19CD20-ALLO1 is that it is an off-the-shelf CAR-T therapy, meaning patients do not have to undergo apheresis and wait for their cells to be manufactured. This can potentially overcome the time-consuming manufacturing process associated with autologous CAR-T therapies. The therapy will be studied in multiple B-cell malignancies.

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