Poseida Therapeutics, a clinical-stage company specializing in cell and gene therapy, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-CD19CD20-ALLO1. This therapy is an allogeneic dual CAR-T cell product candidate developed in partnership with Roche. It targets both CD19 and CD20 antigens and is designed to treat relapsed or refractory B-cell malignancies.
P-CD19CD20-ALLO1 utilizes Poseida's proprietary non-viral piggyBac® DNA Delivery System, which enables the expression of two fully functional CAR molecules in T cells from healthy donors. This approach aims to overcome the limitations of CD19-only CAR-T therapies by simultaneously targeting both CD19 and CD20 antigens.
One of the advantages of P-CD19CD20-ALLO1 is that it is an off-the-shelf CAR-T therapy, eliminating the need for apheresis and lengthy manufacturing processes associated with autologous CAR-T therapies. This can potentially provide a more efficient and accessible treatment option for patients.
The clearance of the IND application allows Poseida Therapeutics to proceed with clinical trials to assess the safety and efficacy of P-CD19CD20-ALLO1 in various B-cell malignancies. This development marks an important milestone in the advancement of innovative therapies for cancer treatment.