FDA Clearance of Investigational New Drug Application for P-CD19CD20-ALLO1, an Allogeneic Dual CAR-T Cell Therapy for B-Cell Malignancies
“We are pleased to receive IND clearance for P-CD19CD20-ALLO1, our third fully allogeneic CAR-T cell product candidate and the second therapy in our partnership with Roche for hematological malignancies that will enter the clinic. We believe this represents the FDA’s first known IND clearance of an allogeneic dual CAR-T therapy targeting CD19 and CD20,” said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. “The dual-targeting approach leverages our proprietary non-viral piggyBac® DNA Delivery System, which enables expression of two fully functional CAR molecules into T cells from healthy donors for the treatment of B-cell malignancies that may have heterogeneous antigen expression. We believe that targeting both CD19 and CD20 has the potential to overcome the limitations of currently available CD19-directed CAR-T products where antigen escape has been observed as an important resistance mechanism. It has been estimated that up to 40% of cases where B-cell malignancies relapse or are refractory to CD19 targeting autologous CAR-T therapy may involve antigen escape. We look forward to dosing the first patients in this study.”
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