Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors
SAN DIEGO, Dec. 20, 2021 /PRNewswire/ — Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-MUC1C-ALLO1, the Company’s allogeneic CAR-T product candidate targeting multiple solid tumor indications.
“We are excited to begin the P-MUC1C-ALLO1 trial, an evaluation of a fully allogeneic CAR-T product candidate with the potential to treat a wide range of solid tumors, including breast, ovarian and other cancers,” said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. “The genetic edits in P-MUC1C-ALLO1 have been shown to reduce or fully eliminate alloreactivity, and our proprietary manufacturing process, which includes our booster molecule, has the potential to treat many patients from a single manufacturing run. We look forward to beginning this trial and to presenting initial clinical data in 2022.”