Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors
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.”
P-MUC1C-ALLO1 is the Company’s second fully allogeneic CAR-T product candidate to receive IND clearance in 2021 following P-BCMA-ALLO1 for the treatment of relapsed/refractory multiple myeloma. P-MUC1C-ALLO1 is the first product candidate to be produced out of the Company’s new GMP facility, an internal pilot manufacturing plant located at its San Diego headquarters.
P-MUC1C-ALLO1 will be evaluated in a Phase 1 multi-center, open-label, dose escalation study in adults with locally advanced or metastatic epithelial-derived solid tumors refractory to standard of care therapy, or those deemed ineligible or refused another existing treatment option. The study will evaluate the safety, tolerability, and preliminary efficacy of P-MUC1C-ALLO1 and will follow a 3+3 design of dose-escalating cohorts. After a subject enrolls, P-MUC1C-ALLO1 allogeneic CAR-T cells will be administered, following a standard chemotherapy-based conditioning regimen. The study protocol allows for exploration of additional dosing regimens, including re-dosing once initial safety has been established.