FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.
Poseida Therapeutics, a US-based clinical-stage biopharmaceutical company specializing in cell and gene therapeutics using its proprietary genetic engineering platform technologies, received clearance in December 2021 by FDA for its investigational new drug (IND) application for P-MUC1C-ALLO1, an allogeneic chimeric antigen T cell (CAR-T) product candidate which the company is developing to treat multiple solid tumors.
The IND clearance for P-MUC1C-ALLO1 follows an IND clearance the company received for its P-BCMA-ALLO1, another allogeneic CAR-T therapy candidate in development for treating relapsed/refractory multiple myeloma. P-MUC1C-ALLO1 is the first product candidate to be produced out of the company’s new good manufacturing practice facility—an internal pilot manufacturing plant—at its San Diego, Calif., headquarters.
P-MUC1C-ALLO1 will be evaluated in a Phase I study in adults with locally advanced or metastatic epithelial-derived solid tumors refractory to standard of care therapy, or those deemed ineligible or who have been refused another existing treatment option. The study will evaluate the safety, tolerability, and preliminary efficacy of the product candidate.
“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, CEO of Poseida Therapeutics, in a Dec. 20, 2021 company press release. “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.”