Posted by Michael Wonder on 06 Nov 2018
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-101
5 November 2018 - Poseida Therapeutics today announced the U.S. FDA has granted a regenerative medicine advanced therapy designation to P-BCMA-101, Poseida’s lead CAR-T therapeutic candidate currently in a Phase 1 clinical trial for the treatment of patients with relapsed/refractory multiple myeloma.
P-BCMA-101 is an autologous CAR-T therapeutic candidate being developed to treat patients with relapsed/refractory multiple myeloma. P-BCMA-101 targets cells that express B cell maturation antigen, or BCMA, which is expressed on essentially all multiple myeloma cells. P-BCMA-101 is engineered with Poseida’s non-viral piggyBac DNA Modification System, resulting in a high percentage of T stem cell memory cells.
Preliminary results from the company’s ongoing Phase 1 clinical trial suggest that P-BCMA-101 may have improved response rates with a favourable safety profile compared to published results from clinical trials of other CAR-T therapies at similar doses. Low to no levels of cytokine release syndrome or neurotoxicity have been seen. The Phase 1 study is funded in part by the California Institute for Regenerative Medicine.
