Precision BioSciences announces FDA provided Type C feedback on Azer-cel

Precision BioSciences announced that the FDA provided Type C feedback on the company’s CMC processes and analytical methods for azercabtagene zapreleucel. Azer-cel is Precision BioSciences lead allogeneic CAR T candidate being evaluated for relapsed or refractory non-Hodgkin lymphoma, or NHL, in subjects who have relapsed following autologous CAR T treatment. "We are pleased with the FDA feedback on key components of our planned CMC package to support azer-cel ongoing development. The responses to questions regarding our analytical methods, proposed potency assays, and manufacturing processes are aligned with our expectations and help guide our plans," said Karl Whitney, Vice President and Head of Regulatory Affairs at Precision BioSciences. "We appreciate the FDA’s input and look forward to continuing regulatory engagement at critical points along our development horizon." "We look forward to continuing enrollment in the ongoing Phase 1/2a trial and working closely with the FDA as we pursue development of azer-cel. Azer-cel has the potential to become the first allogeneic CAR T therapy to reach the market," said Alan List, chief medical officer at Precision BioSciences. "There are currently no FDA-approved allogeneic CAR T products to address the high unmet need of the CAR T relapsed or refractory patient population. While autologous CAR T therapy is a promising treatment option for hematological malignancies, up to 60% of high-grade NHL patients relapse after treatment and up to 20% of intended auto-CAR T patients never receive treatment due to inability to manufacture the CAR T product. An effective off-the-shelf allogeneic CAR T treatment has the potential to offer clinical benefit to this growing population of lymphoma patients."