Precision BioSciences Receives Favorable Type C Feedback from the FDA on the Company’s Chemistry, Manufacturing, and Controls (CMC) Strategies for Late-Stage Development of Azercabtagene Zapreleucel
- FDA feedback signals the Company’s CMC plans shared are in alignment with Agency requirements and expectations
- CMC regulatory feedback is a critical step in the pathway for development of azer-cel
DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced that the U.S. Food and Drug Administration (FDA) provided supportive Type C feedback on the Company’s CMC processes and analytical methods for azercabtagene zapreleucel (azer-cel; PBCAR0191). Azer-cel is Precision BioSciences lead allogeneic CAR T candidate being evaluated for relapsed or refractory (R/R) non-Hodgkin lymphoma (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, M.D., 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.”
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the company’s pipeline consists of multiple ex vivo “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene editing candidates designed to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.
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Source: Precision BioSciences, Inc.