On July 26, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based in vivo gene editing and ex vivo allogeneic CAR T therapies, reported that it has received final meeting minutes from its recent Type B End of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for its lead investigational allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel) (Press release, Precision Biosciences, JUL 26, 2023, View Source [SID1234633442]).
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"The objective of our meeting with the FDA was to gain further clarity on the potential registration path for azer‑cel including study design, endpoints and the recommended phase 2 dose for the CAR T relapsed patient setting – a patient population with dire need for better therapeutic options," said Alan List, MD, Chief Medical Officer at Precision BioSciences. "We were able to accomplish the meeting objective and are appreciative of the FDA’s clear and thoughtful advice."
The meeting with the FDA provided clarity and direction on azer-cel development, including a potential pathway toward registration. Based on the advice received from the FDA and clinical data shared during the May 2023 CAR T update, Precision is currently advancing discussions with multiple potential strategic partners for its cell therapy assets, including hematologic and non-hematologic applications.
"The ongoing collaborative discussions are intended to help us meet two key objectives: securing the right partner to build on our clinical-stage CAR T assets and allowing us to focus on core capabilities of in vivo gene editing," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "We look forward to providing additional updates on our cell therapy strategic partnering initiatives as they develop."
In Vivo R&D Day to be Held on September 12, 2023
Precision will host its in vivo gene editing R&D Day on September 12, 2023. This presentation will be focused on providing an update on ARCUS in vivo gene editing candidates and the broad potential and versatility of the platform. Additionally, this timing will allow strategic partnering discussions around the ex vivo allogeneic cell therapies to mature and enable full investor attention on our in vivo gene editing pipeline.