FDA Approves Improved Azer-cel Manufacturing Process for Blood Cancer Therapy

Imugene Limited (ASX: IMU) has received favorable feedback from the FDA regarding an improved manufacturing process for azer-cel, an allogeneic CD19 CAR T-cell therapy designed for autologous CART-relapsed patients with blood cancers. This development signifies a significant step towards greater robustness, consistency, and scalability in the production of azer-cel. The FDA's support for this manufacturing process is pivotal as it can be utilized in the forthcoming clinical trial and for the eventual commercial production of the therapy. Azer-cel is currently undergoing a Phase 1b clinical trial in patients with non-Hodgkin's lymphoma (NHL) and acute lymphocytic leukemia (ALL), demonstrating clinically meaningful results with an acceptable safety profile.

This positive FDA feedback sets the stage for a potential pivotal study in 2024, positioning azer-cel as a promising candidate to become the first approved allogeneic CAR T-cell therapy for cancer treatment. Imugene plans to use its advanced GMP manufacturing facility in North Carolina to produce azer-cel, with future applications extending to the treatment of solid tumors in combination with the onCARlytics platform.

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