Imugene Ltd (ASX:IMU, OTC:IUGNF) has begun incorporating positive FDA feedback into its plans to manufacture azercabtagene zapreleucel (azer-cel), anallogeneic (off the shelf) CD19CAR T-cell therapy, for autologous (auto) CART-relapsed patients with blood cancers.
The company says the FDA’s suggestions will lead to an improved manufacturing process that allows for greater robustness, consistency and scalability.
“Azer-cel has the potential to be the first CD19-directed allogeneic cell therapy and having the FDA support on the manufacturing process that can be used for the pivotal trial is an extremely important milestone for Imugene as it improves the overall robustness and scalability of the product,” Imugene CEO and managing director Leslie Chong said.
Azer-cel therapy
Azer-cel is being studied in an ongoing multi-centre Phase 1b clinical trial in patients with non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL).
Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile, including promising results in diffuse large B cell lymphoma (DLBCL) patients who relapsed following CAR T.
IMU is manufacturing azer-cel at its state-of-the-art, 32,800-square-foot Good Manufacturing Practice (GMP) manufacturing facility in North Carolina.
With the FDA feedback on board, IMU will test the intended commercial azer-cel product in the clinic, in a potentially pivotal clinical trial.
Beyond using azer-cel in blood cancers, Imugene also intends to combine it with onCARlytics for the treatment of patients with solid tumours.