Imugene (ASX: IMU) has announced positive feedback from the US Food and Drug Administration (FDA) on a manufacturing process for lead candidate azer-cel (azercabtagene zapreleucel or allogeneic CD19 CAR T) for the treatment of patients with relapsed blood cancers.
The therapy will be the basis of a pivotal clinical trial starting in 2024 and potentially be used in commercial production.
The improved manufacturing process will allow for increased robustness, consistency and scalability.
Clinically meaningful activity
Azer-cel is currently being studied in an ongoing multi-centre Phase 1b clinical trial in patients with non-Hodgkin’s lymphoma and acute lymphocytic leukemia.
It 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 therapy.
Imugene chief executive officer Leslie Chong said the intended commercial azer-cel product will be tested and utilised in a potential pivotal clinical trial.
“Azer-cel has the potential to be the first CD19-directed allogeneic cell therapy,” she said.
“Having FDA support on the manufacturing process which can be used for the pivotal trial is an extremely important milestone for us as it improves the overall robustness and scalability of the product.”
Azer-cel is being marketed as a potential first-in-class allogeneic CD19 CAR T candidate for a growing population of CAR T-relapsed patients with DLBCL.
It is being manufactured at a state-of-the art, 3047 square metre facility in North Carolina.
Beyond blood cancers, the lead candidate will be combined with onCARlytics for the treatment of patients with solid tumours.
Global exclusive licence
In August, Imugene inked an agreement with US-based Precision Biosciences to acquire a global exclusive license to Precision’s azer-cel allogeneic CD19 CAR T cell therapy program.
The acquisition was funded by a $65 million capital raising aimed at supporting its global growth plans.
It will allow Imugene to add azer-cel to its own pipeline of developments and create the foundation for a novel and broadened approach to cell therapy.
“Azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing CD19,” Ms Chong said at the time.
“We are thrilled about the potential benefit for patients from the combination of these two technologies.”