On November 10, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported dosing of the first patient in a Phase 1b clinical trial using azer-cel (allogeneic off-the-shelf CD19 CAR T, a type of cell therapy), manufactured and supplied from Imugene’s state-of-the-art facility in North Carolina (Press release, Imugene, NOV 10, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/9f58067b-3acc-8a6b-d0ab-e67d1ad1d5c0/02738212.pdf [SID1234637442]).
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Following completion of the Phase 1b study there is potential to start a registrational study in 2024 and become the first approved allogeneic CAR T cell therapy for cancer. The patient who was dosed at Banner Health (Phoenix Arizona) suffers from a difficult to treat sub-set of NHL called Diffuse-Large B-cell lymphoma (DLBCL).
Dr Paul Woodard, Imugene’s Chief Medical Officer said, "Patients with DLBCL who have relapsed after autologous CART therapy have limited therapeutic options and are an unmet medical need. New and effective therapies are needed for these patients."
As announced in September 2023, Imugene received positive feedback from the FDA on the azer-cel manufacturing process to be used in the registrational (to-market) clinical trial, and potentially for manufacturing of the commercial drug product. Imugene’s manufacturing facility is a state-of-the-art GMP (Good Manufacturing Process) site where the proprietary next generation azer-cel process has evolved into a potential firstin-class cell therapy drug.
Imugene MD & CEO, Ms Leslie Chong said, "It is a great credit to our team that the Phase 1b study has been initiated and the first patient dosed, in under three months since acquiring the technology."
The Phase 1b allogeneic (allo) CAR T study is an ongoing multi-centre Phase 1b clinical trial in patients with non-Hodgkin’s lymphoma (NHL) and B-cell acute lymphocytic leukemia (ALL). Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile, including promising results in DLBCL patients who relapsed following CAR T.
Beyond using azer-cel in blood cancers, in the future it will also be combined with Imugene’s own onCARlytics for treatment of patients with solid tumours, opening a potentially large market for azer-cel in the 90% of oncology not beyond blood cancers.