Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company developing immunotherapies, has announced promising results from its Phase 1b study of azer-cel, an off-the-shelf, allogeneic CAR T cell therapy. The trial is evaluating azer-cel across multiple advanced B-cell malignancies.
The update highlights a 100% Overall Response Rate (ORR) in patients with Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL). This was observed in patients who had received a median of three or more prior lines of therapy, with all four patients achieving Partial Responses (PR). Additionally, an 80% ORR was seen in Marginal Zone Lymphoma (MZL) patients, with three out of five achieving Complete Responses (CR) and one patient achieving a PR, after receiving a median of two or more prior lines of therapy.
The azer-cel Phase 1b CAR T-naïve cohort is structured as a multi-indication basket trial, potentially streamlining the registrational pathway. Imugene is prioritising indications where azer-cel demonstrates the most promising activity. The trial includes Primary Central Nervous System Lymphoma (PCNSL), Diffuse Large B-Cell Lymphoma (DLBCL), and Waldenström’s Macroglobulinemia (WM).
Imugene has also amended the Phase 1b protocol to evaluate azer-cel in combination with a BTK inhibitor (BTKi) and to include patients with mantle cell lymphoma (MCL). CEO Leslie Chong noted the potential breadth of azer-cel and the opportunity to expand the clinical scope of the program, particularly for patients who have failed prior BTKi therapy. Patient enrolment in the Phase 1b azer-cel trial is ongoing at sites in the US and Australia.
