Clinical-stage immuno- oncology company, Imugene (ASX:IMU), has announced the opening of the first Australian site for its azer-cel Phase 1b clinical trial.
The Royal Prince Alfred Hospital in Sydney will begin patient recruitment in November 2024, marking another significant milestone in the development of this promising off-the-shelf allogeneic CAR T- cell therapy.
This trial will be one of the only actively enrolling allogeneic CAR T-cell clinical trial in Australia, focusing on relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a challenging form of non-Hodgkin’s lymphoma. Azer-cel represents a promising therapeutic option for patients whose cancers have not responded to other treatments, including autologous CAR T-cell therapies.
Azer-cel is an allogeneic, off-the-shelf CAR T-cell therapy that targets CD19, a protein commonly found on the surface of B-cells, including cancerous cells in DLBCL.
Unlike traditional autologous CAR T therapies, which require harvesting and engineering a patient’s own T-cells, azer-cel uses donor T-cells, which are pre-manufactured and ready for use. This approach allows for quicker treatment and broader availability compared to autologous therapies that have long production times and logistical challenges.
Data to date from the trial, which has been dosing patients at US centres, has demonstrated promising results with three patients achieving complete responses (CR) even after failing multiple previous treatments, including autologous CAR T.
In particular, patients in Cohort B of the trial, who received a combination of azer-cel, lymphodepletion (chemotherapy), and interleukin-2 (IL-2), showed robust clinical activity. Two out of three of the evaluable patients in this cohort experienced complete responses, with the durability of these responses extending beyond 90 and 120 days. These early results suggest that azer-cel could offer a meaningful alternative for patients with limited treatment options.
“We’re proud to be able to bring this trial to Imugene’s home country and provide an opportunity for Australian patients to benefit from this unique technology,” said Imugene’s Managing Director and CEO Leslie Chong.
“This is the first of up to five sites we plan to open in Australia, as we seek to speed up enrolment and deliver improved outcomes in this form of blood cancer.”
