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Highlights
- The first Australian site for the azer-cel Phase 1b trial is now open.
- Patient recruitment will start at Royal Prince Alfred Hospital in Sydney in November 2024.
- The azer-cel Phase 1b trial is currently the only allogeneic CAR T-cell trial actively recruiting in Australia.
- Trial data from US sites show promising results, with three patients achieving complete responses after failing multiple previous treatments.
Shares of Imugene Limited (ASX:IMU) rose nearly 4.44% to AU$0.047 each on Friday morning following an encouraging update on the progress of its azer-cel (azercabtagene zapreleucel) Phase 1b clinical trial.
The company has opened its first Australian site for the trial, with patient recruitment set to begin in November 2024 at Royal Prince Alfred Hospital in Sydney, marking a significant milestone in the development of the off-the-shelf allogeneic CAR T-cell therapy.
This will be the only allogeneic CAR T-cell trial actively recruiting in Australia. The trial is focused on relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Azer-cel presents a promising option for patients who have not responded to other treatments, including autologous CAR T-cell therapies.
This "off-the-shelf" therapy uses donor T-cells, which are manufactured in advance and ready for use, enabling quicker treatment and broader accessibility compared to autologous CAR T-cell therapies that require harvesting and engineering a patient’s own T-cells. Azer-cel targets the CD19 protein.
Early data from the trial at US sites show encouraging results, with three patients achieving complete responses after failing multiple prior therapies, including autologous CAR T.
Notably, in Cohort B, two out of three patients who received a combination of azer-cel, lymphodepletion (chemotherapy), and interleukin-2 (IL-2) sustained complete responses lasting beyond 90 and 120 days. These preliminary results highlight the potential of Azer-cel as a meaningful alternative for patients with limited treatment options.
