On January 3, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that the first Australian patient has been dosed in the Phase 1b clinical trial of its allogeneic CAR T-cell therapy azer-cel (azercabtagene zapreleucel), at the Royal Prince Alfred Hospital (RPAH) in Sydney (Press release, Imugene, JAN 3, 2025, View Source [SID1234649406]). The trial is focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), one of the most challenging and aggressive forms of non-Hodgkin’s lymphoma.
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Azer-cel is one of the few allogeneic CAR T-cell therapies currently being evaluated in Australia. Azer-cel offers an off-the-shelf alternative to traditional autologous CAR Tcell therapies, which require lengthy manufacturing processes involving a patient’s own cells. By utilising pre-manufactured donor T-cells, azer-cel has the potential to significantly shorten treatment timelines and expand accessibility for patients with limited options.
Imugene recently reported promising data from its US trial sites (see ASX announcement 2 September 2024), demonstrating the potential of azer-cel to deliver meaningful clinical outcomes. In the US cohorts, three patients achieved complete responses (CR) despite having relapsed following multiple prior treatments, including autologous CAR T therapies. Notably, patients treated in Cohort B – which includes lymphodepletion chemotherapy and interleukin-2 (IL-2) – have shown particularly robust and durable responses, with responses extending beyond 90 and 120 days.
Leslie Chong, Managing Director and CEO of Imugene, said: "Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease. The trial’s opening at RPAH in Sydney reflects our commitment to accelerating the development of innovative, offthe-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL. We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites."