Australian immuno-oncology company Imugene has dosed the first Australian subject in a Phase Ib trial of its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel).
The trial is evaluating azer-cel’s ability to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma.
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The subject was dosed at the Royal Prince Alfred Hospital in Sydney.
Azer-cel is intended to provide an off-the-shelf solution, potentially decreasing treatment times and increasing patient access compared with traditional autologous CAR T-cell therapies that involve a patient’s own cells.
Imugene CEO and managing director Leslie Chong said: “Achieving the 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, off the-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL.
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By GlobalData“We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites.”
Imugene recently reported ‘promising’ outcomes from trial sites in the US, where subjects have shown complete responses after failing various previous treatments, including autologous CAR T therapies.
Cohort B subjects, who received both lymphodepletion chemotherapy and interleukin-2 (IL-2), experienced particularly strong and sustained responses.
The ongoing azer-cel Phase Ib trial aims to assess azer-cel’s tolerability, safety and clinical activity in DLBCL individuals who have not responded to previous autologous CAR T-cell treatments.
It involves a combination of lymphodepletion chemotherapy and IL-2 to potentially ‘enhance’ azer-cel’s therapeutic effects.
It is estimated that more than 80,500 DLBCL cases are reported worldwide each year.
In May 2023, the US Food and Drug Administration (FDA) approved Imugene’s investigational new drug application for a Phase I trial of onCARlytics, an oncolytic virotherapy candidate for advanced or metastatic solid tumours.
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