Imugene Ltd (ASX:IMU, OTC:IUGNF) has launched a Phase 1b clinical trial at the Royal Prince Alfred Hospital in Sydney, dosing the first Australian patient with its allogeneic CAR T-cell therapy azer-cel (azercabtagene zapreleucel) treatment.
The trial will focus 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.
Azer-cel offers an off-the-shelf alternative to traditional autologous CAR T-cell therapies, which require lengthy manufacturing processes involving a patient’s own cells, reducing both treatment timelines and cost.
Developing off-the-shelf immunotherapies
“Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease,” Imugene managing director and CEO Leslie Chong said.
“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.
“We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites.”
IMU’s trials in the US have produced promising data indicating azer-cel has potential to deliver meaningful clinical outcomes.
Three patients achieved complete responses (zero signs of cancer present in the body) despite having relapsed following multiple prior treatments, including autologous CAR T therapies.
Patients treated in Cohort B, which includes lymphodepletion chemotherapy and interleukin-2 (IL-2), have shown particularly robust and durable responses, extending beyond 90 and 120 days.
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive subtype of non-Hodgkin’s lymphoma (NHL), accounting for over 80,500 cases globally each year.
A significant number of patients affected by the cancer do not respond to treatment or relapse following it, highlighting a critical unmet need in oncological treatment.