Results continued to flow through Imugene Ltd’s immuno-oncology pipeline during the March 2025 quarter, which was marked by positive clinical outcomes, regulatory milestones, expanded patent protection and strengthened funding.
The company continues to move forward on multiple fronts and retains a strong funding position to do so.
Azer-cel trial continues
A key highlight was the continued progress in the Phase 1b clinical trial of azer-cel, an off-the-shelf allogeneic CAR T-cell therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Two new complete responses were reported in Cohort B, bringing the total to four of seven evaluable patients.
These responses were achieved in heavily pre-treated patients, including those previously treated with autologous CAR T-cell therapies.
In recognition of its potential to address a critical unmet medical need, azer-cel received Fast Track Designation from the US Food and Drug Administration, which may accelerate development and regulatory review.
The first Australian patient was dosed at Royal Prince Alfred Hospital in Sydney, with recruitment underway at sites across the US and Australia.
OnCARlytics dose escalation cleared
Further progress was made on the onCARlytics program, with clearance granted to escalate dosing in the intravenous arm of the Phase 1 OASIS trial.
This study evaluates Imugene’s CD19-expressing oncolytic virus in combination with blinatumomab for advanced solid tumours.
During the quarter, Imugene secured additional patent protection for its platform technologies, including allowances in China and India for onCARlytics and CF33 oncolytic virotherapy and a new Australian patent for its PD1-Vaxx immunotherapy.
Financially, the company strengthened its cash position with a A$20 million zero-coupon convertible note issue to CVI Investments Inc, part of a broader A$46 million funding arrangement.
A further A$11.7 million was received via the Australian R&D tax incentive refund.
Imugene ended the quarter with A$36.25 million in cash and equivalents.
Operating cash outflows were A$16.98 million, with 62% directed to research and development, primarily for the azer-cel program.
The company also appointed Darren Keamy as Chief Financial Officer and Company Secretary, enhancing its financial leadership with over 25 years of industry experience.