Imugene Ramps Up Clinical Momentum Amid Strong Trial Results and ASX 200 Positioning

May 01, 2025 03:55 PM AEST | By Team Kalkine Media

Imugene Ramps Up Clinical Momentum Amid Strong Trial Results and ASX 200 Positioning — Image source: Shutterstock

Promising Outcomes for Azer-cel Therapy

The azer-cel program—an allogeneic CAR T-cell therapy tailored for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)—recorded notable clinical progress in its Phase 1b trial. During the quarter, two additional complete responses were reported in Cohort B, totalling four of seven evaluable patients.

These results are particularly compelling as they were observed in heavily pre-treated individuals, including those who had undergone autologous CAR T-cell therapies. Such performance has underlined azer-cel’s therapeutic potential, prompting the US Food and Drug Administration to award it Fast Track Designation. This designation could expedite both the development and regulatory review process.

Recruitment for the ongoing trial is now underway across Australia and the US, with the first Australian patient recently dosed at Sydney’s Royal Prince Alfred Hospital.

onCARlytics and Patent Expansion Drive Platform Growth

Beyond azer-cel, Imugene (ASX:IMU) also progressed with its onCARlytics program. The Phase 1 OASIS trial investigating the intravenous administration of its CD19-expressing oncolytic virus in combination with blinatumomab for solid tumours received clearance for dose escalation, signifying another step forward in clinical validation.

The company also expanded its global intellectual property footprint during the quarter. Patents for its CF33 oncolytic virotherapy and onCARlytics platform were granted in China and India, while a new Australian patent was issued for PD1-Vaxx immunotherapy.

Financial Position Strengthened for Continued Advancement

Imugene bolstered its funding capability with a A$20 million zero-coupon convertible note from CVI Investments Inc., forming part of a broader A$46 million financing package. Additionally, the company received A$11.7 million via the Australian R&D tax incentive, closing the quarter with A$36.25 million in cash and equivalents.

With A$16.98 million in operating cash outflows—62% of which was dedicated to R&D—the majority of capital was channelled into clinical development, especially for azer-cel. The company also reinforced its leadership team by appointing Darren Keamy as Chief Financial Officer and Company Secretary, adding strategic financial expertise.

Imugene’s continued innovation, capital strength, and inclusion in the ASX dividend stocks discussion positions it as a dynamic biotech contender within the ASX 200 ecosystem.

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