Four Complete Responses in Imugene’s Azer-cel Trial Drive FDA Fast Track Status

Clinical Progress Bolsters Imugene’s Immuno-Oncology Pipeline

Imugene Limited (ASX: IMU) has delivered a robust quarterly update for the period ending 31 March 2025, highlighting significant clinical and regulatory milestones that underscore its advancing immuno-oncology portfolio. The company’s Phase 1b trial of azer-cel, an allogeneic off-the-shelf CAR T-cell therapy targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL), reported two additional complete responses, bringing the total to four out of seven evaluable patients in Cohort B. This 57% complete response rate is particularly notable given these patients had exhausted multiple prior therapies, including autologous CAR T-cell treatments.

The trial regimen combines azer-cel with lymphodepletion chemotherapy and low-dose interleukin-2 (IL-2), aiming to enhance CAR T-cell efficacy. Impressively, the longest ongoing complete response approaches 12 months, suggesting durable clinical benefit. These findings were presented at the 2025 ASTCT Tandem Meetings, emphasizing azer-cel’s improved pharmacokinetic profile without compromising safety.

Regulatory Momentum with FDA Fast Track Designation

In a pivotal regulatory development, the US Food and Drug Administration (FDA) granted Fast Track Designation to azer-cel for DLBCL treatment. This status is designed to accelerate the development and review of therapies addressing serious conditions with unmet medical needs. For Imugene, this means more frequent FDA interactions, rolling submissions, and eligibility for priority review pathways, potentially shortening the time to market for azer-cel.

Further clinical progress includes dosing the first Australian patient at Royal Prince Alfred Hospital in Sydney and receiving clearance to escalate dosing in the intravenous combination arm of the onCARlytics Phase 1 OASIS trial. This trial targets advanced or metastatic solid tumors using a CD19-expressing oncolytic virus alone or combined with the bispecific antibody blinatumomab, reflecting Imugene’s multi-pronged approach to immunotherapy.

Strengthening Intellectual Property and Leadership

Imugene fortified its patent portfolio during the quarter with a Notice of Allowance for onCARlytics in China and granted patents for its CF33 oncolytic virotherapy in India and PD1-Vaxx immunotherapy in Australia. These patents extend protection through to 2038, securing competitive positioning in key global markets.

On the corporate front, the appointment of Darren Keamy as Chief Financial Officer and Company Secretary adds seasoned leadership with over 25 years of biopharmaceutical finance and governance experience. Keamy’s track record includes scaling Clinuvel Pharmaceuticals from a startup to a multinational, a valuable asset as Imugene navigates clinical and commercial milestones.

Financial Position Supports Continued R&D Investment

Financially, Imugene strengthened its balance sheet by raising A$20 million through senior, unsecured, zero-coupon convertible notes issued to CVI Investments, Inc. These notes offer conversion flexibility without interest costs, maturing in five years. Additionally, the company received an R&D tax refund of approximately A$11.7 million for the 2023 financial year, further bolstering cash reserves.

At quarter-end, Imugene held A$36.25 million in cash and equivalents, supporting ongoing clinical trials and development activities. Operating cash outflows increased to A$16.8 million, reflecting intensified R&D efforts, including manufacturing costs for azer-cel clinical supply. Direct research and development expenses accounted for 62% of total costs, underscoring the company’s commitment to advancing its pipeline.

Overall, Imugene’s quarterly report paints a picture of a clinical-stage biotech company making tangible strides in immuno-oncology, backed by regulatory progress, patent protections, and a solid financial foundation. The coming quarters will be critical as clinical data matures and regulatory interactions advance toward potential approvals.