Imugene’s Azer-cel Trial Hits 81% Response Rate, Raises $25M to Fuel Growth

Clinical Breakthrough in Challenging Blood Cancers

Imugene Limited (ASX – IMU) has delivered encouraging clinical data from its Phase 1b trial of azer-cel, an allogeneic CAR T-cell therapy targeting CD19 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy demonstrated an overall response rate (ORR) of 81%, with 13 of 16 treated patients responding, including seven complete responses and six partial responses. These results mark a slight improvement from the 79% ORR reported just two months prior, underscoring the therapy’s potential in a heavily pre-treated patient population.

Notably, responses have been rapid and durable, with the average time to best response occurring within one to three months. One patient treated in early 2024 remains cancer-free after more than 18 months, while others maintain positive outcomes beyond five to fifteen months. This durability is particularly significant given the patients’ prior failure of multiple therapies, including autologous CAR T-cell treatments.

Expanding Horizons – New Patient Cohorts and Indications

Building on these promising results, Imugene has expanded the trial to include CAR T naïve patients with a broader spectrum of CD19-positive B-cell malignancies, such as follicular lymphoma, marginal zone lymphoma, Waldenström macroglobulinemia, and primary central nervous system lymphoma. Early data from this cohort show an 83% overall response rate in six evaluable patients, with half achieving complete responses. Faster enrolment in this group suggests a potentially expedited clinical development path.

The company is also exploring the use of azer-cel as a bridge to allogeneic stem cell transplant, aiming to consolidate responses and improve long-term remission rates beyond what conventional salvage therapies typically achieve.

Strategic Financial Moves and Pipeline Focus

On the financial front, Imugene successfully raised approximately $25 million through a $22.5 million institutional placement and a $2.42 million share purchase plan, priced at $0.33 per share. The capital raise was well supported by both domestic and international investors and included attaching options to incentivize participation. These funds will primarily support the initiation of a pivotal azer-cel trial in 2026 and extend the company’s cash runway into mid-2027.

Additionally, the company received a $5.9 million R&D tax refund for the 2024 financial year, further bolstering its development budget. Imugene also completed a 34 – 1 share consolidation earlier in the year to streamline its capital structure and enhance institutional appeal.

Reflecting a sharpened strategic focus, Imugene is moderating internal funding for its CF33 oncolytic virus and onCARlytics programs, exploring partnerships or licensing opportunities to advance these assets. This pivot aims to concentrate resources on near-term clinical and commercial milestones, particularly the azer-cel program.

Operational Efficiency and Outlook

Operationally, the company reported a 3% reduction in net cash used in operating activities compared to the prior quarter, with direct R&D expenses comprising 77% of operating costs. Staff costs have decreased by 10% quarter-on-quarter and 47% year-on-year, reflecting ongoing cost optimization efforts. Corporate and administration expenses rose slightly due to activities related to the share consolidation and capital raising but remain significantly lower than the previous year.

With $32.4 million in cash and cash equivalents at quarter-end, Imugene is well positioned to advance its clinical programs and maintain operational momentum. The company’s leadership emphasizes a commitment to transforming cancer treatment through innovative immunotherapies, supported by a growing body of clinical evidence.