Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) reported further positive clinical results during the December 2025 quarter, with its azer-cel Phase 1b trial achieving an Overall Response Rate of 82% in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Of the 17 evaluable patients treated, 14 responded to therapy, including seven complete responses and seven partial responses. The company said responses were rapid, with best responses typically observed within one to three months, and noted that the first patient dosed in 2024 remains cancer-free more than 21 months later.
Patients enrolled in the study represent a heavily pre-treated population, with many having failed multiple prior lines of therapy, including autologous CAR T treatments. Imugene said the data supports azer-cel’s potential as a treatment option for patients with limited alternatives, including as a bridge to allogeneic stem cell transplant in responding patients.
CAR T-naïve cohort expands pipeline opportunity
During the quarter, Imugene expanded recruitment to include CAR T-naïve patients across a broader range of CD19-positive B-cell malignancies, including follicular lymphoma, marginal zone lymphoma and chronic lymphocytic leukaemia.
Early data from this cohort showed an Overall Response Rate of 83%, with five of six evaluable patients responding and a 50% complete response rate. The company said enrolment in this cohort is progressing faster than in the relapsed DLBCL group, supporting broader development potential for azer-cel.
Imugene also reported a positive outcome from a meeting with the US Food and Drug Administration, which validated key aspects of the azer-cel development strategy and provided a clear regulatory pathway toward a pivotal trial. The FDA endorsed the proposed dosing regimen, target patient population and dual endpoint strategy for accelerated and full approval.
Strategic focus sharpens as costs fall
During the quarter, Imugene entered a collaboration with JW Therapeutics to evaluate a combination therapy using its onCARlytics oncolytic virus with JW’s CD19 CAR T therapy in China. The collaboration is expected to reduce capital requirements for the onCARlytics program and allow greater focus on advancing azer-cel.
On the financial front, Imugene amended its $20 million convertible notes to improve cash flow flexibility and reduce near-term pressure, while also implementing significant cost reductions following the sale of its manufacturing facility. The company said operating costs for the current financial year are expected to be about 50% lower than the prior year.
At December 31, 2025, Imugene held $14.1 million in cash and cash equivalents, with operating cash outflows of $13.4 million for the quarter, largely driven by research and development activities.