• Azer-cel Phase 1b trial records 81% overall response rate in relapsed/refractory DLBCL
• Trial expanded to include CAR T-naive indications like rare lymphomas
• $25 million raised through institutional placement and share purchase plan

Imugene Limited, a clinical-stage immuno-oncology company, has reported positive results from its ongoing Phase 1b clinical trial of Azer-cel (azercabtagene zapreleucel), an allogeneic, off-the-shelf CD19 CAR T-cell therapy. The trial has recorded an overall response rate (ORR) of 81% in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Of the sixteen patients treated so far, thirteen have responded to therapy, including seven complete responses and six partial responses. The responses have been both rapid and durable, with the average time to best response occurring within one to three months. The first patient dosed in 2024 with Azer-cel and IL-2 remains cancer-free for more than eighteen months, while additional responders are maintaining outcomes beyond five, five, six, and fifteen months. The trial has also expanded to include and treat CAR T-naive patients diagnosed with a broad range of Non-Hodgkins lymphomas, including primary central nervous system lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia, follicular lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma. During the quarter, the company successfully completed a $22.5 million institutional placement and a $2.42 million share purchase plan, raising a total of $24.9 million. The proceeds will primarily fund Imugene's Azer-cel program through the initiation of a pivotal clinical trial in 2026, while also extending the company's funding runway into mid-2027 and supporting general working capital needs.