Imugene has reported another encouraging result from the concurrent BTKi cohort of its azer-cel Phase 1b trial, announcing a third response in patients treated with the off‑the‑shelf allogeneic CAR T therapy.
The company said the latest responder is a patient with follicular lymphoma who had previously progressed on Bruton Tyrosine Kinase inhibitor therapy and achieved a partial response at the Day 28 assessment.
Azer-cel, an allogeneic CAR T derived from healthy donor T cells and designed to target CD19, can be administered within days without the three-to-six week manufacturing lead time required for autologous products.
Imugene has been testing whether dosing azer-cel concurrently with a BTKi can restore or enhance therapeutic activity in patients whose disease has relapsed on or become refractory to BTKi therapy. To date, five patients have been dosed in this concurrent BTKi cohort across sites in the United States and Australia.
Follicular lymphoma is the most common indolent B‑cell lymphoma. While many patients respond to initial treatment, relapses are common and durable options remain limited for those who develop resistance. BTK inhibitors are a standard treatment across multiple B‑cell malignancies and represent a large global market, estimated at about US$12 billion in 2025, but a significant proportion of patients eventually progress on these agents.
Both follicular lymphoma patients treated so far in the concurrent BTKi cohort have now demonstrated responses to the combined approach of azer-cel plus a BTKi.
Paul Hopper, Executive Chairman of Imugene, said, "An additional response in the concurrent BTKi cohort, and the second in Follicular Lymphoma, adds to the early signal we are seeing in patients who have progressed on BTKi therapy. Each additional response strengthens our confidence in the rationale for dosing azer-cel concurrently with a BTKi and supports our belief that this approach can address a clear unmet need across a range of blood cancers."
The broader azer-cel Phase 1b trial is an open‑label, multicentre study in the U.S. and Australia enrolling patients with a variety of non‑Hodgkin lymphomas and related B‑cell malignancies, including follicular lymphoma, chronic lymphocytic leukemia, marginal zone lymphoma, Waldenström macroglobulinemia and mantle cell lymphoma. Treatment with azer-cel alongside lymphodepletion and IL‑2 has already produced meaningful clinical responses across multiple indications, including several complete responses in the concurrent BTKi cohort, while the safety profile has been described as manageable and generally well tolerated.
Imugene says patient enrolment is ongoing and further updates will be provided as the dataset matures.
The company also announced that its Chief Executive Officer and Managing Director, Leslie Chong, has stepped down effective immediately, for personal reasons, after nearly 11 years of service.
Ms Chong said, “I am incredibly proud of the company that our Board, our management team and I have built since 2015. I am deeply grateful to the patients who participate in our clinical trials and to the investigators, physicians, healthcare professionals and investors whose commitment makes the development of novel therapies possible."
Mr Hopper said, "Leslie has been a significant part of the Imugene story. She joined us in the early stages of our growth and has played a pivotal role in building the Company into a global clinical-stage biotechnology company. It has been a privilege to work alongside Leslie over the past decade, and on behalf of the Board, I thank her for her dedication and significant contribution to Imugene and wish her every success for the future."
