Imugene Logs Third Partial Response in Azer-cel Phase 1b Trial

Third Response in BTKi-Resistant Follicular Lymphoma Patients

Imugene Limited (ASX:IMU) has reported a third patient response in the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of its azer-cel Phase 1b clinical trial, underscoring early signs of efficacy in a challenging treatment landscape. The latest partial response (PR) was recorded in a Follicular Lymphoma (FL) patient who had previously progressed on BTKi therapy, marking the second FL patient in this cohort to respond to the combination of azer-cel and BTKi.

Follicular Lymphoma remains a high unmet need despite initial treatment successes, as many patients relapse or develop resistance. BTKi therapies, which address a global market worth approximately US$12 billion, are standard for multiple B-cell malignancies but face limitations due to resistance over time. Imugene’s strategy to dose azer-cel concurrently with BTKi aims to restore or enhance therapeutic activity in patients who have exhausted BTKi options.

Azer-cel’s Off-the-Shelf CAR T Advantage

Azer-cel (azercabtagene zapreleucel) is an allogeneic CAR T cell therapy targeting CD19, designed to offer a ready-to-administer alternative to autologous CAR T therapies that require lengthy manufacturing lead times. The Phase 1b trial spans ten US and five Australian sites and includes patients with a range of Non-Hodgkin lymphomas, such as FL, chronic lymphocytic leukemia, marginal zone lymphoma, and mantle cell lymphoma.

So far, five patients have been dosed in the concurrent BTKi cohort, with the safety profile described as manageable and generally well tolerated. The trial has previously reported complete responses in BTKi-resistant patients, bolstering confidence in this combination approach.

Leadership Change as CEO Leslie Chong Steps Down

In a significant leadership development, Imugene announced the immediate resignation of CEO and Managing Director Leslie Chong, who has served the company for nearly 11 years. Ms Chong cited personal reasons for her departure but expressed pride in the company’s progress and confidence in its future, particularly highlighting the promising clinical data emerging from the azer-cel program.

The Board has commenced a search for a new CEO, with Executive Chairman Paul Hopper assuming oversight of the senior leadership team during the transition. Hopper paid tribute to Chong’s pivotal role in shaping Imugene into a global clinical-stage biotechnology company and acknowledged her substantial contributions to its strategic and clinical development.

What Comes Next for Imugene

Imugene’s dual headlines of clinical progress and executive change present a mixed but pivotal moment. The continued enrolment and emerging responses in the BTKi cohort signal potential momentum for azer-cel in addressing resistant blood cancers. Meanwhile, leadership transition introduces uncertainty about strategic continuity and execution.

Investors will be watching closely for updates on the new CEO appointment and any shifts in corporate strategy or clinical development priorities. The company’s ability to maintain trial momentum and capitalise on its early clinical signals will be critical as it navigates this leadership change.