Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, today announced a significant milestone in its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel). Imugene is dedicated to developing allogeneic CAR T cell therapies for blood cancers, with azer-cel being an off-the-shelf treatment targeting CD19. The company reported that the first patient in the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort achieved a complete response (CR) at their Day 28 assessment.
The patient, suffering from Follicular Lymphoma (FL), had previously received and failed BTKi therapy, highlighting a population with limited remaining treatment options. FL is the most common indolent B-cell lymphoma, and while many patients respond to initial treatment, relapse over time is common, leading to a high unmet medical need. The global market for BTKi therapy reached approximately US$12.0 billion in 2025, with a significant proportion of patients eventually developing resistance.
This specific cohort evaluates whether concurrent dosing of azer-cel with a BTKi can restore or enhance therapeutic activity in patients who have relapsed on or are refractory to BTKi therapy. Leslie Chong, Managing Director and CEO of Imugene, stated that this initial data provides further confidence in azer-cel’s potential for patients who have exhausted standard treatment options. She added that given the widespread use of BTKi therapies, this combination approach could represent a meaningful development pathway for azer-cel.
To date, four patients have been dosed in the concurrent BTKi combination cohort, including the first with mantle cell lymphoma. Patient enrolment continues across ten US and five Australian sites for the azer-cel allogeneic CAR T trial. Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy derived from healthy donor T cells, ready for administration within days, bypassing the lengthy manufacturing lead times typically required for autologous CAR T products.
