Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) has dosed the first patient in the Bruton Tyrosine Kinase inhibitor (BTKi) combination cohort of its Phase 1b azer-cel study, marking a key expansion of the company’s clinical program into a global market valued at about US$12 billion in 2025.
The patient, treated at Baylor University in Texas, has mantle cell lymphoma (MCL) and had previously failed BTKi therapy, a common treatment approach across several B-cell blood cancers.
Azer-cel is Imugene’s off-the-shelf allogeneic CAR T cell therapy being evaluated in multiple advanced blood cancers with high unmet medical need. The new cohort is testing the therapy in combination with a BTKi to assess safety and preliminary efficacy in patients who have relapsed following prior BTKi treatment.
Combination strategy targets patients with limited treatment options
The milestone broadens the potential clinical application of the azer-cel program and may help support future partnering opportunities, according to the company. Imugene said the additional cohort would also allow it to evaluate a wider range of B-cell malignancies and prioritise indications where azer-cel demonstrates the strongest clinical potential.
Chief executive officer Leslie Chong said the enrolment represented a meaningful step for the program.
“The enrolment of first patients into the BTKi combination cohort is a meaningful step in expanding the clinical scope of the azer-cel program. BTKi-relapsed patients represent a significant population with limited options, and we believe the concurrent combination approach has the potential to address this unmet need.
"We look forward to reporting safety and preliminary efficacy data as patients become evaluable, and to continuing to build the evidence base for azer-cel across B-cell malignancies.”
The ongoing Phase 1b study is being conducted across 10 US and five Australian sites and includes patients with follicular lymphoma, chronic lymphocytic leukaemia, marginal zone lymphoma, Waldenstrom macroglobulinemia and mantle cell lymphoma.
Imugene said further updates would be provided as additional patients become evaluable and more safety and efficacy data matures.