Imugene (ASX:IMU) has reported encouraging early clinical results from its ongoing Phase 1b study of Azer Cel, an off-the-shelf CAR T cell therapy designed to treat several advanced blood cancers.
The company said the data point to strong response rates in certain lymphoma and leukemia subtypes and suggest growing clinical interest in the therapy as patient enrolment accelerates.
The Sydney-based immuno-oncology company said the therapy produced a 100 per cent overall response rate among patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. All four patients in that group achieved partial responses after a median of three prior lines of treatment. In this disease setting, complete responses are uncommon and partial responses alone have historically been sufficient to support regulatory approvals.
The trial also produced strong results in patients with marginal zone lymphoma. Four of five patients responded to treatment, delivering an overall response rate of 80 per cent. Among those participants, three achieved complete responses, and one experienced a partial response after at least two prior lines of therapy.
These early signals come from a broader multi-indication basket trial that is evaluating Azer Cel across several advanced B-cell malignancies with significant unmet medical need. By testing the therapy across multiple cancer subtypes simultaneously, the company aims to identify where the treatment demonstrates the strongest clinical activity and potentially accelerate development toward market approval in the most promising indications.
The study currently includes patients with primary central nervous system lymphoma, diffuse large B-cell lymphoma, and Waldenström macroglobulinemia. The trial also focuses on chronic lymphocytic leukemia and marginal zone lymphoma, particularly among patients who have already received targeted therapies such as BTK inhibitors or chemoimmunotherapy.
Clinical data from these cohorts are still maturing, and patient enrolment continues across sites in the United States and Australia.
According to the company, enrolment in the CAR T naive cohort is progressing faster than in earlier groups of patients who had previously relapsed after CAR T therapy, reflecting increased investigator interest in an allogeneic approach that can be delivered without the need to manufacture personalised cells for each patient.
Imugene has also amended the study protocol to explore a combination strategy that pairs Azer Cel with Bruton tyrosine kinase inhibitors, a class of drugs that has become the standard first-line therapy for many B-cell cancers. The new arm of the trial will evaluate patients who have previously failed BTK inhibitor therapy and will include individuals with mantle cell lymphoma. Researchers will assess both safety and early signs of efficacy in these difficult-to-treat populations.
Chief executive officer Leslie Chong said the emerging activity across multiple lymphoma subtypes highlights the potential breadth of Azer Cel in areas where patients have limited treatment options. She noted that combining the therapy with BTK inhibitors may expand the program's clinical reach and strengthen its position in the evolving treatment landscape for blood cancers.
Azer Cel is an allogeneic CAR T therapy targeting CD19, a protein commonly expressed on malignant B cells. Unlike traditional CAR T treatments that require a patient’s own cells to be engineered individually, an allogeneic therapy is designed to be manufactured in advance and delivered off the shelf, potentially allowing faster treatment and broader access.