Industry Opportunity: Addressing a Critical Unmet Need

The fight against blood cancer is evolving, and Imugene Limited (ASX:IMU) is at the forefront of this battle. With a new wave of promising results from its Phase 1b trial, Imugene’s allogeneic off-the-shelf CD19 CAR-T therapy, azer-cel, is demonstrating significant potential for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

DLBCL is one of the most common and aggressive forms of non-Hodgkin’s lymphoma, with over 30,000 new cases annually in the U.S. Many patients relapse after multiple lines of therapy, including autologous CAR-T treatment, leaving them with limited options. This is where azer-cel steps in.

New Data: More Patients Achieving Complete Responses

Two more patients in the trial have now achieved a Complete Response (CR), bringing the total to four out of seven in Cohort B.

“All four Complete Responses in this cohort were observed in patients who had already failed at least four prior treatments, including autologous CAR-T therapy,” said Dr. Paul Woodard, Chief Medical Officer at Imugene.

This latest data highlights azer-cel’s potential as a game-changing treatment for those who have exhausted traditional options.

Azer-cel Shows Promise in Difficult Cases

The trial’s results are particularly encouraging given the tough-to-treat nature of this patient population.

“The fact that we’re seeing responses in patients who previously had no success with other therapies suggests that azer-cel, when combined with IL-2, could provide a new lifeline,” Dr. Woodard added.

The longest durability of response is currently ongoing at 10 months, with further updates expected as the data matures.

Expanding Trial Sites in the U.S. and Australia

Imugene is actively expanding the trial, with 13 sites in the U.S. and up to five sites in Australia set to enrol patients.

“This is a critical step in ensuring that more patients can access this promising therapy,” Dr. Woodard said.

The company remains focused on continuing enrolment in Cohort B and evaluating the long-term durability of responses.

Industry Recognition and Next Steps

Imugene’s breakthrough with azer-cel is attracting attention from the global medical community. A poster presentation on the trial results was featured at the 2025 American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR) Tandem Meetings event, a key industry event highlighting the latest advancements in transplantation and cellular therapy.

“Sharing our data with the international scientific community allows us to further validate our findings and accelerate progress,” Dr. Woodard said.

Investors and industry observers will be watching closely as Imugene continues to advance its immunotherapy pipeline. With an increasing focus on allogeneic CAR-T therapies as a viable alternative to traditional approaches, the company is positioning itself as a leader in next-generation cancer treatments.