Imugene reports advances in Azer-Cel trial, stock soarsImugene...

Imugene reports advances in Azer-Cel trial, stock soars

Imugene (ASX:IMU) has soared by 27% this morning after announcing significant progress in its Phase 1b clinical trial of azer-cel.

Azer-cel is an allogeneic CAR T-cell therapy designed to treat/diffuse large B-cell lymphoma (DLBCL).

In the trial, patients were divided into two cohorts.

Cohort A included six patients who received azer-cel along with chemotherapy (lymphodepletion); while Cohort B comprised four patients who were treated with azer-cel, chemotherapy, and interleukin 2 (IL-2).

IL-2 is a cytokine that helps T-cells, which are crucial in the immune response against cancer.

The trial has seen encouraging outcomes, with three patients achieving complete responses.

Specifically, the first two patients in Cohort B have maintained their complete responses for more than 120 and 90 days, respectively. The third patient in Cohort A also achieved a complete response.

Currently, all four patients in Cohort B are still participating in the trial, and additional patients will be enrolled in this cohort.

All patients involved in the trial had previously undergone four to five lines of therapy, including prior autologous CAR T treatments. This highlights the significant challenge and unmet need in this disease.

The promising results from Cohort B, where IL-2 was added to the regimen, are particularly significant, noted Imugene, and will be considered in the development of the potential FDA Phase 2/3 registration trial.

The trial is being conducted across 15 leading cancer centres in the US, with plans to expand to up to five sites in Australia.

The next steps will be to enrol additional patients in Cohort B and closely monitoring the durability of responses.

If successful, azer-cel could become the first approved allogeneic CAR T-cell therapy for blood cancer.

DLBCL is an aggressive type of non-Hodgkin’s lymphoma and is the most common form of this disease.

With about 80,500 cases annually and around 30,000 new cases each year in the US, there remains a significant medical need, especially for patients whose cancer has relapsed or is resistant to existing treatments.