Imugene's stock surged on promising Phase 1b results. Picture Getty
Health & Biotech
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.
Emyria (ASX:EMD) also shared encouraging interim results from its MDMA-assisted therapy (MDMA-AT) for Post-Traumatic Stress Disorder (PTSD).
The initial analysis of eight patients shows all of them experiencing significant improvement in their PTSD symptoms, with an average reduction of 33 points on the PCL-5 scale, a key measure of PTSD severity.
Patients also reported a boost in their quality of life, with an average improvement of 22 points on the ReQoL scale.
The program, which began in October 2023, has so far enrolled 13 patients, with eight having completed the treatment.
The results indicate that MDMA-AT not only significantly reduces PTSD symptoms but also enhances overall well-being.
Emyria is now working on expanding this program, aiming to enrol 70 patients, and is actively pursuing opportunities with private hospitals and third-party payers to widen access and secure reimbursement.
The findings will be presented by Dr Jon Laugharne at the WA Branch Conference of the Royal Australian and New Zealand College of Psychiatrists on September 6 and 7.
Emyria says it plans to use its existing revenues to support program expansion and operational growth.
Health & Biotech
Health & Biotech
Health & Biotech
