Company Interview / Blood cancer trial delivers 75% response rate, eyes US phase 2 approval

Key Points:

Imugene (ASX:IMU) records a 75% overall response rate in its blood cancer therapy trialAllogeneic therapy offers off-the-shelf treatment for aggressive blood cancersUS and Australian sites conducting ongoing clinical trialsPlans underway to seek pivotal registration with the FDA based on new data

Imugene (ASX:IMU) is progressing with its US trial for a blood cancer therapy, targeting patients with diffuse large B-cell lymphoma (DLBCL) who have failed at least three prior treatments, including autologous Car-T therapies. Leslie Chong states that the trial has added five new patients, all of whom responded meaningfully to the treatment. Among these, two experienced a complete response—where their scans show no detectable cancer—while three achieved at least a 50% reduction in their disease. This brings the overall response rate in the study so far to 75%.

Leslie highlights the therapy’s allogeneic nature, which differentiates it from autologous approaches. While autologous treatments involve engineering a patient's own T cells, allogeneic therapies use donor T cells that are pre-prepared and ready for use on demand. This off-the-shelf availability is seen as a significant advantage for patients whose disease progresses rapidly.

Imugene’s trial is currently operating at 13 sites in the United States, with six additional locations to open in Australia. Leslie notes the next step involves presenting data to the FDA for potential pivotal registration, offering hope for accelerated approval. Despite the share price challenges this year, the company indicates a cash runway extending at least 12 months.