Imugene activates Australian site for Phase II bowel cancer vaccine trial

Imugene Ltd (ASX:IMU, OTC:IUGNF) has activated its first Australian site in the Phase II Neo-POLEM trial, expanding the clinical investigation of its PD1-Vaxx immunotherapy for a difficult-to-treat form of colorectal cancer.

The investigator-sponsored study trial (IST) is now recruiting patients in both Australia and the United Kingdom to assess PD1-Vaxx – a neoadjuvant B-cell vaccine designed to trigger an immune response against PD-1 – in patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer.

This genetic subtype accounts for about 15% of cases of colorectal cancer, also known as bowel cancer – the third most common cancer – and is considered more responsive to immunotherapy.

Focus on tumour response ahead of surgery

The trial will evaluate how PD1-Vaxx performs when administered before surgery, aiming to determine major pathological response – a measure of tumour shrinkage following treatment.

Secondary outcomes include overall survival, objective response rate, biomarker activity and safety.

Led by the Cancer Research UK Southampton Clinical Trials Unit, the Neo-POLEM study is being run in partnership with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trials Group (AGITG).

“This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population,” the company said.

Imugene CEO and managing director Leslie Chong welcomed the progress of the international trial.

“We’re very pleased to see this Neo-POLEM IST open and enrolling in Australia,” she said. “PD1-Vaxx has the potential to offer a durable immune response and improve treatment outcomes, and we look forward to further progress in both Australia and the UK.”

Global burden and unmet need

Colorectal cancer is the third most common cancer worldwide, with more than 1.2 million new cases diagnosed each year. About 80% of patients present with localised and resectable disease, yet the global mortality rate remains around 50%.

Imugene sees significant potential in targeting the dMMR/MSI-high subgroup with immunotherapy, offering an alternative approach to traditional chemoradiation that may enhance long-term outcomes.

Neo-POLEM joins a growing slate of clinical-stage programs at Imugene, which is developing immunotherapies across several modalities – including B-cell vaccines, oncolytic virotherapy, and off-the-shelf chimeric antigen receptor (CAR-T) therapies such as azer-cel, which targets the CD19 biomarker to treat blood cancers.

The company is focused on activating the immune system to treat cancer more effectively and durably than current standards of care, with multiple Phase I and II studies under way and strong backing from international research collaborators.