Imugene Ltd 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 is now recruiting patients in both Australia and the United Kingdom to assess the neoadjuvant B-cell vaccine designed to trigger an immune response against PD-1.
Targeting Specific Cancer Subtype
The trial focuses on patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer, a genetic subtype that accounts for about 15% of colorectal cancer cases. This subtype is considered more responsive to immunotherapy compared to other forms of the disease.
"This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population," the company stated.
Trial Design and Objectives
The Neo-POLEM study will evaluate how PD1-Vaxx performs when administered before surgery, with the primary aim of determining major pathological response – a measure of tumor 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 study is being conducted in partnership with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trials Group (AGITG).
Clinical Significance and Market Impact
Colorectal cancer represents the third most common cancer worldwide, with more than 1.2 million new cases diagnosed annually. Despite approximately 80% of patients presenting with localized and resectable disease, the global mortality rate remains around 50%.
Imugene CEO and managing director Leslie Chong welcomed the trial progress, stating: "We're very pleased to see this Neo-POLEM IST open and enrolling in Australia. 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."
Broader Pipeline Development
The company 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 Imugene's growing slate of clinical-stage programs, which includes 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.
Imugene 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.
