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Highlights
Imugene Ltd (ASX:IMU, OTC:IUGNF) initiates Australian enrolment for its Phase II Neo-POLEM study
The trial assesses PD1-Vaxx immunotherapy for a genetically distinct form of colorectal cancer
Conducted in partnership with leading cancer research institutions across Australia and the UK
Imugene Ltd (ASX:IMU), (OTC:IUGNF), a clinical-stage biotechnology company listed on the ASX 200, has commenced Australian enrolment for its Phase II Neo-POLEM trial investigating PD1-Vaxx. The study focuses on a specific subtype of colorectal cancer known for higher responsiveness to immunotherapy. The company operates in the healthcare and biotechnology space, a key component of benchmark indices due to its ongoing development of novel cancer therapies.
The Neo-POLEM trial, an investigator-sponsored initiative, aims to evaluate a neoadjuvant vaccine approach in patients with mismatch repair-deficient or microsatellite instability-high colorectal cancer. These patients typically show distinct biological characteristics, making them suitable candidates for immune-based treatment regimens.
PD1-Vaxx Focused on Immune Response Before Surgery
PD1-Vaxx, Imugene’s immunotherapy candidate, is a B-cell vaccine designed to stimulate the immune system to attack cancer cells by targeting PD-1. The current Phase II trial is being conducted with a neoadjuvant intent, meaning the therapy is administered prior to surgical intervention.
The study’s primary aim is to evaluate tumour response after treatment and before surgery. Investigators will monitor major pathological changes to determine how effectively the immune system responds. Secondary observations will include survival outcomes, immune biomarker activity, treatment safety, and overall response characteristics.
International Collaboration Strengthens Clinical Scope
The trial is led by Cancer Research UK Southampton Clinical Trials Unit and is supported by the Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trials Group (AGITG). This collaboration enhances the trial’s scientific and geographic reach, allowing patient recruitment across both the United Kingdom and Australia.
By working with prominent institutions, the study is positioned to generate substantial clinical insight into the role of immunotherapy in colorectal cancer treatment. Australian participation marks a key milestone in Imugene’s expansion of its immuno-oncology pipeline.
Colorectal Cancer Landscape and Trial Relevance
Colorectal cancer ranks among the most commonly diagnosed malignancies globally. A significant proportion of patients present with localised disease, which can be addressed surgically. However, recurrence and mortality remain major challenges in managing this cancer type.
Imugene’s PD1-Vaxx vaccine is directed at patients with dMMR/MSI-high colorectal cancer, a genetic subgroup recognised for being more susceptible to immune checkpoint intervention. The goal of the trial is to explore alternatives to conventional chemoradiation by leveraging immune activation strategies.
Imugene’s Broader Pipeline and Research Progress
The Neo-POLEM trial is part of Imugene’s broader clinical program, which spans multiple immunotherapeutic platforms. The company is also developing B-cell vaccines, oncolytic virotherapies, and chimeric antigen receptor T-cell technologies such as azer-cel, designed to address blood cancers through targeted immune responses.
Imugene Ltd (ASX:IMU), (OTC:IUGNF) continues to collaborate with international research bodies in advancing treatments that focus on activating and sustaining immune-based cancer control. The expansion of the Neo-POLEM trial to Australian patients underscores ongoing momentum in its clinical development efforts.
