Imugene’s PD1-Vaxx colorectal cancer trial to feature at ESMO 2025 Congress

On October 20, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that an abstract for the Neo-POLEM Phase II trial has been accepted for e-poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held in Berlin, Germany, 17–21 October 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The accepted abstract, titled "Phase II trial of neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI-high colorectal cancer", will be presented by Dr Tony Dhillon, Consultant Medical Oncologist at the Royal Surrey NHS Foundation Trust, United Kingdom.

The ESMO (Free ESMO Whitepaper) Congress is Europe’s largest and most influential oncology meeting, attracting over 30,000 clinicians, researchers, patient advocates, and industry participants from around the world.

Imugene Managing Director and Chief Executive Officer Leslie Chong said: "We are delighted to see PD1-Vaxx recognised with presentation at the ESMO (Free ESMO Whitepaper) Congress, highlighting its growing international clinical footprint. The Neo-POLEM study marks an important expansion of our PD1-Vaxx program into early-stage colorectal cancer, an area where improved treatment options remain urgently needed."

Upon its release, the poster will be available on Imugene’s website at
View Source

About the Neo-POLEM study
Neo-POLEM is a collaborative investigator-initiated Phase II clinical trial coordinated by the Southampton Clinical Trials Unit (UK) in partnership with the Australasian Gastro- Intestinal Trials Group (AGITG) and funded by Imugene Limited.

The trial is designed to determine whether PD1-Vaxx, Imugene’s novel PD-1-targeting B- cell vaccine, can elicit major pathological responses in microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) early-stage colorectal cancer.

MSI-H colorectal tumours are characterised by high tumour mutation burden and immune infiltration, features that predict responsiveness to immunotherapy. PD10-Vaxx aims to induce a polyclonal B-cell antibody response against PD-1, potentially offering efficacy comparable to or greater than monoclonal antibody checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab) while improving safety and accessibility.

The single-arm Bayesian optimal design trial will enrol 44 patients with operable MSI-high or dMMR stage II–III colon cancer across 6–10 sites in the UK and Australia. Participants receive three PD1-Vaxx vaccinations over six weeks prior to surgical resection, followed by investigator-selected adjuvant therapy. The primary endpoint is major pathological response (MPR), defined as ≤ 10% viable tumour cells at resection. Secondary endpoints include safety, complete response rate, objective response rate, disease-free and overall survival, and surgical outcomes.

Recruitment commenced in May 2025, with the study now open at multiple Australian sites and UK site activation underway.

(Press release, Imugene, OCT 20, 2025, View Source [SID1234656780])