Ann: 1st Australian site activated PD1-Vaxx Neo-POLEM Ph II trial, page-3

ASX Announcement
First site activation in Australia for PD1-Vaxx Neo-POLEM Phase II trial
• The Phase II 'Neo-POLEM' Investigator Sponsored Trial (IST) will investigate the
potential of PD1-Vaxx to improve treatment outcomes in a specific kind of
colorectal cancer (bowel cancer)
• The trial will recruit patients in both Australia and the United Kingdom.
• Colorectal cancer is the world's third most common cancer, with 80% of cases
treatable at diagnosis.

SYDNEY, Australia, 2 June 2025: Imugene Limited (ASX: IMU), a clinical-stage immuno
oncology company, is pleased to announce the first site activation within Australia, as
part of the investigator sponsored Phase II Neo-POLEM clinical trial.

Neo-POLEM is a Phase II study investigating the potential of PD1-Vaxx, a neoadjuvant PD
1 vaccine, to improve treatment outcomes for patients with mismatch repair-deficient /
microsatellite instability high (dMMR/MSI-high) colorectal cancer. Approximately 15% of
patients with colorectal cancer have the dMMR/MSI-high subtype.
The trial is an IST being conducted by Cancer Research UK Southampton Clinical Trials
Unit in collaboration with Royal Surrey Hospital NHS Foundation Trust and the Australasian
Gastro-Intestinal Trial Group (AGITG).
The primary objective of the study is to determine major pathological response rates, a
measure of tumour size reduction post-treatment with PD1-Vaxx before surgery, with
secondary objectives to assess the safety of PD1-Vaxx, evaluate biomarkers, and
evaluate the objective response rates and overall survival.
This trial builds upon compelling early evidence that immunotherapy can deliver
significant benefits in this patient population. The trial will recruit patients in both Australia
and the United Kingdom.
Imugene’s CEO and Managing Director Leslie Chong said: “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.”
Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer,
with a worldwide annual incidence of more than 1.2 million cases and a mortality rate of
approximately 50%. About 80% of patients with colon cancer have localised and
resectable disease at diagnosis. Approximately 15% of CRC is dMMR/MSI-high.
For more information please contact:
Leslie Chong
Managing Director and Chief Executive Officer
[email protected]
General Investor Enquiries
[email protected]
Media Enquiries
Matt Wright
[email protected]