On June 27, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first patient dosed in Australia, as part of the investigator sponsored Phase II Neo-POLEM clinical trial (Press release, Imugene, JUN 27, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/4621b5ea-5e19-3f10-0982-51c3e3f18e9e/1st_Patient_Dosed_in_Australia_PD1_Vaxx_neo_POLEM_PhII_Trial.pdf [SID1234654143]).
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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: "Dosing the first patient in the Neo-POLEM study represents hopeful treatment options for those suffering from these subtypes of colorectal cancer. We are encouraged by the potential of PD1-Vaxx to activate the body’s own immune system to fight cancer in this earliest stage of disease. Our focus remains firmly on improving outcomes for people living with this disease, and we’re grateful to the patients and clinical teams in Australia and the UK who are making this progress possible."
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.