In another major step forward, Imugene Ltd (ASX:IMU, OTC:IUGNF) Ltd has started patient dosing in Australia for the Phase II Neo-POLEM clinical trial investigating its PD1-Vaxx immunotherapy in a specific subtype of colorectal cancer. The first patient was treated at Queen Elizabeth Hospital in Adelaide.
Neo-POLEM is a neoadjuvant study, meaning PD1-Vaxx is administered before surgery, aiming to enhance treatment outcomes in patients with mismatch repair-deficient / microsatellite instability-high (dMMR/MSI-high) colorectal cancer—a subtype affecting about 15% of colorectal cancer cases. The trial will recruit across Australia and the United Kingdom.
Imugene is a clinical-stage immuno-oncology company developing novel immunotherapies to harness the immune system to treat cancer. Its pipeline includes the B-cell vaccine PD1-Vaxx, the oncolytic virotherapy CF33, and an off-the-shelf CAR T therapy targeting CD19 for blood cancers. The company aims to provide foundational treatments for a range of solid and blood cancers, supported by global research collaborations and a well-capitalised platform.
Trial design and objectives
The Phase II Neo-POLEM trial is an Investigator Sponsored Trial (IST) led by Cancer Research UK’s Southampton Clinical Trials Unit in collaboration with the Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trials Group (AGITG). It is designed to assess PD1-Vaxx’s impact when administered prior to surgery.
The trial's primary endpoint is to determine the major pathological response rate—tumour size reduction following vaccination. Secondary endpoints include evaluating safety, identifying potential biomarkers, and measuring both objective response rates and overall survival.
“Dosing the first patient in the Neo-POLEM study represents hopeful treatment options for those suffering from these subtypes of colorectal cancer,” Imugene managing director and CEO Leslie Chong said. “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.”
Chong acknowledged the clinical teams and patients in both Australia and the UK whose participation is making the trial possible, reaffirming the company’s commitment to improving outcomes for people living with cancer.
Scientific rationale and broader significance
This study builds on early evidence indicating that immunotherapy may offer significant benefit to dMMR/MSI-high colorectal cancer patients. The PD1-Vaxx vaccine aims to stimulate the body’s immune system to identify and attack cancer cells at an early stage, potentially improving surgical outcomes and long-term prognosis.
Colorectal cancer is the third most common cancer globally, with over 1.2 million new cases each year and a 50% mortality rate. Approximately 80% of patients are diagnosed with resectable disease, underscoring the potential value of pre-surgical immunotherapy.