On December 6, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported that it has signed a letter of intent with the University of Southampton in collaboration with Cancer Research UK Southampton Clinical Trials Unit at the Royal Surrey Hospital NHS Foundation Trust and The Australasian Gastro-Intestinal Trials Group (AGITG) to open a Phase 2 clinical trial, "Neo-POLEM", in which PD1-Vaxx vaccine will be evaluated for patients diagnosed with operable CRC cancer (Press release, Imugene, DEC 6, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/c775a9b4-092f-5f07-cd7b-52899fee7961/New_PD1_Vaxx_Phase_2_CRC_Cancer_Trial_to_Open_in_UK_and_AUS.pdf [SID1234638199]).
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The Chief Investigator is Dr Tony Dhillon based at the Royal Surrey Hospital NHS Foundation Trust in Surrey in collaboration with the University of Southampton, UK and Co-Chief Investigator Prof Timothy Price from the Queen Elizabeth Hospital in Adelaide, SA.
Dr Tony Dhillon said, "We are very excited to open this potentially groundbreaking trial using a vaccine to PD-1 in MSI High early colorectal cancer. Prof Tim Price, Imugene and I have been working on the trial design and are thrilled to finally see sites set up in the UK and Australia. We are grateful to the University of Southampton Clinical trials Unit (CTU) who are running the trial and the Australasian Gastro-Intestinal Trials Group (AGTIG) who have been involved from the beginning".
The title of the study is "A phase 2 trial of neoadjuvant PD-1 vaccine IMU-201 (PD1-Vaxx) in operable dMMR/MSI-H Colorectal Cancer" (see below for further explanation and definition). The primary objective of the study is to determine the pathological response rates and the secondary objectives are to assess the safety of PD1-Vaxx, evaluate biomarkers, and evaluate the objective response rates and overall survival.
Imugene MD & CEO, Ms Leslie Chong said, "We are excited to commence this important Phase 2 trial with PD1-Vaxx after being approached by the leading colorectal cancer oncologists from both Australia and the UK. The study costs are partially funded being Investigator Sponsored studies, and fall within current cash flow forecasts, she added."
Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer, with a worldwide annual incidence of over 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. In 2018, there were 15,610 new cases of bowel cancer diagnosed in Australia (8,490 males and 7,120 females). In 2022, an estimated 15,713 new cases of bowel cancer were diagnosed in Australia (8,300 males and 7,413 females). It is estimated that a person has a 1 in 19 (or 5.2%) risk of being diagnosed with bowel cancer by the age of 85 (1 in 18 or 5.6% for males and 1 in 21 or 4.8% for females)1.
Neoadjuvant (before surgery) chemotherapy and surgical resection of the colon or rectum is the standard of care treatment for locally advanced colorectal cancer. A subset of colorectal cancer is caused by a deficiency in "mismatch repair" (dMMR), a phenomenon known as microsatellite instability (MSI), which results in a higher mutation of the cancer cells and more rapid tumour growth. Because mismatch repair–deficient colorectal cancer is responsive to programmed death 1 (PD-1) blockade in the context of metastatic disease, it is hypothesized that checkpoint blockade with PD1-Vaxx could be effective in patients with mismatch repair–deficient, locally advanced colorectal cancer.