Imugene Ltd (ASX:IMU, OTC:IUGNF) is preparing 10 clinical trial sites in Australia and the UK for a new PD1-Vaxx Phase 2 colorectal (CRC) cancer clinical trial set to begin in 2024.
The company intends to enrol 44 patients across the six Australian and four UK sites, to participate in the study for about 18 months.
The primary objective of the trial is to determine major pathological response rates, a measurement of tumour size, after treating with PD1-Vaxx but before surgery to remove any residual tumour – also known as neoadjuvant in operable CRC cancer patients.
“Potentially groundbreaking trial”
This trial will be conducted by the Cancer Research UK Southampton Clinical Trials Unit at the University of Southampton in collaboration with Royal Surrey Hospital NHS Foundation Trust and The Australasian Gastro-Intestinal Trials Group (AGITG).
“We are very excited to open this potentially groundbreaking trial using a vaccine to PD-1 in MSI High early colorectal cancer,” chief investigator Dr Tony Dhillon of the Royal Surrey Hospital NHS Foundation Trust said.
“Prof Tim Price (co-chief investigator), 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.”
Third most common cancer
CRC or bowel cancer is the third most common cancer with a mortality rate of about 50%.
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).
“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,” Imugene managing director and CEO Leslie Chong said.
“The study costs are partially funded being Investigator Sponsored studies, and fall within current cash flow forecasts.”