A new signal-seeking study, investigating a novel treatment vaccine for patients with colorectal cancer, is now open in Australia.
Neo-POLEM is an internationally led study led by Dr Tony Dhillon (Royal Surrey, UK) and the Cancer Research UK Southampton Clinical Trials Unit at the University of Southampton, and supported by clinical-stage immuno-oncology company, Imugene Limited.
Led locally by Professor Tim Price, Neo-POLEM is exploring the efficacy of PD1-Vaxx which has shown a preliminary promising response in lung cancer. The hope is that we will see a similar response in patients with early colorectal cancer where the tumour has defective mismatch repair.
We’re proud to be collaborating with the Cancer Research UK Southampton Clinical Trials Unit and Imugene Limited to make this potentially ground-breaking clinical trial available to Australian patients, speeding up access to an innovative treatment option.
“To lead this trial in Australia is exciting. The results have the potential to make changes to international protocols,” says Professor Price.
Professor Gareth Griffiths, Director of Southampton Clinical Trials Unit says “We are looking forward to this amazing opportunity to work closely with our Australian research partners to investigate whether this cancer vaccine is of benefit to our UK and Australian colorectal patients. If we see evidence of activity and safety this would justify a future larger randomised trial which could change practice”.
About PD1-Vaxx
Around one in seven diagnoses of colorectal cancer have defective mismatch repair (dMMR). This is associated with a high rate of tumour mutation where abnormal cells cannot be repaired. Promisingly, recent small trials have shown this subtype to be sensitive to immunotherapy.
PD1-Vaxx is a B-cell immunotherapy being developed by clinical stage immuno-oncology company Imugene Limited, and aims to generate antibodies against the protein programmed death-1 (PD-1), stimulating the immune system to attack cancer cells. Studies have shown both the safety of this method and its efficacy in inhibiting small cell lung cancers. With the treatment being neoadjuvant we hope to see a clear signal of the vaccine’s impact.
“We already know that intravenous antibodies can shrink colorectal cancers before they are removed, but Neo-POLEM will allow a simpler vaccine method of delivery and could preclude the need for chemotherapy after surgery,” explains Professor Price.
More about Neo-POLEM
Neo-POLEM is a single arm study. PD1-Vaxx is associated with minimal side effects, and with three vaccines delivered over six weeks, the timeframe is similar to the usual surgery waiting time, avoiding treatment delays.
Neo-POLEM has a recruitment target of 44 participants over 18-months: 20 in Australia and 24 in the United Kingdom. Locally, it will be conducted across four to six sites, utilising teletrial capability and spanning metropolitan and regional centers, offering equitable access for patients across Australia.
The first site to participate in the study is The Queen Elizabeth Hospital in South Australia.
Neo-POLEM is an international study conducted by Cancer Research UK Southampton Clinical Trials Unit in collaboration with Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trials Group (AGITG). The University of Southampton is the academic Sponsor of Neo-POLEM with AGITG is acting as the local sponsor, with the AGITG Clinical Research Centre as the coordinating centre and Professor Tim Price as the local study lead. Neo-POLEM is funded by clinical-stage immuno-oncology company, Imugene Limited.