A new clinical trial led by Professor David Church, Cancer Research UK Senior Cancer Research Fellow at the Centre for Human Genetics, has been approved to begin in Oxford this summer. The trial will test an investigational mRNA-based vaccine designed to help prevent cancer in people with Lynch syndrome, an inherited condition that significantly increases the risk of several cancer types.
Phase 1 of the INTERCEPT-Lynch trial has received authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). The trial is funded by Moderna, sponsored by the University of Oxford, and run by the University’s Oncology Clinical Trials Office, with support from Oxford Cancer.
Lynch syndrome affects around one in 300 people worldwide and can cause a lifetime cancer risk of up to 80%. People with the condition have an increased risk of several cancers, including colorectal, endometrial, ovarian, stomach, pancreatic and prostate cancers.
The trial forms part of a scientific collaboration between the University of Oxford and Moderna to advance a novel mRNA approach to cancer prevention. It will test mRNA-4194, an investigational vaccine developed by Moderna, which is designed to train the immune system to recognise and eliminate pre-cancerous cells in people with Lynch syndrome before cancer develops.
Professor Church said:
“People with Lynch syndrome live with a very high risk of developing cancer, often at a younger age than the general population. The INTERCEPT-Lynch trial represents a meaningful step in our efforts to prevent Lynch syndrome-associated cancers before they develop.”
He added:
“By using mRNA vaccine technology to train the immune system to recognise early cancer changes, or what we call ‘pre-cancer,’ we hope to reduce cancer risk and ultimately improve the lives of people with this inherited condition.”
The first phase of the trial will assess the safety of the vaccine, characterise the immune response, and determine the optimal dose for further testing. The first participant is expected to receive the vaccine in Oxford this summer, with a second phase expected to begin in 2027 and expand recruitment to additional centres across the UK.
The trial is the culmination of three years of research into preventative treatments for Lynch syndrome-associated cancers in Oxford, involving a multidisciplinary team spanning the Nuffield Department of Medicine, the Department of Oncology, the MRC Weatherall Institute of Molecular Medicine and Oxford Cancer. Key contributors include Professor Ellie Barnes, Clinical Trial Lead for the immunological work, Professor Tim Elliott, Dr Eleni Adamopoulou and Dr Robert Watson, who leads the translational work underpinning the study and played a key role in establishing the trial alongside Professor Church.
Through Oxford Cancer, the trial was also designed in close collaboration with people with Lynch syndrome, helping to ensure that trial requirements are shaped by patient experience and do not place an excessive burden on participants.
The Lynch prevention research programme in Oxford was first funded through the Oxford Cancer Immuno-Oncology Network and later supported by Cancer Research UK, through a grant co-coordinated by the Oxford Centre for Cancer Early Detection and Prevention.
Read the full story on the Oxford Cancer website.