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Phase 1 of the INTERCEPT-Lynch trial, which 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, has received authorisation from the Medicines and Healthcare products Regulatory Agency and is expected to begin recruiting participants this summer.

Doctor using a laptop

The trial forms part of a scientific collaboration between the University of Oxford and Moderna to advance a novel mRNA approach to cancer prevention. Led by Professor David Church, Cancer Research UK Senior Cancer Research Fellow in the University of Oxford’s Centre for Human Genetics in the Nuffield Department of Medicine, it will test ‘mRNA-4194’, an investigational mRNA-based vaccine developed by Moderna, which is designed to help prevent cancer in people with Lynch syndrome (LS).

LS is an inherited condition that affects around one in 300 people worldwide, which causes lifetime cancer risk of up to 80%. People with the condition face elevated risks of several cancer types, including colorectal, endometrial, ovarian, stomach, pancreatic and prostate cancers.

mRNA-4194 is designed to leverage mRNA technology to train the immune system to recognise and eliminate pre-cancerous cells in LS before cancer develops. The trial will administer the vaccine to participants with LS to assess safety, characterise immune response and determine the optimal dose for further testing. It is anticipated that the first participant will receive the vaccine in Oxford this summer. A second phase of the trial, expected to begin in 2027, will expand recruitment to additional centres across the UK.

“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,” said Professor David Church. “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.” 

Read the full story on the Oxford Cancer website.