Moderna receives UK authorization to begin Phase 1/2 study of investigational mRNA cancer vaccine for people with Lynch syndrome

The University of Oxford and Moderna, Inc. have announced that a Phase 1/2 study of mRNA-4194, Moderna’s investigational mRNA-based cancer vaccine for Lynch syndrome, has secured authorization from the Medicines and Healthcare products Regulatory Agency in the UK.

Lynch syndrome is a hereditary condition that raises a person’s risk of developing cancer, arising from alterations in genes responsible for repairing DNA, which in turn allows cells to accumulate errors that can eventually lead to cancer. As the most prevalent hereditary cancer predisposition condition, affecting one in every 300 people, it heightens the risk of several cancer types including colorectal, endometrial, ovarian, stomach, and prostate cancers. At present, care for those with Lynch syndrome is largely confined to regular surveillance, with low-dose aspirin and surgery reserved for select cases.

mRNA-4194 has been designed to provoke immune responses against specific targets linked to the earliest stages of cancer development in people with Lynch syndrome, marking Moderna’s first foray into cancer prevention as opposed to treatment.

“This MHRA authorization marks an important milestone as we explore approaches to shift cancer care from treating disease to preventing it. By applying mRNA technology earlier in the patient journey, we aim to harness the immune system when it can have the greatest impact,” said David Berman, M.D., Ph.D., Chief Development Officer, Moderna. “We are proud to bring this innovation to the UK, building on our long-standing collaboration with leading UK institutions to advance mRNA research and development. We are deeply grateful to the participants, investigators and partners who make this research possible.”

Funded by Moderna and sponsored by the University of Oxford, the Phase 1/2 study will be carried out through the University’s Oncology Clinical Trials Office and the Oxford Cancer Center. It will involve administering mRNA-4194 to participants with Lynch syndrome to evaluate safety, characterise the resulting immune response, and identify the most suitable dose to carry forward into further testing. The first participant is expected to receive a dose this summer, with a second phase set to widen enrollment across several UK centres, Oxford among them, beginning in 2027.

“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, Cancer Research UK Senior Cancer Research Fellow in the University of Oxford’s Centre for Human Genetics in the Nuffield Department of Medicine, and lead investigator on the trial. “By using mRNA vaccine technology to train the immune system to recognize 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.”

This trial forms part of a ten year strategic partnership struck between Moderna and the UK Government back in 2022, designed to bolster the UK’s mRNA capabilities and strengthen pandemic preparedness. Alongside the partnership’s broader achievements, among them the Moderna Innovation and Technology Centre in Harwell, Oxfordshire, which opened its doors in September 2025, the collaboration has driven substantial investment in UK-based research and development, delivering more than 20 clinical trials across 135 centres and involving upwards of 14,500 participants to date. The Moderna Strategic Partnership is overseen by the UK Health Security Agency on behalf of the Department of Health and Social Care.

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Related Topics and Keywords

Lynch syndrome, Moderna, mrna cancer vaccine, Phase 1/2 study