The University of Oxford and Moderna, Inc. (NASDAQ: MRNA) today announced a Phase 1/2 study of mRNA-4194, Moderna’s investigational mRNA-based cancer vaccine for Lynch syndrome, has received Medicines and Healthcare products Regulatory Agency (MHRA) authorisation in the UK.
Lynch syndrome is an inherited condition that increases cancer risk. It is caused by alterations in genes responsible for repairing DNA, leading cells to accumulate DNA errors which can lead to cancer[3]. It is the most common hereditary cancer predisposition condition, affecting one in 300 people worldwide1, and increases the risk of several cancer types, including colorectal, endometrial, ovarian, stomach, pancreatic and prostate cancers[4]. Today, care options for people with Lynch syndrome remain limited to regular surveillance, with low-dose aspirin and preventative surgery used in select cases[5].
mRNA-4194 is designed to generate immune responses against selected targets associated with early cancer development in people with Lynch syndrome. mRNA-4194 represents Moderna’s first investigational cancer prevention programme.
“This MHRA authorisation 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 (pictured), 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.”
The Phase 1/2 study, funded by Moderna, sponsored by the University of Oxford, and run by the University’s Oncology Clinical Trials Office and Oxford Cancer centre, will administer mRNA-4194 to participants with Lynch syndrome to assess safety, characterise immune response and determine the optimal dose for further testing. Moderna and the University of Oxford anticipate the first patient to be dosed this summer. The second phase will expand enrolment across multiple centres in the UK, including Oxford, and is expected to begin 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 the lead investigator in the trial. “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.”
This clinical trial is part of a 10-year strategic partnership between Moderna and the UK government, established in 2022, to strengthen the UK’s mRNA capabilities and pandemic preparedness. In addition to the construction of the Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire, which opened in September 2025, the collaboration includes significant investment in UK-based R&D, with more than 20 clinical trials delivered across 135 centres, involving more than 14,500 participants to date. The Moderna Strategic Partnership (MSP) is managed by the UK Health Security Agency (UKHSA) on behalf of the Department of Health and Social Care.
References
SOURCE: Moderna, Inc.
[1] Underkofler, K. A., & Ring, K. L. (2023). Updates in gynecologic care for individuals with Lynch syndrome. Frontiers in Oncology, 13, 1127683. https://doi.org/10.3389/fonc.2023.1127683
2 Sherman, S., Ojha, S. K., Menon, G., et al. (2025, January 19). Hereditary nonpolyposis colon cancer (Lynch syndrome). In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK564511/
3 Mayo Clinic. (2025, December 2). Lynch syndrome: Symptoms and causes. https://www.mayoclinic.org/diseases-conditions/lynch-syndrome/symptoms-causes/syc-20374714
4 American Cancer Society. (2024, May 13). Lynch syndrome. https://www.cancer.org/cancer/risk-prevention/genetics/family-cancer-syndromes/lynch-syndrome.html
5 MD Anderson. (2024, April 24). Lynch syndrome: 10 things to know about this genetic condition. https://www.mdanderson.org/cancerwise/qa-understanding-and-managing-lynch-syndrome.h00-158589789.html
