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Moderna and the University of Oxford Receive UK Authorization to Begin Phase 1/2 Study of Investigational mRNA Cancer Vaccine for People with Lynch Syndrome
Moderna and the University of Oxford Receive UK Authorization to Begin Phase 1/2 Study of Investigational mRNA Cancer Vaccine for People with Lynch Syndrome
About this update from Moderna, Inc.
Lynch syndrome is an inherited condition affecting 1 in 300 people that causes lifetime cancer risk of up to 80%[1]The INTERCEPT-Lynch trial is part of a scientific collaboration between the University of Oxford and Moderna to advance a novel mRNA approach to cancer prevention OXFORD, UK AND CAMBRIDGE, MA / ACCESS Newswire / June 8, 2026 / 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) authorization 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[2]. It is the most common hereditary cancer predisposition condition, affecting 1 in 300 people[3], and increases the risk of several cancer types, including colorectal, endometrial, ovarian, stomach, and prostate cancers[4]. Today, care options for people with Lynch syndrome remain limited to regular surveillance, with low-dose aspirin and 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 program."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."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 Center, will administer mRNA-4194 to participants with Lynch syndrome to assess safety, characterize immune response and determine the optimal dose for further testing. Moderna and the University of Oxford anti...