The Fort Worth Press - 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

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 anticipate the first patient to be dosed this summer. The second phase will expand enrollment across multiple centers 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 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 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 centers, 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.

About precision prevention research at the University of Oxford

Precision prevention research focuses on groups of people at higher risk of developing cancer and matches them to biologically-targeted agents that aim to stop cancer from developing. The approach aims to delay or prevent cancer, improving outcomes while reducing the burden of complex treatments on individuals and healthcare systems. INTERCEPT-Lynchforms part of Oxford's expanding cancer precision prevention research programme.

About the University of Oxford

Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the ninth year running, and number 3 in the QS World Rankings 2024. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer.

Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions.

Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 300 new companies since 1988. Over a third of these companies have been created in the past five years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential of mRNA to target pre-cancerous cells before cancer develops; expectations regarding timing of the Phase 1 study, including commencement of the second phase in 2027; and Moderna's ongoing strategic partnership with the UK Government. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

University of Oxford Contacts

For interviews with Professor David Church, lead of the INTERCEPT-Lynch study, please contact the University of Oxford News Office: [email protected].

Moderna Contacts

Media:

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

[1] 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/
[2] Mayo Clinic. (2025, December 2). Lynch syndrome: Symptoms and causes. https://www.mayoclinic.org/diseases-conditions/lynch-syndrome/symptoms-causes/syc-20374714
[3] 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
[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

SOURCE: Moderna, Inc.

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L.Davila--TFWP