The UK Medicines and Healthcare products Regulatory Agency has authorized the Phase 1/2 INTERCEPT-Lynch trial, the first clinical study of Moderna and the University of Oxford's mRNA-4194 vaccine. Designed to prevent cancers in people with Lynch syndrome—a genetic condition affecting 1 in 300 people that carries an 80% lifetime cancer risk—the vaccine trains the immune system to eliminate pre-cancerous cells. Dosing begins in summer 2026, marking a major shift from treating cancer to preventing it.
INTERCEPT-Lynch trial regulatory approval
- ▪The second phase of the INTERCEPT-Lynch trial is expected to begin in 2027 and will expand recruitment to additional centers across the United Kingdom.
- ▪The Phase 1/2 trial of mRNA-4194, known as the INTERCEPT-Lynch trial, is funded by Moderna, sponsored by the University of Oxford, and scheduled to begin dosing participants in summer 2026.
- ▪The UK Medicines and Healthcare products Regulatory Agency authorized a Phase 1/2 clinical study of Moderna's investigational cancer prevention vaccine, mRNA-4194.
Lynch syndrome hereditary cancer
- ▪Lynch syndrome is an inherited genetic condition affecting approximately 1 in 300 people worldwide that carries a lifetime cancer risk of up to 80%.
- ▪Lynch syndrome significantly elevates the risk of developing several cancer types, including colorectal, endometrial, ovarian, stomach, pancreatic, and prostate cancers.
- ▪Lynch syndrome is caused by inherited mutations in DNA mismatch repair genes, including MLH1, MSH2, MSH6, PMS2, and EPCAM, which allow DNA errors to accumulate.
mRNA-4194 vaccine mechanism
- ▪The investigational vaccine mRNA-4194 is designed to leverage mRNA technology to train the immune system to recognize and eliminate pre-cancerous cells before cancer develops.
- ▪The Phase 1/2 study will administer mRNA-4194 to participants with Lynch syndrome to assess safety, characterize immune response, and determine the optimal dose.
Moderna-Oxford UK partnership
- ▪The strategic partnership between Moderna and the United Kingdom government has delivered more than 20 clinical trials across 135 centers involving over 14,500 participants.
- ▪The INTERCEPT-Lynch trial is part of a 10-year strategic partnership established in 2022 between Moderna and the United Kingdom government to strengthen mRNA capabilities.
Precision prevention research
- ▪Precision prevention research focuses on matching high-risk patient groups with biologically-targeted agents to delay or stop cancer from developing.
- ▪Current care options for individuals with Lynch syndrome are limited to regular surveillance, low-dose aspirin, and preventive surgery in select cases.
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