NatureFeb 18, 2026

Personalized mRNA vaccines may produce lasting T cell immune response in early-stage triple-negative breast cancer

mRNA Technology Weekly Brief ↗PubMed ↗DOI ↗OA ↗

Updated Jun 28, 2026

Abstract

Essence

An individualized neoantigen mRNA vaccine was feasible in adjuvant TNBC and generated durable functional T cell responses to multiple neoantigens.

Evidence

This small clinical cohort followed 14 patients with TNBC after surgery and neoadjuvant or adjuvant therapy, finding mostly de novo vaccine-induced T cell responses in peripheral blood that remained functional for years, while 11 patients stayed relapse-free for up to 6 years.

Caveat

The study was uncontrolled and very small, so relapse outcomes cannot be attributed to the vaccine alone, especially with observed immune escape and one genetically distinct recurrence.

Simplified

Triple-negative breast cancer (TNBC) is frequently associated with metastatic relapse, even at an early stage. Here we assessed an individualized neoantigen mRNA vaccine in 14 patients with TNBC following surgery and after neoadjuvant or adjuvant therapy. In peripheral blood of nearly all patients, high-magnitude, vaccine-induced, mostly de novo T cell responses to multiple neoantigens were detected that remained functional for several years. Characterization of individual patients revealed that a large proportion of these T cells developed into two subsets: a late-differentiated phenotype with markers indicative of 'ready-to-act' cytotoxic effector T cells, and T cells with a stem cell-like memory phenotype. Eleven patients remained relapse-free for up to six years post-vaccination. Recurrence occurred in three patients: the individual with the weakest vaccine-induced T cell response relapsed, but achieved complete remission on subsequent anti-PD-1 therapy; another patient had a tumour with low major histocompatibility complex (MHC) class I expression with MHC class I-deficient cells growing out under vaccination; and the third patient was BRCA-positive and had a recurrence from a genetically distinct primary tumour. These findings demonstrate the feasibility of individualized RNA vaccines in TNBC, document persistence of vaccine-induced, functional neoantigen-specific T cells and provide insights into possible immune escape mechanisms that will guide future approaches. 1

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Funding

Competing interests

Competing interests: U.S. and Ö.T. are management board members and employees at BioNTech SE. E.D., A.C., I.V., T.O., E.G., S.N., J.G., N.B., S. Bolte, S. Brachtendorf, J.S., T.S., D.L., D.B., J.B. and A.F. are employees at BioNTech SE. U.S. and Ö.T. are inventors on patents and patent applications related to RNA technology. U.S., E.D., A.C., I.V., T.O., E.G., S.N., J.G., N.B., S. Bolte, S. Brachtendorf, J.S., T.S., D.L., D.B., J.B., A.F. and Ö.T. have equity interests in BioNTech SE. M.S. reports personal fees from AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Exact Sciences, Gilead, Lilly, Menarini-Stemline, Molecular Health, MSD, Novartis, Pantarhei Bioscience, Pfizer, Pierre Fabre, Roche and SeaGen, His institution has received research funding from AstraZeneca, BioNTech, Eisai, Genentech, German Breast Group, Novartis, Palleos, Pantarhei Bioscience, Pierre Fabre and SeaGen. In addition, M.S. is an inventor on patents EP 2390370 B1 and EP 2951317 B1.

PubMed

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Personalized mRNA vaccines may produce lasting T cell immune response in early-stage triple-negative breast cancer

Abstract

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Funding

Competing interests

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