# Personalised neoantigen (mRNA) vaccines

Source: https://onco.cc/technologies/neoantigen-mrna-vaccine/  
OnCo record `neoantigen-mrna-vaccine` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A vaccine made for one patient, encoding the unique mutations in their own tumour, to train the immune system to hunt it.

## Summary

Intismeran autogene (V940/mRNA-4157, Moderna/Merck) with pembrolizumab met RFS and DMFS endpoints in the phase 3 INTerpath-001 trial in resected stage IIB-IV melanoma (August 2026), the first positive phase 3 for an individualised neoantigen therapy. Autogene cevumeran (BioNTech/Genentech) showed durable T-cell responses correlating with recurrence-free survival in pancreatic cancer (phase 1, Balachandran) and is in phase 2. Phase 3 trials in NSCLC, RCC, bladder, and cutaneous squamous cell carcinoma are ongoing.

## Fields

- Kind: Technology
- Status: phase-3
- Last checked: 2026-09-04
- Principle: Tumour and normal DNA are sequenced, neoantigens are predicted computationally (up to 34 epitopes), and a patient-specific mRNA is made in lipid nanoparticles for dendritic cell presentation and T-cell priming, usually with PD-1 blockade.
- Since: 2017
- Strengths: Fully personalised, low toxicity; Adjuvant setting where tumour burden is low
- Limitations: 6-8 week manufacturing; Cost; Neoantigen prediction is imperfect; low-TMB tumours have few targets

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Cancer_vaccine
- Wikipedia: https://en.wikipedia.org/wiki/Cancer_vaccine

## Connected records

- ideas: [A frameshift neoantigen vaccine for Lynch syndrome carriers as the first preventive cancer vaccine approval](https://onco.cc/ideas/idea-moon-lynch-vaccine-phase3/), [A standing rulebook for one-patient treatments](https://onco.cc/ideas/idea-bio2-n-of-1-framework/), [Instruct tumour cells to make antibodies against their own oncoprotein](https://onco.cc/ideas/idea-bio1-mrna-intrabodies/), [mRNA-delivered MYC decoy proteins instead of MYC inhibitors](https://onco.cc/ideas/idea-bio1-omomyc-mrna/), [Personalised cancer vaccines at commodity cost through fully automated manufacturing](https://onco.cc/ideas/idea-moon-neoantigen-vaccines-at-scale/), [Personalised vaccines given only when the blood test turns positive](https://onco.cc/ideas/idea-bio2-mrd-triggered-neoantigen-vaccine/), [Shared modular GMP facilities for academic personalised vaccines and cell products](https://onco.cc/ideas/idea-fund-shared-personalised-therapy-gmp/), [Vaccinate against the resistance mutation before it takes over](https://onco.cc/ideas/idea-bio1-resistance-mutation-vaccine/), [Vaccines aimed only at mutations shared by every tumour cell](https://onco.cc/ideas/idea-bio1-clonal-neoantigen-vaccines/), [What makes a neoantigen actually immunogenic?](https://onco.cc/ideas/idea-neoantigen-immunogenicity-rules/)
- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/), [Melanoma](https://onco.cc/cancers/melanoma/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- drugs: [Autogene cevumeran](https://onco.cc/drugs/autogene-cevumeran/), [DCVax-L](https://onco.cc/drugs/dcvax-l/), [Intismeran autogene](https://onco.cc/drugs/intismeran-autogene/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [CeGaT](https://onco.cc/companies/cegat/), [CureVac](https://onco.cc/companies/curevac/), [Echo Immune](https://onco.cc/companies/echo-immune/), [Evaxion](https://onco.cc/companies/evaxion/), [Gamgee](https://onco.cc/companies/gamgee/), [Geneos Therapeutics](https://onco.cc/companies/geneos-therapeutics/), [Gritstone bio](https://onco.cc/companies/gritstone/), [Invoke Bio](https://onco.cc/companies/invoke-bio/), [Jaime Leandro Foundation](https://onco.cc/companies/jaime-leandro-foundation/), [Kernal Biologics](https://onco.cc/companies/kernal-biologics/), [Merck & Co. (MSD)](https://onco.cc/companies/merck/), [Moderna](https://onco.cc/companies/moderna/), [Nykode Therapeutics](https://onco.cc/companies/nykode-therapeutics/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/), [Serova](https://onco.cc/companies/serova/), [TareBio](https://onco.cc/companies/tarebio/), [Transgene](https://onco.cc/companies/transgene/), [UbiVac](https://onco.cc/companies/ubivac/)
- terms: [Cancer vaccines and oncolytic viruses](https://onco.cc/terms/vaccines-and-oncolytic-viruses/), [Hallmark: avoiding immune destruction](https://onco.cc/terms/avoiding-immune-destruction/), [Immune surveillance and cancer immunoediting](https://onco.cc/terms/immune-surveillance-immunoediting/), [Immunotherapy](https://onco.cc/terms/immunotherapy-term/), [Neoantigen](https://onco.cc/terms/neoantigen/), [RNA](https://onco.cc/terms/rna/)
- trials: [A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)](https://onco.cc/trials/nct06833073/), [A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)](https://onco.cc/trials/nct06961006/), [A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)](https://onco.cc/trials/nct06305767/), [A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I ](https://onco.cc/trials/nct07513376/), [A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).](https://onco.cc/trials/nct06307431/), [A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (](https://onco.cc/trials/nct06077760/), [A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)](https://onco.cc/trials/nct07221474/), [A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)](https://onco.cc/trials/nct06623422/), [A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC](https://onco.cc/trials/nct05968326/), [Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)](https://onco.cc/trials/autogene-cevumeran-phase-1/), [INTerpath-001 (V940-001)](https://onco.cc/trials/interpath-001/), [KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer](https://onco.cc/trials/nct07353645/), [Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC](https://onco.cc/trials/nct04912765/), [Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer](https://onco.cc/trials/nct07745790/)
- technologies: [Engineered exosomes as drug carriers](https://onco.cc/technologies/exosome-therapeutics/), [mRNA and lipid nanoparticle manufacturing](https://onco.cc/technologies/mrna-lnp-manufacturing/), [N-of-1 and rapid platform trials](https://onco.cc/technologies/n-of-1-platforms/), [Plasmid DNA and mRNA raw-material manufacturing](https://onco.cc/technologies/plasmid-dna-manufacturing/), [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/), [Self-amplifying and circular RNA therapeutics](https://onco.cc/technologies/self-amplifying-rna/), [Sterile fill-finish and lyophilisation](https://onco.cc/technologies/sterile-fill-finish/), [Whole-exome & whole-genome sequencing](https://onco.cc/technologies/wes-wgs/)
- key papers: [Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer](https://onco.cc/key-papers/paper-balachandran-neoantigen-quality-long-term-survivors-nature-2017/), [KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery](https://onco.cc/key-papers/paper-keynote-942-lancet-2024/), [RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer](https://onco.cc/key-papers/paper-sethna-rna-neoantigen-vaccine-long-lived-t-cells-nature-2025/), [Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer](https://onco.cc/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/)
- roadmaps: [Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity](https://onco.cc/roadmaps/immunotherapy-roadmap/), [Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question](https://onco.cc/roadmaps/pancreatic-roadmap/), [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/)
- institutions: [Abramson Cancer Center, University of Pennsylvania](https://onco.cc/institutions/penn-abramson/), [CeCurio (MVZ Tübingen oncology)](https://onco.cc/institutions/cecurio/), [Comprehensive Cancer Center Tübingen-Stuttgart](https://onco.cc/institutions/ccc-tuebingen/), [David H. Koch Institute for Integrative Cancer Research at MIT](https://onco.cc/institutions/mit-koch/), [Houston Methodist Center for RNA Therapeutics](https://onco.cc/institutions/houston-methodist-rna-therapeutics/), [IRCCS Regina Elena National Cancer Institute](https://onco.cc/institutions/regina-elena-rome/), [Lausanne University Hospital (CHUV) / Ludwig Institute Lausanne](https://onco.cc/institutions/chuv-lausanne/), [Siteman Cancer Center, Washington University](https://onco.cc/institutions/wustl-siteman/), [Society for Immunotherapy of Cancer](https://onco.cc/institutions/sitc/), [University Cancer Center Mainz (UCT Mainz) / Universitätsmedizin Mainz](https://onco.cc/institutions/uct-mainz/), [University of Florida Health Cancer Center](https://onco.cc/institutions/uf-health-cancer-center/)
- pathways: [Antigen presentation & immune editing](https://onco.cc/pathways/antigen-presentation-immunoediting/), [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/), [The cancer-immunity cycle](https://onco.cc/pathways/cancer-immunity-cycle/)
- pairings: [Personalised neoantigen vaccine + PD-1 blockade](https://onco.cc/pairings/vaccine-plus-pd1/)
- people: [Catherine J. Wu](https://onco.cc/people/catherine-wu/), [Drew Weissman](https://onco.cc/people/drew-weissman/), [Jeffrey S. Weber](https://onco.cc/people/jeffrey-weber/), [Kellie N. Smith](https://onco.cc/people/kellie-smith/), [Malachi Griffith](https://onco.cc/people/malachi-griffith/), [Nina Bhardwaj](https://onco.cc/people/nina-bhardwaj/), [Ton Schumacher](https://onco.cc/people/ton-schumacher/), [Uğur Şahin](https://onco.cc/people/ugur-sahin/), [Vinod P. Balachandran](https://onco.cc/people/vinod-balachandran/), [Yardena Samuels](https://onco.cc/people/yardena-samuels/), [Yuquan Wei](https://onco.cc/people/wei-yuquan/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)
- targets: [Claudin 6](https://onco.cc/targets/cldn6/)

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