Personalised neoantigen (mRNA) vaccines
A vaccine made for one patient, encoding the unique mutations in their own tumour, to train the immune system to hunt it.
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.
How it works
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.
- Fully personalised, low toxicity
- Adjuvant setting where tumour burden is low
- 6-8 week manufacturing
- Cost
- Neoantigen prediction is imperfect; low-TMB tumours have few targets
BioNTech's personalised vaccine, notable for a small pancreatic cancer study where vaccine responders stayed cancer-free for years.
A personalised vaccine made from the patient's own immune cells and tumour. Its 20-year-old phase 3 trial reported longer survival, but the way the result was analysed has divided the field.
A custom mRNA vaccine encoding up to 34 of a patient's own tumour mutations. In August 2026 it became the first personalised cancer vaccine to win a phase 3 trial.
For the first time a randomised trial suggests that a vaccine tailored to an individual's tumour can reduce relapse when combined with immunotherapy, which is a proof of concept for a field that had failed for decades. Nothing changes for patients yet: the trial was small, the confidence interval crossed one, and the phase 3 trial in melanoma (and parallel trials in lung and other cancers) must confirm it. If it does, personalised mRNA vaccines could become a routine adjunct to checkpoint inhibitors after surgery.
Pancreatic cancer was thought to be immunologically inert because of its low mutation burden; this study showed that with the right vaccine platform its few neoantigens can still be targeted. It is the strongest human evidence so far that personalised cancer vaccines can generate durable, tumour-specific immunity, and it justifies the randomised trials now running in pancreatic cancer and melanoma. Benefit is not yet proven, because responders may simply have had more immunogenic tumours.
Latest papers
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Pages like this
not linked directly; found by shared links- TechnologyOff-the-shelf cancer vaccines
Shares Gritstone bio, Yuquan Wei, DCVax-L, Nina Bhardwaj.
- TechnologyIn vivo CAR-T
Shares Drew Weissman, Self-amplifying and circular RNA therapeutics, Engineered exosomes as drug carriers, Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity.
- TechnologyTIL therapy
Shares Shared modular GMP facilities for academic personalised vaccines and cell products, Vaccines aimed only at mutations shared by every tumour cell, Immunotherapy, Lausanne University Hospital (CHUV) / Ludwig Institute Lausanne.
- TermHot vs cold tumours
Shares Immunotherapy, Hallmark: avoiding immune destruction, Society for Immunotherapy of Cancer, The cancer-immunity cycle.
- CompanyOrna Therapeutics (Eli Lilly)
Shares Instruct tumour cells to make antibodies against their own oncoprotein, mRNA-delivered MYC decoy proteins instead of MYC inhibitors, Self-amplifying and circular RNA therapeutics.
- TechnologyTCR-T cell therapy
Shares What makes a neoantigen actually immunogenic?, Ton Schumacher, Comprehensive Cancer Center Tübingen-Stuttgart, Lausanne University Hospital (CHUV) / Ludwig Institute Lausanne.
- TechnologyOligonucleotide therapeutics
Shares RNA, A standing rulebook for one-patient treatments, Engineered exosomes as drug carriers.
- BottleneckNo one can predict who responds to immunotherapy
Shares Vaccinate against the resistance mutation before it takes over, Vaccines aimed only at mutations shared by every tumour cell, Personalised cancer vaccines at commodity cost through fully automated manufacturing, KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery.