What the Research Shows
Personalized cancer vaccines are in active clinical development. Here is the published evidence, the ongoing trials, and the companies working to bring these treatments to patients.
Last updated: March 2026. All claims cite published sources.
Published Trial Results
Moderna + Merck: Intismeran Autogene (mRNA-4157/V940)
Personalized mRNA vaccine + pembrolizumab (Keytruda) for resected high-risk melanoma
Phase 2b (KEYNOTE-942)
49%
Reduced cancer recurrence at 5-year follow-up
HR=0.510; 95% CI 0.294-0.887; p=0.0075
62%
Reduced distant metastasis at 3-year follow-up
5-year distant metastasis data not yet released
Trial: NCT03897881 | 157 patients | Adjuvant melanoma (stage III/IV, post-resection)
Published: Lancet 2024;403:632-644
5-yr data: Journal of Clinical Oncology / PubMed, 2026
Phase 3 (INTerpath-001) — Ongoing
Trial: NCT05933577
Registry status checked July 2026; statuses and estimated dates can change.
No results have been published from this trial. The Phase 2b results above are from the earlier, smaller trial.
Mount Sinai: PGV001 (Personalized Genomic Vaccine)
Multi-peptide vaccine for patients across multiple cancer types
Phase 1 Results
13 of 14
Enrolled patients received vaccine
11
Patients completed treatment
Immune
Targeted T-cell and B-cell responses reported
Cancer types: NSCLC, head & neck, urothelial, breast, multiple myeloma
Published: PubMed / Cancer Discovery (2025)
Summary: Mount Sinai Scholars
This was a small Phase 1 study designed primarily to test safety, feasibility, and immunogenicity. The findings are useful early evidence that the platform can be feasible and immune-generating, but they are not proof of survival benefit or treatment efficacy. Larger controlled trials are needed to evaluate clinical benefit.
Companies Developing Personalized Vaccines
Over 250 companies and 300 drug candidates are in development globally. These are the most advanced programs with published clinical data.
| Company | Product | Type | Stage | Cancer(s) |
|---|---|---|---|---|
| Moderna + Merck | Intismeran autogene (mRNA-4157/V940) | mRNA | Phase 3 | Melanoma (adjuvant) |
| BioNTech | iNeST (individualized neoantigen therapy) | mRNA | Phase 2 | Multiple types |
| Nouscom | NOUS-PEV (personalized) + NOUS-209 (off-the-shelf) | Viral vector | Clinical | Frameshift neoantigen cancers |
| Evaxion | EVX-01 | Peptide (AI-designed) | Clinical | Metastatic melanoma |
| Transgene | TG4050 | Viral vector | Clinical | Ovarian, head & neck |
Sources: Cancer Vaccines Competitive Landscape Report 2026, company press releases, ClinicalTrials.gov
Academic Research Centers
Mount Sinai
Tisch Cancer Institute. PGV001 multi-peptide vaccine. Phase 1 study published in Cancer Discovery (2025), with early feasibility and immunogenicity data across mixed cancer types.
Mount Sinai ScholarsDana-Farber Cancer Institute
Center for Cancer Vaccines. Multiple neoantigen vaccine programs under development. Pioneering research in neoantigen identification and peptide vaccine design.
Dana-FarberNational Cancer Institute
Patient-friendly research coverage and federally supported cancer-vaccine research. NCI summaries are useful context but should still be read alongside the underlying paper or trial record.
NCI Cancer CurrentsHow to Read a Research Update
A registry update is not a result
ClinicalTrials.gov can change because of status, dates, enrollment estimates, locations, or administrative updates. Use the record to track a study, but do not treat a new timestamp as evidence that a product works.
A company release is not independent confirmation
Company announcements can identify important data, but the peer-reviewed paper and trial record should lead when available. Check the comparison group, cancer setting, phase, endpoint, and uncertainty before repeating a percentage.
One platform is not the whole field
Evidence for one mRNA or peptide product in one treatment setting does not establish the same benefit for another cancer, protocol, expanded-access product, or individual patient.
Open-Source Pipeline: OpenVaxx
OpenVaxx is an open-source technical project describing a computational and manufacturing workflow for a personalized mRNA cancer vaccine. It is useful for understanding concepts and research tooling; it is not a validated clinical protocol, medical service, or patient treatment pathway.
The OpenVaxx guide references open-source research tools such as GATK Mutect2 for mutation detection, pVACseq for neoantigen prediction, and MHCflurry for immune-binding prediction. Their availability is useful for understanding the computational workflow; it does not establish that a particular clinical program uses the same pipeline or that a research output is suitable for treatment.
Why this is not a treatment pathway
A public computational workflow can illustrate how researchers move from sequencing data to candidate neoantigens. It does not provide clinical eligibility review, a sponsor, an IND or trial protocol, institutional review, informed consent, GMP manufacturing, release testing, treating-physician oversight, administration, or safety monitoring.
Do not use OpenVaxx output to make or administer a vaccine. Its cost examples should not be compared directly with a clinical or expanded-access program as if the deliverables were equivalent.
Source: OpenVaxx on GitHub (Apache 2.0 license, created March 2026) | Interactive Guide
Medical Disclaimer: This page summarizes published clinical research and publicly available data. It does not constitute medical advice. Clinical trial results reflect specific patient populations and protocols; individual results will vary. Always consult your oncologist before making treatment decisions.
Last reviewed: March 2026. We update this page as new trial data is published.
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