science Clinical Evidence

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

M+M

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

Status Active, not recruiting
Patients enrolled ~1,089
Cancer type Resected melanoma (adjuvant)
Primary completion October 26, 2029 (est.)
Study completion September 26, 2030 (est.)
Designation Breakthrough Therapy

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.

Note on FDA status: Intismeran is investigational. The active-not-recruiting Phase 3 trial has not published efficacy results, and a registry completion estimate is not an approval forecast.
MS

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 Scholars

Dana-Farber Cancer Institute

Center for Cancer Vaccines. Multiple neoantigen vaccine programs under development. Pioneering research in neoantigen identification and peptide vaccine design.

Dana-Farber

National 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 Currents

How 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

info

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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