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: Merck press release, Jan 20, 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

Last updated on ClinicalTrials.gov: September 22, 2025

No results have been published from this trial. The Phase 2b results above are from the earlier, smaller trial.

Note on FDA status: The FDA denied a request for accelerated approval based on Phase 2b data in September 2024. Moderna and Merck are pursuing conventional approval through the Phase 3 trial. An FDA approval filing is possible after Phase 3 results are available, potentially in 2030 or later.
MS

Mount Sinai: PGV001 (Personalized Genomic Vaccine)

Multi-peptide vaccine for patients across multiple cancer types

Phase 1 Results

6 of 13

Patients alive at 5-year follow-up

3

Patients completely tumor-free at 5 years

Cancer types: NSCLC, head & neck, urothelial, breast, multiple myeloma

Published: Cancer Discovery, Vol 15, Issue 5 (2025)

Press: Mount Sinai Newsroom, Mar 2025

This was a small Phase 1 trial designed primarily to test safety. The survival results are encouraging but should be interpreted with caution given the small sample size (13 patients) and lack of a control group. Larger trials are needed to confirm efficacy.

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 complete with 5-year follow-up data published in Cancer Discovery (2025). 5 cancer types treated.

Mount Sinai Newsroom

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

UNSW RNA Institute

Manufactured the custom mRNA vaccine for the Paul Conyngham case (dog cancer treatment using AI-designed targets). Led by Professor Pall Thordarson.

UNSW RNA Institute

The Story That Went Viral

In March 2026, a story about a Sydney tech entrepreneur's dog brought personalized cancer vaccines into mainstream awareness.

Paul Conyngham & Rosie

Paul Conyngham, founder of Core Intelligence Technologies, used ChatGPT, Grok, and Google's AlphaFold to research and design a personalized mRNA vaccine for his dog Rosie, who had been diagnosed with mast cell cancer after surgery and chemotherapy failed. UNSW's RNA Institute manufactured the custom vaccine. Rosie received the vaccine alongside checkpoint inhibitors.

Conyngham reported on Australia's Today Show (March 15, 2026) that the primary tumor shrank approximately 75% over three months following the first injection in December 2025.

Professor Pall Thordarson of UNSW cautioned: "This may not have cured Rosie. Bought time for sure, yes, but some of the tumours didn't respond."

warning

Important context

  • The ~75% tumor shrinkage figure is self-reported by the owner and has not been verified in a peer-reviewed publication.
  • The vaccine was co-administered with checkpoint inhibitors. It is not possible to attribute the response to the vaccine alone.
  • This was a single animal case, not a controlled study. Individual responses do not establish efficacy.
  • The case involved a veterinary application. Animal cancer biology differs from human cancer biology.

The significance of the Conyngham case is not the unverified clinical result. It is the demonstration that consumer AI tools (ChatGPT, AlphaFold) can now meaningfully participate in the vaccine target identification process — a step previously limited to specialized bioinformatics teams. This suggests the field may become more accessible over time.

Sources: Fortune, Mar 2026 | Decrypt, Mar 2026

Market Landscape

$208M

Market size (2024)

$1.45B

Projected by 2030

44.9%

CAGR

250+

Companies in development

The personalized cancer vaccine market is one of the fastest-growing segments in oncology. Growth is driven by advances in next-generation sequencing, AI-powered neoantigen prediction, and the success of early clinical trials. Market size estimates vary significantly across research firms depending on how "personalized cancer vaccine" is defined — some reports include the broader therapeutic cancer vaccine category.

Source: Grand View Research, Personalized Cancer Vaccine Market Report

Timeline to FDA Approval

2026 (Now)

Only ~30 patients/year served via expanded access. Phase 3 trial active, not recruiting.

2029 (Estimated)

INTerpath-001 Phase 3 primary completion (October 2029). If positive, BLA filing could follow.

2030+ (Base Case)

First potential FDA approval for adjuvant melanoma. Additional cancer types would require separate trials and approvals over subsequent years.

2030-2035+

Approvals gradually expand across cancer types. Expanded access remains the pathway for unapproved indications.

Federal Research Funding Risk

Two federal actions in 2025 have introduced uncertainty into the personalized cancer vaccine pipeline:

  • NCI funding cuts: A 31% decrease in cancer research funding through March 2025 compared to the prior year, representing approximately $300 million in lost funding. (Scientific American)
  • mRNA grant terminations: HHS Secretary terminated 22 BARDA grants supporting mRNA vaccine development worth approximately $500 million in August 2025. (STAT News, Aug 2025)

These actions primarily affect publicly funded academic research, not the privately funded Moderna/Merck Phase 3 trial. However, they could slow progress in the broader field and reduce the pipeline of next-generation approaches. Paradoxically, disruption of federally funded research may increase demand for private expanded access pathways.

Open-Source Pipeline: OpenVaxx

In March 2026, software engineer Phil Fung published OpenVaxx — an open-source, end-to-end guide to producing a personalized mRNA cancer vaccine using publicly available tools. The guide was shared by Yishan Wong (former Reddit CEO) and documents the complete 8-step pipeline from tumor sequencing to finished vial.

The software tools in the OpenVaxx pipeline — including GATK Mutect2 for mutation detection, pVACseq for neoantigen prediction, and MHCflurry for immune binding prediction — are the same tools used by established programs like the Jaime Leandro Foundation's partner chain. These are not experimental; they are the current standard in computational neoantigen identification.

Why the cost difference?

OpenVaxx estimates a raw outsourced pipeline cost of approximately $5,000–$10,000 per patient. The JLF expanded access program charges $92,000–$119,000. The gap is not markup — it reflects the difference between a research-grade output and a treatment-grade product:

Component OpenVaxx (Research) JLF (Treatment)
Manufacturing environment Standard lab GMP-certified cleanroom (ISO 7)
Sterility testing Not included 2-3 week testing per batch
FDA IND filing Not included Individual patient IND per case
Physician administration Not included 7-dose protocol + monitoring
Immune monitoring Not included Ongoing T-cell response tracking
Can be injected into a patient? No Yes

OpenVaxx is an important educational resource that demonstrates the science is accessible and the core software tools are free. However, the output of a research pipeline cannot legally or safely be administered to a patient without GMP manufacturing, quality control, and FDA authorization. The $92,000–$119,000 cost reflects these compliance requirements, not the underlying science.

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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