Personalized Cancer Vaccine Research, Explained Carefully.
Personalized neoantigen vaccines are investigational treatments being studied in specific cancer settings. ImmunaPath organizes the research, trial and expanded-access resources, current cost information, and questions to discuss with your oncologist.
The Personalized Pipeline
Biopsy
Tissue extraction and preservation
Sequencing
Whole exome & RNA analysis
Neoantigen ID
AI-driven mutation prediction
Manufacturing
Custom mRNA/Peptide synthesis
Administration
Personalized clinical dosing
Monitoring
Ongoing immune response tracking
Strongest peer-reviewed evidence
High-risk resected melanoma; not all cancers
INTerpath-001 confirmation trial
Primary completion estimated October 2029
Not a generally FDA-approved treatment
Access and suitability depend on multiple clinical and regulatory gates
Promising evidence is not the same as general availability, suitability, or proven benefit for every cancer.
How One Expanded-Access Pathway Can Work
This example reflects the Jaime Leandro Foundation's current published peptide-vaccine pathway. Other trials, sponsors, vaccine platforms, timelines, dosing schedules, and costs can differ.
Biopsy
Surgical removal of tumor tissue for molecular profiling and sequencing.
Exome Sequencing
Mapping the entire genetic code of the tumor versus healthy cells. (~4 weeks)
Neoantigen ID
Bioinformatics algorithms identify the most immunogenic mutations. (~4-6 weeks)
Manufacturing
Individualized synthesis of the vaccine (mRNA or peptide). (~12-14 weeks)
Administration
JLF currently describes a seven-dose protocol administered by an approved treating physician.
Monitoring
The treating team determines product-specific safety monitoring and clinical follow-up.
JLF timeline: roughly 4–5 months from sequencing to delivery
JLF model: roughly $92,000 before physician administration
Tools to Help You Decide
Navigating personalized oncology requires precision and data.
Oncology Question Checklist
Bring seven evidence, trial, tissue, timing, risk, and cost questions to your oncology team. No medical details are collected and no eligibility score is produced.
Cost Calculator
Explore major cost variables using adjustable educational estimates. This is not a quote or coverage determination.
Trial Finder
Find active clinical trials for neoantigen vaccines filtered by your specific cancer type and stage through ClinicalTrials.gov.
Subscribe to be notified when these tools launch.
Expanded Access Programs
Outside of clinical trials, the FDA's "Expanded Access" (often called Compassionate Use) provides a pathway for patients with serious or life-threatening diseases to gain access to investigational medical products.
Organizations such as the Jaime Leandro Foundation (JLF) publish information about their own expanded-access pathways. Clinical trials and sponsor policies are separate routes with their own criteria.
ImmunaPath is an independent educational resource. It does not determine eligibility, recommend treatment, contact sponsors, file FDA paperwork, place patients, or coordinate care.
Clinical Trials
| Manufacturer | Phase | Status |
|---|---|---|
| KEYNOTE-942 | Phase 2b | Five-year update published |
| INTerpath-001 | Phase 3 | Active, not recruiting |
| Mount Sinai PGV001 | Phase 1 | Small study published |
Checked July 2026. Trial status and registry dates can change; a listing is not proof of efficacy.
Stay Informed
New developments in neoantigen science emerge monthly. Get research updates, regulatory changes, and expanded access availability directly in your inbox.
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