Personalized Cancer Vaccines Exist. Most Patients Don't Know.
Custom-built immunotherapies that target your tumor's unique mutations are available today through FDA expanded access. ImmunaPath helps you navigate the process — from diagnosis to treatment.
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
New US cancer diagnoses/year
(ACS 2025)
Patients eligible for personalized vaccines annually
Patients served by existing programs
"The gap between demand and access is enormous."
From Diagnosis to Treatment in 6 Steps
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
Series of 7 doses over several months to train the immune system.
Monitoring
CT scans and blood tests to measure tumor regression and TCR activity.
Total timeline: 4–5 months
Total cost: $100,000–$119,000
Tools to Help You Decide
Navigating personalized oncology requires precision and data.
Eligibility Checker
Answer 7 key questions about your diagnosis and treatment history to see if you may qualify for expanded access programs.
Cost Calculator
Estimate your total treatment cost including sequencing, manufacturing, and hospital administration fees based on your location.
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 like the Jack L. Fowler Foundation (JLF) and various academic medical centers coordinate with vaccine manufacturers to facilitate these single-patient protocols.
ImmunaPath serves as a bridge between oncologists, the FDA, and precision labs to ensure every regulatory and logistical requirement is met.
Clinical Trials
| Manufacturer | Phase | Status |
|---|---|---|
| Moderna / Merck | Phase 3 | Recruiting |
| BioNTech | Phase 2 | Active |
| Mount Sinai (PGV001) | Phase 1 | Selective |
Last updated: March 2026. Data provided for informational purposes only.
Stay Informed
New developments in neoantigen science emerge monthly. Get research updates, regulatory changes, and expanded access availability directly in your inbox.
Medical Disclaimer: Subscribing to this newsletter does not establish a doctor-patient relationship. ImmunaPath provides information and logistical support, not medical diagnosis or treatment.