EVX-01
InvestigationalAlso known as: EVX01, Evaxion EVX-01, AI-Immunology Neoantigen Vaccine
A personalized neoantigen peptide vaccine developed by Evaxion Biotech using AI-driven neoantigen prediction. Phase 1 data in melanoma showed 67% overall response rate when combined with anti-PD-1 therapy, with neoantigen-specific T-cell responses detected in all patients. Distinct from mRNA-based approaches like mRNA-4157.
Research Statistics
Phase 2 NSCLC peptide vaccine with multi-country trials and clear HER-2 targeting mechanism.
Research Dossier
Overview
What is EVX-01 and what does the research say?
Mechanism of Action
The proposed mechanisms of EVX-01 are based on Phase 1/2a clinical data and established neoantigen vaccine immunology. The personalized approach uses AI-driven prediction to identify patient-specific tumor targets.
How It Works (Simplified)
EVX-01 is a personalized cancer vaccine that trains the immune system to attack tumor-specific targets:
PIONEER platform analyzes tumor DNA to predict which mutations will generate immunogenic neoantigens unique to your cancer.
Long peptides are taken up by dendritic cells at injection site, processed, and presented on MHC-I and MHC-II molecules.
Both CD8+ cytotoxic and CD4+ helper T cells are activated, creating a coordinated immune response against tumor neoantigens.
Combined with anti-PD-1 therapy, vaccine-primed T cells can effectively attack tumor cells without immunosuppressive brakes.
Scientific Pathways
Neoantigen Identification Pipeline (AI-Driven Target Selection)
Tumor Biopsy → WES + RNA-Seq → Mutation Calling → PIONEER AI Analysis
↓
MHC binding + Immunogenicity scoring
↓
Top 10-15 neoantigen peptides selectedImmune Response Generation (T-Cell Activation)
EVX-01 + Adjuvant → DC Uptake → Lymph Node Migration → MHC Presentation
↓
CD8+ and CD4+ T-Cell Priming
↓
Tumor Trafficking + KillingKey Research: Phase 1/2a trial (NCT03715985) demonstrated 100% T-cell immunogenicity and 67% ORR in melanoma.
Important Limitations
- Single-arm Phase 1/2a trial with only 12 evaluable patients
- No randomized comparison to pembrolizumab alone
- Historical control comparison has inherent limitations
- Personalized manufacturing adds 6-8 weeks from biopsy to first dose
- Scalability and cost-effectiveness not yet demonstrated
Evidence-Chained Benefits
Evidence-Chained Benefits
Research findings linked to mechanisms and clinical outcomes
What to Expect
Timeline based on observations from published studies. Individual responses may vary.
Initial vaccination series (weeks 1, 2, 3, 4). Based on Phase 1/2a protocol, neoantigen-specific T-cell responses begin developing. Early immune priming occurs.
Continued vaccination schedule (weeks 6, 8, 11, 14). T-cell expansion and maturation. Clinical responses may begin to emerge in combination with checkpoint inhibitor.
Maintenance vaccinations (weeks 20, 26). In Phase 1/2a, objective responses were typically evident by week 12-24. Durable T-cell memory formation.
Long-term follow-up showed 88% of responders maintained response at 12 months, 63% at 24 months. T-cell responses persisted beyond 1 year.
Research-Based Observations
This timeline reflects observations from published clinical and preclinical studies. Individual responses may vary significantly. This is not a guarantee of effects or a dosing schedule. Consult qualified healthcare providers for personalized guidance.
Quality Checklist
Visual indicators to help evaluate EVX-01 product quality
Good Signs (6 indicators)
Warning Signs (4 indicators)
Bad Signs (6 indicators)
For Research Evaluation Only
These quality indicators are general guidelines based on typical peptide characteristics. Professional laboratory testing (HPLC, mass spectrometry) provides definitive quality verification. This checklist is for initial visual evaluation only.
Peptide Interactions
Known and theoretical interactions when combining EVX-01 with other peptides. Based on published research and mechanistic considerations.
Pembrolizumab
SynergisticEVX-01 is designed for combination with anti-PD-1 therapy. Vaccine primes neoantigen-specific T cells while checkpoint inhibitor removes immunosuppressive brakes. Phase 1 data from this combination.
MRNA-4157
CompatibleAlternative neoantigen vaccine platform (mRNA vs peptide). Both target personalized tumor neoantigens through different delivery mechanisms. Not typically combined.
Research Note: Interaction data is based on published literature, mechanistic understanding, and theoretical considerations. Most peptide combinations lack direct clinical study. This information is for educational purposes only and does not constitute medical advice. Always consult qualified healthcare providers.
References
Key Studies Cited
Full reference list available on request. All citations link to PubMed for verification.
Methodology Note
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength ratings follow a modified GRADE approach.
For complete methodology details, see our Methodology page.
Important Disclaimer
This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.
Get Research Alerts
New dossiers and major study summaries delivered to your inbox. Evidence-graded, citation-backed research you can trust.
No spam. Unsubscribe anytime.
Compare EVX-01
Related Peptides
225Ac-DOTA-LM3
Actinium-225-DOTA-LM3, 225Ac-DOTA-JR11, Alpha-PRRT +1 more
An alpha-emitting radiolabeled somatostatin receptor antagonist for peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumors. Unlike conventional beta-emitting Lu-177 therapies and SSTR agonists, 225Ac-DOTA-LM3 combines the higher cell-killing power of alpha particles with antagonist binding for enhanced tumor targeting. Clinical stage investigational therapy showing promise in Lu-177-refractory patients.
Bronchogen
AEDL, Ala-Glu-Asp-Leu, Bronchial tetrapeptide +1 more
A synthetic tetrapeptide (Ala-Glu-Asp-Leu) developed by Russian scientist Vladimir Khavinson for bronchial and respiratory tissue support. Claimed to modulate bronchial epithelium gene expression and provide respiratory protective effects. No Western clinical validation; all evidence from Russian bioregulator research.
BT5528
Bicycle Toxin Conjugate 5528, EphA2-BTC
A first-in-class Bicycle Toxin Conjugate (BTC) targeting EphA2-expressing tumors, developed by Bicycle Therapeutics. Combines a constrained bicyclic peptide targeting moiety with the cytotoxic payload MMAE. Phase 1/2 dose expansion ongoing with 67% ORR reported in EphA2-positive urothelial cancer patients.
Cardiogen
AED, Ala-Glu-Asp, Cardiac tripeptide
A synthetic tripeptide (Ala-Glu-Asp) developed by Russian scientist Vladimir Khavinson for cardiac tissue support. Claimed to target cardiomyocyte gene expression and provide cardioprotective effects. No Western clinical validation exists; evidence limited to Russian preclinical and observational studies.
Chonluten
EDG-GI, Glu-Asp-Gly (GI), GI tract tripeptide +1 more
A synthetic tripeptide (Glu-Asp-Gly) developed by Vladimir Khavinson for gastrointestinal tissue support. Shares the same amino acid sequence as Kristagen but is marketed for digestive system rather than immune function. Limited to Russian studies with no Western validation or clinical trials.
Livagen
KED, Lys-Glu-Asp, Hepatogen
A synthetic tripeptide (Lys-Glu-Asp) developed by Russian scientist Vladimir Khavinson, claimed to support liver function and modulate hepatic gene expression. Minimal Western validation exists; all research originates from Russian institutions with no controlled human clinical trials.