Investigational — This vaccine is not yet approved for general use. Information is for educational purposes only. Participation in clinical trials requires enrolment at an authorised trial centre.
BNT111
Also known as: FixVac · Fixed neoantigen mRNA melanoma vaccine
Unlike mRNA-4157 and BNT122, BNT111 (FixVac) uses a fixed, non-personalised mRNA formulation targeting 4 antigens commonly overexpressed on melanoma cells but not present on normal tissue. The advantage: no patient-specific manufacturing — one batch can treat many patients. Phase 1 showed objective responses in patients with immune checkpoint inhibitor-resistant melanoma. It is now in Phase 2 combined with cemiplimab (Libtayo). Being developed under EU funding and is part of BioNTech's EU cancer vaccine pipeline.
What It Targets
Target Antigen
4 shared melanoma antigens: NY-ESO-1, MAGE-A3, tyrosinase, TPTE
Cancers Targeted
How It Works
Four mRNA sequences encoding cancer-testis antigens (NY-ESO-1, MAGE-A3) and differentiation antigens (tyrosinase, TPTE) — proteins normally silent in adult tissue but re-activated in melanoma — are encapsulated in RNA-lipoplexes (RNALPs). Intravenous delivery targets lymphoid organs (spleen, lymph nodes) where dendritic cells take up the mRNA and present antigens to T cells. CD8+ cytotoxic T cells are primed to kill cells expressing these antigens. Combined with cemiplimab to prevent T-cell exhaustion.
Key Trial Results
- Phase 1: objective responses in immune checkpoint inhibitor-relapsed/refractory melanoma patients — a population with very few options
- 2 complete responses and 3 partial responses in 89 evaluable patients; durable in checkpoint-naive patients
- Combination with cemiplimab (Phase 2) currently enrolling
- EU Cancer Mission: BioNTech committed to enrolling 10,000 EU patients in cancer vaccine trials by 2030 under new EU framework
- Unlike personalised vaccines, scalable manufacturing could dramatically reduce cost and access barriers
Regulatory Status & Availability
Approval Status
Phase 2 (BNT111-01) ongoing in combination with cemiplimab (anti-PD-1). EU-funded.
Estimated Availability
Phase 2 — potential availability 2027+ if trials succeed
Important Considerations
- Fixed antigens may not be present in all melanoma tumours — patient selection by biomarker profiling important
- Phase 2 — efficacy data maturing; not yet approved
- Antigen escape (tumour losing target antigen expression) is a theoretical resistance mechanism
- IV formulation (RNA-lipoplexes) requires clinic administration
Research References
iOnco provides this information for educational purposes only. Cancer vaccine availability, trial eligibility, and access pathways change frequently. Always discuss vaccination decisions and clinical trial participation with your oncologist or healthcare provider.