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.
BNT116
Also known as: LuCa mRNA vaccine · BioNTech lung cancer vaccine
BNT116 is BioNTech's lung cancer mRNA vaccine — a non-personalised approach targeting 6 antigens commonly overexpressed in NSCLC. Lung cancer is the world's leading cancer killer, with over 1.8 million deaths per year. Unlike personalised vaccines (which take 6+ weeks to manufacture), BNT116 can be manufactured at scale and potentially used in large populations. The Phase 1 LuCa trial, initiated in 2023 across Germany, UK, Hungary, Poland, and Spain, is evaluating safety, optimal dosing, and immunogenicity in patients with resectable or locally advanced NSCLC. This is part of BioNTech's EU Cancer Mission commitment and represents one of the first cancer vaccine trials targeting lung cancer with mRNA technology.
What It Targets
Target Antigen
6 shared NSCLC tumour-associated antigens (non-personalised fixed mRNA)
Cancers Targeted
How It Works
Six mRNA sequences encoding tumour-associated antigens overexpressed in NSCLC — including cancer-testis antigens and NSCLC-specific differentiation antigens — are formulated in lipid nanoparticles. Given as monotherapy or combined with anti-PD-1/PD-L1 checkpoint inhibitors. The fixed antigen approach allows scalable manufacturing and enables pre-manufacturing for broad patient access — a key advantage over personalised vaccines in the lung cancer setting where patients often have poor performance status limiting manufacturing time.
Key Trial Results
- Phase 1 LuCa trial: initiated Q2 2023 in Germany, UK, Spain, Hungary, Poland
- Trial sites include BioNTech's partner hospitals and EU Cancer Mission-designated comprehensive cancer centres
- Safety and immunogenicity data expected 2025
- BioNTech commitment: EU Cancer Mission patient enrolment target includes BNT116 patients
- Lung cancer rationale: 1.8M deaths/year globally; mRNA vaccine could be adjuvant after resection or combined with existing immunotherapy
Regulatory Status & Availability
Approval Status
Phase 1 multi-centre trial (LuCa trial) initiated 2023 across EU and UK sites.
Estimated Availability
Phase 1 — earliest 2028+ if Phase 3 initiated promptly
Important Considerations
- Very early Phase 1 — safety is the primary endpoint; efficacy data will take years
- Fixed antigens may not be expressed uniformly across all NSCLC tumours — biomarker selection critical
- Combination with PD-1/PD-L1 inhibitors needed for efficacy in an immunosuppressive tumour microenvironment
- Lung cancer patient population often has comorbidities (smoking history, COPD) that may affect vaccine response
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.