RBL002

RBL002 is an investigational naked mRNA-based cancer vaccine developed by BioNTech for the treatment of advanced melanoma. It was evaluated as part of the first-in-human Phase 1 MERIT (Melanoma RNA Immunotherapy) dose-escalation study, where it was typically administered intranodally in combination with RBL001. RBL002 specifically encodes for tyrosinase (TYR), a tumor-associated antigen that is frequently overexpressed in melanoma cells. The vaccine's mechanism of action involves the uptake of the naked RNA by dendritic cells within the lymph nodes, leading to the expression of the tyrosinase antigen and the subsequent induction of antigen-specific CD4+ and CD8+ T-cell responses. This early naked RNA technology served as a proof-of-concept for BioNTech's more advanced FixVac platform, which evolved into candidates like BNT111 that utilize an RNA-lipoplex delivery system.