RBL001

RBL001 is a naked messenger RNA (mRNA) vaccine component developed by BioNTech for the treatment of advanced melanoma. It specifically encodes the cancer-testis antigen NY-ESO-1 (Cancer/testis antigen 1) and is designed to induce antigen-specific CD4+ and CD8+ T-cell immune responses. In early clinical development, specifically the Phase 1 MERIT trial, RBL001 was administered via intranodal injection, typically in combination with RBL002 (which encodes the Tyrosinase antigen). This approach is part of BioNTech's FixVac platform, which utilizes shared tumor-associated antigens to trigger a systemic immune response against cancer cells. RBL001 was subsequently integrated into the liposomal mRNA vaccine BNT111 (Lipo-MERIT), which targets four melanoma-associated antigens (NY-ESO-1, Tyrosinase, MAGE-A3, and TPTE) and is administered intravenously.