BNT111 + cemiplimab

**BNT111 + cemiplimab** is an investigational combination therapy for advanced or unresectable melanoma. BNT111 is an mRNA-based cancer immunotherapy vaccine that encodes four tumor-associated antigens (TAAs) frequently found in melanoma; its delivery uses uridine mRNA technology and proprietary lipoplex formulation, designed to stimulate an antigen-specific immune response against melanoma cells. Cemiplimab is a monoclonal antibody targeting the PD-1 receptor (an immune checkpoint), enhancing T cell activity by blocking PD-1-mediated inhibition, thus promoting antitumor immunity. The combination significantly improved overall response rate in Phase 2 trials for patients with advanced melanoma relapsed or refractory to anti-PD-1 therapies, with a safety profile consistent with prior studies. BNT111 is being developed by BioNTech, and cemiplimab by Regeneron. The FDA granted fast track designation to the combination for anti–PD-1-refractory/relapsed, unresectable stage III or IV melanoma[1][2][3][4][5].

Other names

BNT111 + Libtayo