mRNA Melanoma Vaccine Candidate Launches Phase 2 Study

Germany-based BioNTech SE announced the first patient had been treated in its BNT111 Phase 2 cancer vaccine trial. The study evaluates the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III-IV melanoma.

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer. 

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as an RNA-lipoplex formulation.

The BNT111-01 trial, which is being conducted in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in Spain, Germany, Italy, Poland, and the United Kingdom, the USA, Australia.

“Our vision is to harness the power of the immune system against cancer and infectious diseases. We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19. We must not forget that cancer is also a global health threat, even worse than the current pandemic,“ said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, in a press release.

Mainz, DE-based Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.  BioNTech’s fully-owned mRNA cancer vaccine platform is separate from the Pfizer-BioNTech COVID-19 vaccine program.