Advanced Melanoma Immunotherapy Granted Fast-Track Status

Germany-based BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, a cancer immunotherapy candidate for the potential treatment of advanced melanoma.

BNT111 is the lead product candidate from BioNTech’s fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer.

The candidate is currently being investigated in a Phase 2 study in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma.

“The Fast Track Designation underlines the potential of our FixVac platform to address current treatment challenges of pre-treated and immune checkpoint blocker experienced melanoma with a limited standard of care therapy options left. This is an important step to pave the way for this versatile new treatment approach in a high medical need setting,” commented Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, in a related press statement.

The ongoing randomized Phase 2 trial (BNT111-01) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma investigates BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being co-developed by Regeneron and Sanofi.

The BNT111-01 trial is conducted in the U.S., the U.K., Australia, Spain, Germany, Italy, and Poland.

This new trial seeks to support initial data reported from the ongoing Phase 1 Lipo-MERIT monotherapy dose-escalation trial that demonstrated a favorable safety profile and anti-tumor responses of BNT111 alone and in combination with immune checkpoint inhibitor therapy in patients with advanced melanoma.

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

BNT111 is not yet authorized by any regulatory authority, and the safety and efficacy have not yet been established.

Biopharmaceutical New Technologies is a next-generation immunotherapy company located in Mainz, Germany, pioneering novel therapies for cancer and other serious diseases.