BioNTech SE announced that the FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy 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 vaccine candidate is currently being investigated in a Phase 2 trial (EudraCT No.: 2020-002195-12; NCT04526899) 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 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,” said ?zlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech. “With the Fast Track status and support by the FDA, we aim to expedite the further development of the BNT111 program to provide a new therapeutic option for patients with life-threatening, hard-to-treat melanoma.”

Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need. The FDA’s decision is based on available preclinical and clinical data showing the potential of BNT111 to overcome current limitations in the treatment of inoperable therapy-resistant advanced-stage melanoma. With the Fast Track Designation, the development of BNT111 can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate BNT111’s development.

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 which is conducted in collaboration with Regeneron is enrolling a total of 180 patients into three treatment arms in the United States, the United Kingdom, Australia, Spain, Germany, Italy and Poland. This trial seeks to support initial data reported from the ongoing Phase 1 Lipo-MERIT monotherapy dose escalation trial (EudraCT No. 2013-001646-33; NCT02410733; DOI: 10.1038/s41586-020-2537-9) 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.