BioNTech SE was granted Fast Track Designation from the FDA for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTech’s FixVac platform that uses 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 in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV 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 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, conducted in collaboration with Regeneron is enrolling 180 patients into three treatment arms in the U.S., the UK, Australia, Spain, Germany, Italy and Poland.