BioNTech Starts Dosing In Mid-Stage Melanoma Vaccine Trial

BioNTech SE BNTX has dosed the first patient in its Phase 2 trial evaluating the BNT111 cancer vaccine.
The study evaluates the therapeutic cancer vaccine candidate BNT111 in combination with Regeneron Pharmaceuticals Inc REGN - Sanofi SA's SNY 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.
The trial will enroll around 120 patients and evaluate the effects of the combination and single agents alone.
The primary endpoint is the overall response rate. Secondary endpoints include overall response rate in the single-agent arms, duration of response, and safety.
Price Action: BNTX shares are down by 0.56% at $213 during the premarket trading session on the last check Friday.