BioNTech Starts Dosing In Mid-Stage Melanoma Vaccine Trial

• BioNTech SE (NASDAQ: 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 (NASDAQ: REGN) - Sanofi SA's (NASDAQ: 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.

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