Biontech receives fda fast track designation for its fixvac candidate bnt111 in advanced melanoma

Mainz, germany, november 19, 2021 — biontech se (nasdaq: bntx, “biontech” or “the company”) today announced that the u.s. food and drug administration (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.
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