BioNTech SE (BNTX)

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BioNTech Gets FDA Fast-Track Designation for BNT111 in Advanced Melanoma

Source: Dow Jones News
By Colin Kellaher


BioNTech SE on Friday said the U.S. Food and Drug Administration granted fast-track designation to BNT111, the lead product candidate from its FixVac platform, for the potential treatment of advanced melanoma, the deadliest form of skin cancer.

The Mainz, Germany, immunotherapy company said it is investigating BNT111 in a Phase 2 trial in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

BioNTech, best known for the Covid-19 vaccine it developed in partnership with Pfizer Inc., said its FixVac platform uses a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer.


Write to Colin Kellaher at [e-mail]


(END) Dow Jones Newswires

November 19, 2021 06:59 ET (11:59 GMT)

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