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BioNTech Gets FDA Fast Track Designation For BNT111 Candidate To Treat Advanced Melanoma

BioNTech SE (BNTX), a German developer and manufacturer of active immunotherapies, said on Friday that the U.S. Food and Drug Administration, or FDA, has 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 company said in a statement.

Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, commented: "With the Fast Track status and support by the FDA, we aim to expedite the further development of the BNT111 program to provide a new therapeutic option for patients with life-threatening, hard-to-treat melanoma."

The vaccine candidate is currently being investigated in a phase two trial in patients with anti-PD-1-refractory, relapsed unresectable stage three or four melanoma.

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