BioNTech Cancer Treatment Gets US FDA Fast Track Designation
By Chris Wack
BioNTech and Duality Biologics (Suzhou) said that the U.S. Food and Drug Administration granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer.
BNT324/DB-1311 is a next-generation antibody-drug conjugate candidate and is currently being evaluated in a continuing Phase 1/2 study in patients with advanced solid tumors.
Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need.
The companies said the designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial with BNT324/DB-1311 in patients advanced or metastatic solid tumors.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 24, 2024 07:11 ET (11:11 GMT)
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