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DualityBio and BioNTech announce US Fast Track Status for ADC in Ovarian Cancer

publication date: Jan 31, 2024

Suzhou Duality Biologics and Germany’s BioNTech received US Fast Track designation for their partnered ADC drug candidate in platinum-resistant ovarian cancer indications. The companies describe BNT325/DB-1305 as a next-gen ADC candidate that targets the trophoblast cell-surface antigen 2 (TROP2), a protein that is overexpressed on a range of tumor types. Currently, the candidate is in a US Phase I/II trial in patients with TROP2-expressing advanced solid tumors. In March 2023, Duality out-licensed global rights (ex-China) for two ADC candidates to BioNTech in a $1.7 billion deal ($170 million upfront). More details....

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