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Duality and BioNTech Start China Arm of Phase III Trial of ADC for HER2 Breast Cancer

publication date: Jan 22, 2024

Suzhou DualityBio and its partner, BioNTech of Germany, have dosed the first metastatic breast cancer patients in a global pivotal Phase III trial of BNT323/DB-1303, a novel antibody-drug conjugate candidate targeting HER2. The trial will assess the efficacy and safety of BNT323/DB-1303 compared to standard-of-care single-agent chemotherapy. It will enroll chemotherapy-naïve patients with HR+ and HER2-low metastatic breast cancer who have progressed on hormone therapy. In April 2023, BioNTech acquired global (ex-China) rights to DB-1303 and another ADC for $170 million upfront and $1.5 billion in milestones. More details....

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