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BL-B01D1 + pembrolizumab is a combination therapy being developed by Sichuan Baili Pharmaceutical Co., Ltd. for the treatment of advanced biliary tract cancer. BL-B01D1 is a first-in-class bispecific antibody-drug conjugate (ADC) that simultaneously targets the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It consists of the bispecific antibody izalontamab conjugated to ED-04, a novel topoisomerase I inhibitor payload, via a cleavable linker with a drug-to-antibody ratio (DAR) of 8. Pembrolizumab is a humanized monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) receptor, an immune checkpoint. This combination aims to leverage the targeted cytotoxicity of the ADC against tumor cells expressing EGFR/HER3 and the immune-potentiating effects of checkpoint inhibition to improve outcomes in patients with biliary tract malignancies.
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