Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that it has received approval from the National Medical Products Administration (NMPA) for its BAT8010 to enter clinical trials for the treatment of general solid tumors. The drug, independently developed by Bio-Thera, is an HER2-targeted antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2 antibody and a cytotoxic small molecule topoisomerase I inhibitor connected by a self-developed cleavable linker.
Pipeline Update
Bio-Thera also revealed that its ADCC-enhanced anti-HER2 monoclonal antibody (mAb) BAT1006 is currently in the early clinical stages. BAT1006 and BAT8010 act on different sites of HER2 and can effectively inhibit the formation of HER2/HER3 heteromers, potentially producing synergistic effects when used in combination.
Additional ADC Programs
Bio-Thera is also developing BAT8006 and BAT8009, ADCs targeting folate receptor alpha (FRα) and B7H3, respectively. However, the company’s in-house developed BAT8001, an ADC composed of an anti-HER2 monoclonal antibody covalently linked to the toxin-linker batansine (a maytansine derivative) through a stable thioether bond, failed to meet the pre-set superiority goal in a Phase III clinical study for breast cancer. Bio-Thera terminated the clinical trial after investing RMB 226 million (USD 33.7 million) in the drug’s development.-Fineline Info & Tech
