Bio-Thera Solutions, Ltd., a commercial-stage pharmaceutical company, announced that dosing has begun in a Phase 1 clinical study evaluating BAT8009, an antibody drug conjugate (ADC) that targets B7-H3 (CD276). The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8009 and to determine the recommended phase 2 dose.
B7-H3 is an immunomodulatory transmembrane N-linked glycoprotein that is overexpressed in a few solid tumors including small cell lung cancer, non-small cell lung cancer, breast cancer, and others but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make B7-H3 an potential target for ADC drug development. BAT8009 was developed using Bio-Thera’s proprietary anti-B7-H3 antibody and ADC linker-payload that includes a cleavable and systemically stable linker and a small molecule topoisomerase I inhibitor. The small molecule topoisomerase I inhibitor payload carried by BAT8009 has a strong cell membrane penetration ability, so when the target cancer cells are killed, the payload can potentially be released and further kill nearby cancer cells, producing a bystander effect and overcoming the heterogeneity of the tumor. BAT8009 has demonstrated high anti-tumor activity and good stability and safety in both in vitro and in vivo pharmacological studies and is a potential best-in-class ADC that targets B7-H3. BAT8009 is the second ADC drug using Bio-Thera’s proprietary new ADC platform administered to patients, representing another important milestone in the company’s research and clinical development in the field of innovative oncology drugs.
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