On August 2, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8009, an antibody drug conjugate (ADC) that targets B7-H3 (CD276) (Press release, BioThera Solutions, AUG 2, 2022, View Source [SID1234617305]). 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.
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B7-H3 is an immunomodulatory transmembrane N-linked glycoprotein that is overexpressed in a number of 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.
The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8009 is designed to assess the safety and tolerability of BAT8009. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. Of note, Bio-Thera Solutions is developing several additional ADCs targeting Folate Receptor, HER2 and two other targets along with additional innovative oncology assets directed at important IO targets, including PD-1/CD47, OX40, CTLA-4, and TIGIT assets that are in early-stage clinical studies.