On July 13, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8006, an antibody drug conjugate (ADC) that targets folic acid receptor α (FRα) (Press release, BioThera Solutions, JUL 13, 2022, View Source [SID1234616652]). 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 BAT8006 and to determine the recommended phase 2 dose.
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FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancer, etc., but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make FRα an ideal target for ADC drug development. BAT8006 was developed using Bio-Thera’s anti-FRα antibody and Bio-Thera’s proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. A series of preclinical studies have shown that BAT8006 has good stability and safety and has high anti-tumor activity. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong cell membrane penetration ability, so when the target cancer cells are killed, the payload can be released and further kill nearby cancer cells, producing a bystander effect and effectively overcoming the heterogeneity of the tumor. BAT8006 has demonstrated high anti-tumor activity and good safety in both in vitro and in vivo pharmacological studies and is a potential "best-in-class" ADC that targets FRα. BAT8006 is the first ADC drug using Bio-Thera’s proprietary new ADC platform administered to patients, representing another important milestone in the company’s research and development in the field of innovative oncology drugs.
The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8006 is designed to assess the safety and tolerability of BAT8006. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. In addition, Bio-Thera Solutions is developing several additional ADCs targeting B7H3, Her2 and two other targets along with additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early-stage clinical studies.