On March 25, 2024 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor α (FRα) (Press release, BioThera Solutions, MAR 25, 2024, View Source;302098092.html [SID1234641420]). The phase II study will investigate the use of BAT8006 for the treatment of subjects with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.
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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 tissues. This differential expression makes FRα an attractive target for cancer drug development. BAT8006 is developed using Bio-Thera’s proprietary anti-FRα antibody and proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. Preclinical studies have shown that BAT8006 demonstrates good stability and safety along with strong anti-tumor activity. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong cell membrane penetration ability, which enables the payload to kill nearby cancer cells after the cancer cells initially targeted by the ADC are killed. This bystander effect gives BAT8006 the potential to effectively overcome the heterogeneity of the tumor. Currently, a phase I study of BAT8006 is ongoing in China. In that trial, the dose escalation study has completed and the dose expansion and dose optimization study in a series of tumors are ongoing. The preliminary data indicated that BAT8006 could potentially be a best-in-class drug. Updated clinical data will be presented at future academic conference.