Research & Development
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
26 March 2024 -

Bio-Thera Solutions (688177:SH), a China-based commercial-stage biopharmaceutical company, announced on Monday that it has received IND approval from the US FDA for a phase II study of BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor alpha (FR alpha).

The phase II study is to assess the use of BAT8006 for the treatment of subjects with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

BAT8006 has been developed utilising Bio-Thera's proprietary anti-FR alpha antibody and proprietary ADC linker-payload combination that comprises of a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. The company says that preclinical studies have shown that BAT8006 demonstrates good stability and safety along with strong anti-tumour activity.