Bio-Thera Solutions Receives IND Clearance From US FDA to Initiate a Phase II Study for BAT8006, an Innovative Antibody Drug Conjugate Targeting Folate Receptor a [Yahoo! Finance]
Biogen Inc. (BIIB)
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Source: Yahoo! Finance
of innovative therapies and biosimilars, today announced receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor a (FRa). 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. FRa 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 FRa an attractive target for cancer drug development. BAT8006 is developed using Bio-Thera's proprietary anti-FRa 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 st
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