Bio-Thera Solutions receives FDA clearance for Phase II Study of BAT8006, a Novel ADC Targeting Folate Receptor α

CAR-T Digest - August 2020

25 Mar 2024: Bio-Thera Solutions receives FDA clearance for Phase II Study of BAT8006, a Novel ADC Targeting Folate Receptor α

Bio-Thera Solutions receives FDA IND clearance for phase II study of BAT8006, an ADC targeting Folate Receptor α (FRα)
The Phase II study will focus on platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer subjects
FRα, overexpressed in various solid tumors but with limited distribution in normal tissues, makes an attractive target for cancer drug development
BAT8006, utilizing Bio-Thera’s anti-FRα antibody and ADC linker-payload combination, showed stability, safety, and strong anti-tumor activity in preclinical studies
BAT8006’s topoisomerase I inhibitor payload facilitates a bystander effect, potentially overcoming tumor heterogeneity
Ongoing phase I study in China indicates BAT8006’s potential as a best-in-class drug; updated clinical data to be presented at future academic conferences.