China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced positive Phase I clinical data for BAT8006 (Folate-Receptor-α-ADC) at the Bethune Obstetrics and Gynecology Forum in China. The study evaluated the safety and efficacy of the antibody-drug conjugate (ADC) in a dose escalation trial.
BAT8006: A Promising ADC for Solid Tumors
BAT8006 is composed of an anti-FRα antibody and a linker-payload combination, featuring a proprietary cleavable linker that is highly systemically stable and a small molecule topoisomerase I inhibitor. FRα, a folic acid-binding protein overexpressed in various solid tumors such as ovarian, lung, and breast cancer, is the target for this ADC, with limited distribution and lower expression in normal human tissues.
Phase I Clinical Study Results
As of July 6, 2023, the dose-escalation study had recruited 29 subjects with advanced solid tumors across four cohorts, with ovarian cancer patients comprising approximately 60% of the study’s subjects. The Overall Objective Response Rate (ORR) was 31.0%, and the Disease Control Rate (DCR) was 86.2%. In the ovarian cancer subgroup, particularly among the twelve subjects with TPS >25%, the ORR reached 58.3%, and the DCR was 91.7%. It is estimated that approximately 75% of ovarian cancer patients have FRα expression >25%.
Safety Profile and Additional Findings
BAT8006 demonstrated a manageable safety profile, with the main treatment-related adverse events (TRAEs) being hematological toxicity, such as neutropenia, thrombocytopenia, anemia, and gastrointestinal toxicity, including nausea and vomiting. No cases of interstitial lung disease, ocular toxicity, or severe hepatotoxicity were observed, and no subjects were withdrawn from the study due to TRAEs.-Fineline Info & Tech
