China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center, open Phase I study to assess the safety, tolerability, and preliminary efficacy of BAT8008, an antibody-drug conjugate (ADC) targeting Trop2 in advanced solid tumors. The study will also help determine the recommended Phase II dosage.
Drug Development and Mechanism
BAT8008 was developed using Bio-Thera’s proprietary ADC linker payload, which includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor, and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8008 has a strong cell membrane penetration ability. When targeted cancer cells are killed, the payload is released and can kill nearby cancer cells, producing a bystander effect. This mechanism has the potential to overcome the heterogeneity of the tumor.
Preclinical Findings
In both in vitro and in vivo pharmacological studies, BAT8008 has demonstrated high anti-tumor activity, good stability, and safety. Preclinical data generated using BAT8008 was presented in a poster at the 2022 San Antonio Breast Cancer Conference.
Significance of the Study
The initiation of the Phase I clinical trial for BAT8008 marks a significant milestone in the development of this innovative ADC. It highlights Bio-Thera Solutions’ commitment to advancing effective treatments for advanced solid tumors and improving patient outcomes.-Fineline Info & Tech
