Bio-Thera Solutions Doses First Patient in Phase 1 Trial of CD25-Targeting ADC BAT8013 for Advanced Solid Tumors
核心洞察
Bio-Thera Solutions (搜索) has initiated dosing in a multicenter, open-label Phase 1 study of BAT8013 (搜索), an antibody-drug conjugate targeting CD25 (搜索), in patients with advanced solid tumors (搜索).
BAT8013 (搜索) employs a proprietary cleavable linker and topoisomerase I inhibitor payload designed to eliminate regulatory T cells in the tumor microenvironment and produce a bystander killing effect.
Preclinical studies demonstrated high anti-tumor activity and good safety, with enhanced efficacy observed when combined with Bio-Thera's PD-1 inhibitor BAT1308.
Bio-Thera Solutions (搜索), Ltd. (SH: 688177) announced today that the first patient has been dosed in a Phase 1 clinical study evaluating BAT8013 (搜索), an antibody-drug conjugate (ADC) targeting CD25 (搜索), for the treatment of advanced solid tumors (搜索). The milestone marks the company's continued expansion into the ADC space within immuno-oncology.
The multicenter, open-label, dose-escalation trial is designed to assess the safety and tolerability of BAT8013 (搜索), with key objectives including determination of the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as evaluation of pharmacokinetics and preliminary efficacy in patients with advanced solid tumors (搜索).
Targeting Tregs in the Tumor Microenvironment
CD25 (搜索), also known as the interleukin-2 receptor alpha chain (IL-2Rα), is a 55 kDa transmembrane glycoprotein encoded by the IL2RA gene. It is predominantly expressed on activated T and B cells, regulatory T cells (Tregs), and various hematologic malignancies. Critically, CD25 is differentially overexpressed on Tregs within the solid tumor microenvironment, making it an attractive target for immunotherapeutic intervention.
BAT8013 (搜索) was developed using Bio-Thera's anti-CD25 (搜索) antibody paired with the company's proprietary ADC linker-payload combination. This system incorporates a systemically stable and cleavable linker conjugated to a small molecule topoisomerase I inhibitor. By eliminating Tregs through CD25 targeting, BAT8013 is expected to potentiate the efficacy of other immune-oncology agents, including PD-1 and PD-L1 monoclonal antibodies.
Preclinical Evidence and Bystander Effect
A series of preclinical studies demonstrated that BAT8013 (搜索) exhibits good stability and safety, along with high anti-tumor activity when used in combination with Bio-Thera's PD-1 inhibitor, BAT1308. The topoisomerase I inhibitor payload carried by BAT8013 possesses strong cell membrane penetration capability, enabling a bystander killing effect: when target Treg cells are eliminated, the released payload can diffuse into and kill nearby Treg cells.
BAT8013 (搜索) has shown high anti-tumor activity and a favorable safety profile in both in vitro and in vivo pharmacological studies. Bio-Thera describes the candidate as a potential "best-in-class" ADC targeting CD25 (搜索).
Broader Pipeline Context
Beyond BAT8013 (搜索), Bio-Thera Solutions (搜索) is advancing several additional ADCs targeting Folate Receptor alpha, Trop2, and HER2, alongside innovative immuno-oncology assets including novel bispecific molecules targeting PD-L1/4-1BB and PD-1/IL-15, all in early-stage clinical studies. The company, headquartered in Guangzhou, China, has six approved products and more than 20 candidates in clinical trials, with a focus on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs.