Bio-Thera Solutions has dosed the first patient in a Phase 1 clinical trial of BAT8013, a next-generation antibody-drug conjugate (ADC) designed to target CD25 in patients with advanced solid tumors.
The milestone marks a major step forward for the company’s oncology pipeline as it evaluates the safety, tolerability and early clinical potential of BAT8013, an experimental therapy built to target the tumor microenvironment and enhance anti-cancer immune responses.
The multicenter, open-label Phase 1 study will assess BAT8013 in patients with advanced solid tumors, with researchers aiming to determine the recommended Phase 2 dose, maximum tolerated dose, pharmacokinetics and preliminary signs of anti-tumor activity.
CD25, also known as the interleukin-2 receptor alpha chain (IL-2Rα), is a protein expressed on activated immune cells, regulatory T cells (Tregs) and certain blood cancers. In solid tumors, CD25 is overexpressed on Tregs within the tumor microenvironment, making it a potential target for immune-based cancer therapies.
Bio-Thera developed BAT8013 using its proprietary anti-CD25 antibody and ADC technology platform, combining a stable, cleavable linker with a topoisomerase I inhibitor payload. The company says the approach is designed not only to eliminate targeted Treg cells but also to trigger a bystander effect, allowing the released payload to attack nearby cells.
Preclinical studies showed BAT8013 demonstrated strong anti-tumor activity and favorable safety characteristics, including enhanced activity when combined with Bio-Thera’s PD-1 inhibitor BAT1308. The company believes the candidate could become a potential “best-in-class” CD25-targeting ADC.
