Bio-Thera Launches Phase IB/IIA Trial for OX40-targeting BAT6026 in Atopic Dermatitis

Bio-Thera Solutions, a biopharmaceutical firm based in Guangzhou, China, has initiated a Phase IA/IIB clinical trial for BAT6026, a monoclonal antibody aimed at treating patients with moderate to severe atopic dermatitis. The OX40 protein, which is highly expressed in activated T cells and is linked to numerous inflammatory conditions, is the target of BAT6026. This antibody not only inhibits the interaction between OX40 and OX40L to prevent T cell activation and proliferation but also specifically eliminates activated OX40+ T cells, enhancing the antibody-dependent cell-mediated cytotoxicity (ADCC) effect. This dual action suggests BAT6026's potential in treating a range of inflammatory diseases, particularly those driven by Th2 cells.

The clinical trial, conducted across multiple centers, is focused on evaluating the efficacy and safety of BAT6026. The primary goals include assessing the drug's safety profile, tolerability, how it is metabolized within the body (pharmacokinetics), and its initial anti-inflammatory capabilities.

Bio-Thera Solutions is renowned for its commitment to developing innovative treatments for a variety of severe medical conditions, including cancer, autoimmune diseases, cardiovascular disorders, and eye diseases. The company also specializes in creating biosimilars for existing biologic drugs used to combat cancer and autoimmune diseases. With a strong presence in the field of antibody discovery and engineering, Bio-Thera has several candidates in advanced stages of development. Among these are three approved products: QLETLI® in China, and TOFIDENCE™/BAT1806 and Avzivi®/Pobevcy® in both the US and China. Furthermore, the company has over 20 promising candidates undergoing clinical trials, with a focus on immuno-oncology post the PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs).