Bio-Thera Launches BAT6026 OX40 Targeted Monoclonal Antibody Phase IB/IIA Clinical Trial for Moderate to Severe Atopic Dermatitis Patients

Bio-Thera Solutions, a biopharmaceutical firm, has initiated a Phase IA/IIA clinical trial for BAT6026, a monoclonal antibody designed to target OX40, in individuals suffering from moderate to severe atopic dermatitis. The OX40 protein, which is significantly present in activated T cells, is a key player in inflammatory diseases such as atopic dermatitis. BAT6026 works by inhibiting the OX40/OX40L interaction, thereby preventing T cell activation and proliferation, and also by depleting activated OX40+ T cells through an enhanced antibody-dependent cellular cytotoxicity (ADCC) effect. The drug has demonstrated a promising preclinical profile and was found to be safe and well-tolerated in a prior Phase 1 clinical study.
The current multicenter clinical trial aims to evaluate the drug's efficacy and safety, focusing on its impact on safety, tolerability, pharmacokinetics, and initial anti-inflammatory effects. Bio-Thera Solutions, based in Guangzhou, China, is a prominent biopharmaceutical company that specializes in developing innovative treatments for a variety of conditions including cancer, autoimmune diseases, cardiovascular diseases, and eye disorders. The company has several products in late-stage development and has already received approval for three products: QLETLI® in China, and TOFIDENCE™/BAT1806 and Avzivi®/Pobevcy® in both the US and China. Additionally, Bio-Thera is progressing over 20 potential drug candidates in clinical trials, with a focus on immuno-oncology and targeted therapies post the PD-1 era.

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