China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate Phase I/II clinical trials for BAT6026, an OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD).
The Role of OX40 in Immune Response and BAT6026’s Mechanism
OX40, an immune checkpoint expressed on activated immune cells, plays a crucial role in stimulating the division of downstream T cells, enhancing their proliferation and survival. It also inhibits the suppressive function of Tregs, thereby dampening the immune system’s inhibitory effects. BAT6026 is under development to treat advanced malignant solid tumors and AD. The drug not only blocks the OX40/OX40L signaling pathway, inhibiting T cell activation and proliferation, but also exhausts activated OX40+ T cells through an enhanced antibody-dependent cellular cytotoxicity (ADCC) effect.
Positive Preliminary Results from BAT6026 Studies
BAT6026 has successfully concluded a Phase I study dosage escalation in tumors, with no dose-limited toxicity observed. In autoimmune disease models, the survival rate of graft versus host disease (GVHD) mice treated with high, medium, and low doses of BAT6026 was 100%, and the mice exhibited almost no symptoms of GVHD. These results indicate the potential safety and efficacy of BAT6026 in treating not only AD but also advanced malignant solid tumors.-Fineline Info & Tech
