China-based Harbour BioMed (HKG: 2142) has announced the completion of the first subject dosing in a Phase I clinical study for HBM9378 (SKB378), a next-generation fully human antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe asthma. The study is being conducted in China and marks a significant step in the development of this innovative therapy.
Collaboration and Development
HBM9378 is a co-development project between Harbour BioMed and Kelun-Biotech, with both parties equally sharing global rights to the drug. Under the strategic collaboration and agreement, the two companies will jointly explore more innovative therapies involving monoclonal antibodies and antibody-drug conjugates.
Mechanism and Clinical Focus
HBM9378/SKB378 is a fully human monoclonal antibody (mAb) against TSLP, generated from a two heavy chains and two light chains (H2L2) platform. The drug works by inhibiting the TSLP-mediated signaling pathway through blocking the interaction between TSLP and its receptor. TSLP plays a crucial role in DC cell maturation, T helper 2 (Th2) cell polarization, and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma.
Future Outlook
The initiation of the Phase I clinical study for HBM9378 highlights Harbour BioMed’s commitment to advancing novel treatments for severe asthma. With its innovative mechanism and strategic partnership, the company is well-positioned to address significant unmet needs in the treatment of respiratory diseases.-Fineline Info & Tech