Mabgeek, with support from Chime Biologics, is advancing its novel monoclonal antibody, MG-K10, into Phase III clinical trials following the successful completion of Process Performance Qualification (PPQ). This milestone marks a significant step forward in the development of a potential best-in-class therapy for Th2-mediated inflammatory diseases.
MG-K10, a humanized anti-IL-4Rα monoclonal antibody, is designed to treat a range of conditions, including moderate-to-severe atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), rhinosinusitis, prurigo nodularis, and esophagitis. These diseases are characterized by inflammation driven by the Th2 immune pathway, making IL-4Rα a key target for therapeutic intervention.
The collaboration between Chime Biologics, a global contract development and manufacturing organization (CDMO), and Mabgeek, a clinical-stage biotech company, was established in 2022. It focuses on accelerating the commercial manufacturing and development of MG-K10. This includes cGMP 2000L drug substance production, late-stage chemistry, manufacturing, and controls (CMC) development, and biologics license application (BLA) processes.
Dosing and Efficacy
MG-K10 is distinguished by its potential for once-every-four-week (Q4W) dosing, a feature verified in late-stage clinical studies. This less frequent dosing schedule could improve patient adherence compared to other anti-IL-4Rα therapeutics that require dosing every two weeks (Q2W). Phase II clinical results of MG-K10 in both AD and asthma confirmed its potential to be a best-in-class treatment. In a Phase II trial for moderate-to-severe AD, MG-K10 significantly improved patients' clinical signs and quality of life. Similarly, in a Phase II trial for moderate-to-severe asthma, MG-K10 significantly improved lung function and clinical symptoms.
Expert Commentary
Dr. Chenghai Zhang, CEO of Mabgeek, stated, "The successful PPQ for our pioneering MG-K10 antibody is a testament to the power of collaboration between us, and we are confident in entering the American and European markets, leveraging our strong innovation capabilities and commitment to meeting unmet clinical needs in allergic inflammatory diseases and autoimmune diseases."
Dr. Jimmy Wei, President of Chime Biologics, commented, "We are delighted with the successful completion of MG-K10’s PPQ. This achievement marks a significant milestone in our partnership and signals its immense potential in the global market."
Strategic Implications
The advancement of MG-K10 into Phase III trials underscores the commitment of Chime Biologics and Mabgeek to delivering innovative biologic treatments to address unmet clinical needs in immuno-inflammatory conditions. The strategic focus on the American and European markets reflects the potential for MG-K10 to compete with existing therapies and capture significant market share.
With Phase III trials underway, the collaboration aims to demonstrate the efficacy and safety of MG-K10 in larger patient populations, paving the way for regulatory approval and commercialization.
