Chime Biologics and Mabgeek have completed the Process Performance Qualification (PPQ) for the humanised anti-IL-4Rα monoclonal antibody, MG-K10, advancing it into Phase III clinical trials for a range of Th2-mediated inflammatory diseases.
The diseases include chronic obstructive pulmonary disease (COPD), moderate-to-severe atopic dermatitis (AD), and asthma.
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Established in 2022, the partnership is centred on the commercial manufacturing of a cGMP 2000L drug substance.
It also encompasses late-stage chemistry, manufacturing, and controls (CMC) development and a biologics licence application (BLA) to expedite the commercialisation of the ‘Best-in-Class biologic’ MG-K10.
Leveraging Mabgeek’s ‘expertise’ in monoclonal antibodies, which is complemented by Chime Biologics’ application of ‘quality-by-design concepts’, CMC processes, and risk management methodology, the collaboration will expedite development timelines while upholding regulatory compliance and worldwide quality standards.
The antibody claims to be the ‘only’ pipeline product of this kind that has been verified in a late clinical trial to be dosed one time every four weeks (Q4W).
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By GlobalDataMabgeek CEO Dr Chenghai Zhang said: “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.
“We will continue to advance this partnership with Chime Biologics to commercial manufacturing, aiming to broaden access to groundbreaking therapies for patients worldwide.”
Phase III trials for MG-K10 are currently in progress. The Phase II clinical outcomes of the antibody have already shown ‘potential’ to be ‘best-in-class’.
In the Phase II trial for moderate-to-severe AD, the antibody significantly improved the quality of life and clinical signs of the individuals. It notably enhanced lung function and clinical symptoms in the Phase II trial for moderate-to-severe asthma, the company noted.
Unlike other anti-IL-4Rα therapeutics that require dosing every two weeks, MG-K10 claims to have demonstrated ‘high efficacy and tolerability’ with a Q4W dosing regimen.
