Release time：Jul 21, 2023
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that clinical trial data from phase I/II study for advanced solid tumor of Nectin-4-targeting ADC (9MW2821), and phase III study of Long-Acting Recombinant Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor (I) Fusion Protein (8MW0511) will be presented orally and as a poster respectively at ESMO Congress 2023, which will be held in Madrid, Spain, from Oct. 20th to 24th, 2023.
ESMO Congress is one of the most influential oncology conferences in the world. Please pay close attention to Mabwell’s reports during ESMO Congress 2023.
Preliminary results from a phase I/II study of 9MW2821, an antibody-drug conjugate targeting Nectin-4, in patients with advanced solid tumors
MW05, a Novel, Long-Acting Recombinant Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor (I) Fusion Protein for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial
Developed by Mabwell’s ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, 9MW2821 is the first clinical stage Nectin-4-targeting ADC developed by Chinese company. The site-specific modification of antibody is based on the coupling technology linker and optimized ADC coupling process with independent intellectual property rights. 9MW2821 received IND clearance from NMPA and FDA on Oct.19th, 2021 and Jul. 28th, 2022, respectively. Clinical trial application of combination therapy has also been approved by NMPA on Apr. 14th, 2023. The multiple ongoing clinical studies to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity of 9MW2821 show positive therapeutic signals in different types of advanced solid tumors and good safety profile at the recommended phase II dose (RP2D).
8MW0511 is a novel, long-acting G-CSF (highly active modified cytokine) with independent intellectual property rights of Mabwell. It is intended to reduce the incidence of infection characterized by febrile neutropenia(FN) in the adult patients with non-myeloid malignant tumors, when they are treated with antitumor therapies that are susceptible to FN. 8MW0511 is produced by fusion of N terminal of modified G-CSF genes with C terminal of human serum albumin(HSA) through gene fusion technology, which can significantly inhibit the G-CSF receptor-mediated clearance pathway, prolong the half-life period, decrease the frequency of administration in clinical use, reduce the suffering of patients, and improve the treatment compliance. Meanwhile, 8MW0511 is produced by yeast-expression system, which brings better homogeneity. It is expected to reduce the cost by avoiding the complex PEG modifications and simplifying production process. The phase III clinical trial of 8MW0511 has been completed, and we are moving forward with the preparations of NDA.