SHANGHAI, Oct. 23, 2023 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces the latest clinical progress of 2 novel drugs including Nectin-4 ADC 9MW2821, as well as the clinical study data to be reported on ESMO 2023.
Latest progress & phase I/II study data to report on ESMO 2023 of 9MW2821
Up to now, 195 patients with advanced solid tumor have been enrolled in the phase I/II study of Nectin-4 ADC 9MW2821. Among 115 patients with solid tumor treated with 9MW2821 at 1.25mg/kg or above and evaluable for tumor assessment, objective response rate (ORR) and disease control rate (DCR) was 43.5% and 81.7%, respectively. In 37 patients with UC who experienced platinum-based chemotherapy and immune checkpoint inhibitors, dosed at 1.25mg/kg and were evaluable for tumor assessment, ORR and DCR was 62.2% and 91.9%, respectively.
Core data reported on ESMO from phase I/II study of 9MW2821 showed that among 39 subjects with solid tumor who treated with 9MW2821 at 1.25mg/kg or above and evaluable for tumor assessment, ORR and DCR was 38.5% and 84.6%, respectively. In 18 patients with UC who dosed at 1.25mg/kg and evaluable for tumor assessment, ORR and DCR was 55.6% and 94.4%, respectively. All UC patients have been treated with platinum-based chemotherapy and immune checkpoint inhibitors before enrollment.
The results showed that 9MW2821 had manageable safety profile. Treatment related death was not observed. Objective responses were also observed in patients with breast cancer and cervical cancer. Enrollment continues to determine efficacy of 9MW2821 in certain solid tumors.
Proactive communication on pivotal trial of 9MW2821 is ongoing.
Latest progress & phase III study data to report on ESMO 2023 of 8MW0511
Up to now, Mabwell is in the preparation of New Drug Application submission of 8MW0511 within the year.
Core data from phase III study of recombinant (yeast-secreted) human granulocyte-colony stimulation factor fusion protein 8MW0511 for injection, reported at ESMO, showed that 8MW0511 was clinically effective, non-inferior to the positive control. It is able to improve the incidence and duration of grade 4 neutropenia, with a significantly lower incidence and duration of grade 4 neutropenia observed at cycle 2-3 than in the positive control group. The overall safety profile is similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans.
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. Multiple clinical studies of 9MW2821 is ongoing to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with different types of advanced solid tumors.
8MW0511 is a recombinant (yeast-secreted) human granulocyte-colony stimulation factor fusion protein, belonging to Category 1 Therapeutic Biological Products. It is indicated for use in adult patients with non-myeloid malignancies to reduce the incidence of infections manifested by febrile neutropenia when treated with myelosuppressive anticancer drugs that predispose to febrile neutropenia.
Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 1 product has been filed for MA approval, 1 product is in the preparation of filing, 2 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell’s Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com.
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