SHANGHAI, July 26, 2023 /PRNewswire/ -- 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.
Oral Presentation
Abstract Title:
Preliminary results from a phase I/II study of 9MW2821, an antibody-drug conjugate targeting Nectin-4, in patients with advanced solid tumors
Abstract Number:
4613
Poster Presentation
Abstract Title:
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
Abstract Number:
3602
About 9MW2821
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).
About 8MW0511
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.
About Mabwell
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, 3 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.
Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms.
Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to:environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results.
The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.
