Recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein(Mabwell (Shanghai) Bioscience Co., Ltd.)

Shanghai, Oct. 25, 2023 /PRNewswire/ -- ESMO Congress 2023 was held in Madrid, Spain from October 20-24, the preliminary results of the Phase I/II study of 9MW2821 (Nectin-4 targeting ADC) in patients with advanced solid tumors were reported by Dr. Jian Zhang of Fudan University Shanghai Cancer Center, on behalf of the research team. The results of the Phase III study of 8MW0511 were presented as a poster. 9MW2821: Oral Presentation Continue Reading Background Nectin-4 is an adhesion molecule that highly expressed in variety of solid tumors including urothelial cancer and could be a potent therapeutic target. 9MW2821 is a monoclonal antibody-drug conjugate (ADC) that delivers monomethyl auristatin E to cells expressing Nectin-4. The study assessed its safety, tolerability and preliminary efficacy in patients with solid tumors. Methods 9MW2821 was administered by intravenous infusion on days 1, 8 and 15 of each 28-day cycle. The study included dose escalation, dose expansion and cohort expansion period which included urothelial cancer (UC) and other Nectin-4 positive solid tumors. Primary objectives were assessment of safety and preliminary efficacy. Results As of April 27, 2023, 97 patients (including 39 UC patients and 29 cervical cancer patients) were enrolled with doses ranging from 0.33 to 1.5mg/kg. Median age was 57 years (range, 32-78). All patients have been treated with platinum-based chemotherapy and immune checkpoint inhibitors before enrollment. Treatment related death was not observed. Only 1 dose limiting toxicity of grade 4 neutropenia lasted more than 5 days was observed at 1.5mg/kg group. Maximum tolerated dose was not yet reached. Treatment related adverse events (TRAEs) of any grade occurred in 64.9% patients. The most common TRAEs were white blood cell (WBC) count decreased (36.1%), neutropenia (35.1%), nausea (22.7%), aspartate aminotransferase increased (22.7%), rash (19.6%), alopecia (19.6%), fatigue (18.6%), decreased appetite (18.6%), anemia (17.5%), vomiting (16.5%), peripheral sensory neuropathy (16.5%). Grade 3/4 TRAEs occurred in 35.1% patients. The most common grade 3/4 TRAEs were WBC count decreased (18.6%) and neutropenia (18.6%). 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. Objective responses were also observed in patients with breast cancer and cervical cancer. Conclusion 9MW2821 showed manageable safety profile. Hematological toxicity, the most common adverse events associated with 9MW2821, were deemed to be manageable, tolerable and reversible. In addition to urothelial cancer, 9MW2821 showed promising antitumor activity in multiple tumor types. Enrollment continues to determine efficacy of 9MW2821 in certain solid tumors. 8MW0511: Poster 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. 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, 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 . 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. SOURCE Mabwell

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 pro similar to that of the positive control group, which indicates manageable safety pro good tolerance in humans. 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. 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. About 8MW0511 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. 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, 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 . 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. View original content: SOURCE Mabwell Company Codes: Shanghai:688062