HOXB7

SHANGHAI, Feb. 20, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of B7-H3 targeting ADC (R&D code: 7MW3711) for advanced malignant solid tumor was approved by the U.S. Food and Drug Administration (FDA). 7MW3711 is developed by Mabwell's next-generation antibody-drug conjugate platform IDDC™. The clinical trial of 7MW3711 has been initiated in China. The next generation antibody-drug conjugate 7MW3711 with proprietary intellectual property right is composed of innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor). When 7MW3711 enters human body, it specifically binds to antigens on the tumor cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells. 7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with drugs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, 7MW3711 shows good safety profile and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development. About B7-H3 B7-H3 is a member of the B7 ligand family and is overexpressed in most cancer types but expressed at a low level in normal tissues. In malignant tissues, B7-H3 inhibits tumor antigen-specific immune responses, resulting in a protumorigenic effect. Additionally, B7-H3 promotes migration and invasion, angiogenesis, chemotherapy resistance, endothelial-to-mesenchymal transition, and affects tumor cell metabolism. About next generation antibody-drug conjugate platform IDDC™ Mabwell has developed multiple ADC technology platforms. Phase III clinical study of novel Nectin-4-targeting ADC (R&D code: 9MW2821) for the treatment of Urothelial Carcinoma is ongoing. IDDC™ is a next generation ADC site-specific conjugate technology platform independently developed by Mabwell. It is composed of multiple systematized core patent technologies including site-specific conjugate process DARfinity™, special designed linker IDconnect™, novel payload Mtoxin™, and conditional release structure LysOnly™, which improves structural homogeneity, quality stability, pharmacodynamics and tolerability of the ADC products. Currently, the advantage of the IDDC™ platform has been validated in multiple products under development. Mabwell received IND approval of Trop-2 targeting ADC (R&D code: 9MW2921) from Center for Drug Evaluation (CDE) in China in July, 2023, and initiated the clinical trial for the treatment of advanced solid tumor. It is expected that multiple ADC products will be in the stage of clinical development in 2024. 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, 2 products have 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 . 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

Ivan Cheung has been named the new chief executive at NextPoint Therapeutics, a clinical-stage biotech developing cancer therapies. He joins NextPoint from Eisai, where he most recently served as CEO of their US business before stepping down last July.Cheung takes over from founding CEO Detlev Biniszkiewicz of MPM BioImpact, who oversaw NextPoint's transition from a preclinical biotech in 2018 to clinical-stage company after a pair of financing rounds, including an $80-million Series B last year co-led by the investment arms of Bayer and Sanofi.Biniszkiewicz, who will stay on as chairman of the board, says the incoming CEO's "proven leadership, deep industry expertise and commitment to scientific innovation make him the ideal person to shepherd the company into this exciting next chapter."During his tenure at Eisai, Cheung guided the Japanese drugmaker's North America business to over $1.5 billion in revenue. He was also a key player in the development and launch of products such as the targeted cancer therapy Lenvima (lenvatinib), and oversaw last year's full US approval of Eisai's Biogen-partnered treatment Leqembi (lecanemab) for Alzheimer's disease.Meanwhile, NextPoint is developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway. In December, the company was given a green light by the FDA to begin a first-in-human Phase I study of its NPX887 candidate early this year in patients with solid tumours known to express the antigen, a member of the B7 receptor family.According to the company, a key point is that HHLA2 is independent of PD-L1 and is often most strongly expressed in PD-L1-negative cancers. NextPoint's approach works by re-activating T and NK cell activity in tumours that are suppressed by HHLA2-driven immune evasion.