Biologics

FDA Grants Clinical Trial Approval for Mabwell’s Innovative ADC, 7MW3711, Targeting Advanced Malignant Solid Tumors

Published March. 26. 2024
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Mabwell (688062.SH), an innovative biopharmaceutical company with a complete industry chain, has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application of the B7-H3 targeting Antibody-Drug Conjugate (ADC) known as 7MW3711, designed for advanced malignant solid tumors. Developed using Mabwell’s next-generation antibody-drug conjugate platform IDDC™, 7MW3711’s clinical trial has already commenced in China.

The next-generation antibody-drug conjugate, 7MW3711, possesses proprietary intellectual property rights and comprises an innovative antibody molecule, a novel linker, and a novel payload (topoisomerase I inhibitor). Upon entering the human body, 7MW3711 selectively binds to antigens on the tumor cell membrane, undergoes internalization and trafficking to the lysosome, releases a cytotoxic drug, and triggers apoptosis in tumor cells.

Pharmaceutically characterized by its stable structure, homogeneous composition, and high purity, 7MW3711 is well-suited for industrial scale-up. In comparison to similar drugs domestically and internationally, 7MW3711 has demonstrated superior tumor-killing effects in various animal tumor models. Safety evaluations in animal models, including cynomolgus monkeys, have indicated a favorable safety profile and pharmacokinetic properties for 7MW3711. These research findings underscore the clinical differentiation characteristics and promising future of clinical development for 7MW3711.

 

About Mabwell

Mabwell (688062.SH), an innovation-driven biopharmaceutical company, boasts a comprehensive industrial chain encompassing research and development, manufacturing, and commercialization. The company is dedicated to delivering more effective and accessible therapies, along with innovative medicines, to address global medical needs. Since 2017, Mabwell has established an advanced research and development system that spans target discovery, early discovery, druggability, preclinical and clinical research, as well as manufacturing transformation.

 

Source: https://www.mabwell.com/en/news_info/id-101

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