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Mabwell's CDH17-targeting ADC 7MW4911 Receives IND Clearance from FDA
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the U.S. Food and Drug Administration (FDA). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.
About this update from Mabwell (shanghai) Bioscience Co., Ltd. Class A
[{"type":"text","content":"SHANGHAI, Aug. 19, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the U.S. Food and Drug Administration (FDA). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.","length":490,"tagName":"p"},{"type":"text","content":"7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell's proprietary IDDC™ platform. Its highly optimized structure integrates three key elements:","length":169,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.","length":171,"tagName":"p"}]},{"val":[{"type":"text","content":"Novel cleavable linker: Ensures precise payload release in tumor tissues.","length":73,"tagName":"p"}]},{"val":[{"type":"text","content":"MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.","length":204,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":448,"olType":false},{"type":"text","content":"In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911's tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:","length":340,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Optimized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.","length":197,"tagName":"p"}]},{"val":[{"type":"text","content":"Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and...
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