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FDA Greenlights Mabwell's Innovative B7-H3 ADC 7MW3711 for Clinical Trials

Mabwell, an innovative biopharmaceutical company boasting a comprehensive industry chain, has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application of a novel B7-H3 targeting ADC, known as 7MW3711. This ADC, developed through Mabwell's next-generation antibody-drug conjugate platform, IDDC™, has commenced clinical trials in China.

7MW3711 features a proprietary intellectual property composition, including an inventive antibody molecule, a novel linker, and a potent payload (topoisomerase I inhibitor). Upon administration, 7MW3711 selectively binds to tumor cell membrane antigens, internalizes, and releases cytotoxic drugs within lysosomes, inducing tumor cell apoptosis. Notably, 7MW3711 demonstrates superior tumor-killing efficacy and a favorable safety profile in preclinical studies, underscoring its potential for clinical differentiation.

B7-H3, a crucial member of the B7 ligand family, exhibits overexpression in various cancer types while maintaining low expression in normal tissues. Its involvement in inhibiting tumor antigen-specific immune responses contributes to a pro-tumorigenic environment, impacting migration, invasion, angiogenesis, chemotherapy resistance, and tumor cell metabolism.

Mabwell's IDDC™ platform, characterized by core patent technologies such as DARfinity™ for site-specific conjugation, IDconnect™ for linker design, Mtoxin™ for payload innovation, and LysOnly™ for conditional release structures, enhances the structural uniformity, quality stability, pharmacodynamics, and tolerability of ADC products.

Furthermore, Mabwell's IDDC™ platform demonstrates efficacy in multiple products under development, including a Phase III clinical study exploring a novel Nectin-4-targeting ADC (R&D code: 9MW2821) for Urothelial Carcinoma treatment.

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