Pharma Focus Asia

Mabwell's Innovative B7-H3 ADC 7MW3711 Receives FDA IND Approval

Wednesday, February 21, 2024

Mabwell (688062.SH), an innovative biopharmaceutical company with a comprehensive industry chain, recently announced the approval of its clinical trial application by the U.S. Food and Drug Administration (FDA) for B7-H3 targeting ADC (R&D code: 7MW3711) designed for advanced malignant solid tumors. The clinical trial for 7MW3711 has also commenced in China.

The next-generation antibody-drug conjugate 7MW3711, developed using Mabwell's proprietary IDDC™ platform, comprises an innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor). Once administered, 7MW3711 selectively binds to antigens on the tumor cell membrane, undergoes internalization, releases cytotoxic drugs, and induces tumor cell apoptosis.

7MW3711 is characterized by its stable structure, homogeneous composition, high purity, and suitability for industrial scale-up. It has demonstrated superior tumor-killing efficacy in various animal tumor models compared to similar drugs domestically and internationally. Animal safety evaluations, including in cynomolgus monkeys, have shown promising safety profiles and pharmacokinetic properties, indicating its clinical differentiation and potential for future development.

B7-H3 is a member of the B7 ligand family, commonly overexpressed in most cancer types while expressed at low levels in normal tissues. It inhibits tumor antigen-specific immune responses and promotes various protumorigenic effects within malignant tissues.

Mabwell has developed multiple ADC technology platforms, including the IDDC™ platform, which integrates core patent technologies to enhance structural homogeneity, quality stability, and pharmacodynamics of ADC products.

The advantages of the IDDC™ platform have been validated across multiple products under development. Mabwell received IND approval for Trop-2 targeting ADC (R&D code: 9MW2921) from the Center for Drug Evaluation (CDE) in China in July 2023, initiating clinical trials for treating advanced solid tumors. Multiple ADC products are expected to advance into clinical development stages in 2024.



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