By Fineline Cube 
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its self-developed CDH17-targeted antibody-drug conjugate (ADC), 7MW4911, has received approval from the U.S. Food and Drug Administration (FDA) for Phase 1/2 clinical trials. The trials will evaluate the drug’s efficacy in treating advanced colorectal cancer (CRC) and other advanced gastrointestinal tumors.
Drug Profile
7MW4911 is an innovative ADC developed using Mabwell’s proprietary DDC antibody conjugation technology platform. It integrates three core components:
- A highly specific anti-CDH17 monoclonal antibody (Mab0727) designed for rapid internalization and moderate affinity across species (human/monkey).
- A novel cleavable linker.
- A proprietary DNA topoisomerase I inhibitor payload (MF-6), engineered to overcome multidrug resistance mechanisms.
Mechanism of Action
The MF-6 payload enhances antitumor activity through excellent plasma stability, controlled drug release, and a potent bystander effect. This design ensures targeted delivery and maximizes therapeutic impact while minimizing off-target effects.
Clinical Trial Objectives
The Phase 1/2 clinical trials aim to assess the safety, tolerability, and preliminary efficacy of 7MW4911 in patients with advanced colorectal cancer and other gastrointestinal tumors. The trials will provide critical data to support the drug’s further development and potential regulatory approval.-Fineline Info & Tech