Mabwell’s CDH17-targeting ADC 7MW4911 receives IND clearance from FDA

CAR-T Digest - August 2020

19 August 2025: Mabwell’s CDH17-targeting ADC 7MW4911 receives IND clearance from FDA

Mabwell’s CDH17-targeting ADC 7MW4911 received FDA IND clearance to begin Phase 1/2 trials in advanced colorectal cancer and other gastrointestinal tumors, following prior acceptance by China’s NMPA
Built on the IDDC™ platform, 7MW4911 integrates a CDH17-specific antibody (Mab0727), a novel cleavable linker for precise release, and MF-6, a proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance
Preclinical studies showed robust tumor regression in colorectal, gastric, and pancreatic cancer models, including those with RAS/BRAF mutations and varied molecular subtypes
The drug demonstrated superior efficacy against multidrug resistance, outperforming MMAE- and DXd-based ADCs and retaining activity in tumors with low-to-moderate CDH17 expression
Safety data highlighted plasma stability, controlled pharmacokinetics, limited off-target distribution, and a wide therapeutic window in animal models, supporting its strong potential for clinical development