Mabwell’s CDH17-Targeting ADC 7MW4911 Receives IND Clearance from NMPA
Wednesday, October 15, 2025
Mabwell has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) in China for its CDH17-targeting antibody-drug conjugate (ADC), 7MW4911.
CDH17 is recognised as a promising pan-cancer target, normally expressed in intestinal epithelial tissue but significantly overexpressed in gastrointestinal malignancies such as colorectal, gastric, and pancreatic cancers. Its abnormal expression is associated with metastasis and poor clinical outcomes, making it a valuable target for therapeutic development.
This approval allows the company to begin clinical studies in patients with advanced solid tumours.
Developed using Mabwell’s proprietary IDDC™ platform, 7MW4911 combines three core components:
Mab0727, a highly specific CDH17 monoclonal antibody that internalises rapidly and demonstrates moderate affinity across species with minimal off-target activity.
A novel cleavable linker, designed to ensure precise release of the drug payload in tumour tissues.
MF-6, a proprietary DNA topoisomerase I inhibitor intended to overcome multidrug resistance (MDR), offering strong plasma stability, controlled release, and potent bystander effects.
Preclinical findings published in Cell Reports Medicine in July 2025 showed that 7MW4911 delivers tumour-selective cytotoxicity through CDH17-mediated internalisation. The ADC demonstrated several advantages, including:
- Optimised design: A homogeneous drug-to-antibody ratio (DAR=4, >95%) and a stable linker contribute to high plasma stability, while the membrane-permeable MF-6 payload supports effective bystander killing.
- Broad antitumour activity: The candidate achieved strong tumour regression in colorectal, gastric, and pancreatic cancer models, including those with RAS/BRAF mutations and diverse molecular subtypes.
- Overcoming drug resistance: 7MW4911 showed superior performance to MMAE- and DXd-based ADCs in models with ABC transporter-mediated MDR and was effective in reversing tumour growth following prior ADC treatment.
- Target versatility: The therapy remained active in tumours with low to moderate CDH17 expression, potentially extending its clinical applicability.
- Favourable safety profile: Studies indicated limited tissue distribution, manageable pharmacokinetics, and a wide therapeutic window, with no significant toxicity observed in animal models.
With its distinct mechanism and encouraging preclinical results, 7MW4911 is positioned as a potential treatment for advanced gastrointestinal cancers. The candidate has also obtained IND clearance from the U.S. Food and Drug Administration (FDA) for clinical evaluation in advanced colorectal and other gastrointestinal tumours.
Source: mabwell.com
