Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the first patient has been dosed in the Phase I/II clinical trial of its independently developed novel CDH17-targeting antibody-drug conjugate (ADC) (R&D code: 7MW4911) for advanced solid tumors.

This Phase I/II clinical trial (CTR20254163) aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of 7MW4911 in patients with advanced solid tumors. Previously, 7MW4911 had received IND clearance from FDA to initiate a Phase I/II clinical trial for advanced colorectal cancer and other advanced gastrointestinal tumors (NCT07216560).

7MW4911 is a novel CDH17-targeting ADC developed by Mabwell based on its proprietary IDDC™ platform. It is composed of a highly specific CDH17 monoclonal antibody capable of efficient internalization into tumor cells, a novel cleavable linker with high plasma stability, and a proprietary DNA topoisomerase I inhibitor payload, MF-6, specifically designed to overcome the multidrug resistance.

Preclinical studies demonstrated that 7MW4911 exhibited potent antitumor activity in CDX/PDX models of various gastrointestinal tumors. In multidrug-resistant models, its antitumor effect was significantly superior to MMAE/DXd-based ADCs, and it was able to reverse tumor progression following treatment with such ADCs, highlighting its advantage in treating resistant tumors.