#Mabwell #CDH17 #7MW4911

Mabwell's Breakthrough ADC 7MW4911: A New Hope in Cancer Treatment

Introduction
In a landmark development for oncology, Mabwell (688062.SH), a cutting-edge biopharmaceutical company, has announced that its self-developed antibody-drug conjugate (ADC), 7MW4911, has secured Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). This pivotal milestone allows the commencement of Phase I/II clinical trials aimed at evaluating the safety, pharmacokinetics, and efficacy of 7MW4911 in patients with advanced colorectal cancer and other severe gastrointestinal tumors.

The Technology Behind 7MW4911
7MW4911 is a breakthrough cancer therapy developed using Mabwell's proprietary IDDC™ platform. This highly sophisticated ADC utilizes a CDH17-targeting monoclonal antibody, Mab0727, known for its rapid internalization capabilities and effective binding properties, ensuring minimal off-target effects. Its innovative structure consists of three critical components:

• - Mab0727: A highly selective CDH17 monoclonal antibody that shows moderate affinity across species, minimizing unwanted binding.
• - Novel Cleavable Linker: This ensures accurate payload release directly within tumor tissues, enhancing therapeutic efficacy.
• - MF-6 Payload: A uniquely designed DNA topoisomerase I inhibitor that combats multidrug resistance (MDR), boasting superior stability in plasma and effective drug release mechanisms.

Clinical Promises
In July 2025, Mabwell unveiled compelling preclinical data published in Cell Reports Medicine, showcasing 7MW4911’s unique ability to target tumors while minimizing systemic toxicity. Some highlighted advantages include:

• - Optimized Molecular Architecture: A homogenous drug-to-antibody ratio (DAR=4, >95%) ensures exceptional stability in plasma, while the MF-6 payload enhances bystand killing efficacy in neighboring cancer cells.
• - Broad Antitumor Activity: Demonstrating significant tumor regression in various cancer models, including those with RAS/BRAF mutations and different Consensus Molecular Subtypes (CMS).
• - Overcoming MDR: The ADC shows impressive performance in models resistant to MMAE/DXd, effectively reversing tumor progression post-treatment.
• - Target Versatility: Active even in tumors with varying CDH17 expression levels, expanding the potential patient demographic for treatment.
• - Favorable Safety Profile: Limited distribution in non-target tissues, manageable pharmacokinetics, and no significant toxicity risks noted in cynomolgus monkeys.

The Significance of CDH17
CDH17 is a validated target across various cancer types, particularly noted for its overexpression in gastrointestinal cancers such as colorectal, gastric, and pancreatic cancers. This strong correlation with tumor metastasis and unfavorable prognosis makes CDH17 an appealing target for therapeutic intervention.

About Mabwell
Mabwell is an innovation-centric biopharmaceutical entity that manages the complete pharmaceutical value chain. Their commitment is to deliver effective and substantially accessible therapeutic options tailored to global health demands, with a focus on oncology and aging-related diseases. Mabwell operates under the mission of