#China #Shanghai #ADC #Mabwell #CDH17

Mabwell's Breakthrough: The Launch of 7MW4911

Mabwell Biopharmaceuticals has marked a significant milestone in cancer treatment with the recent IND clearance from the National Medical Products Administration (NMPA) in China for its CDH17-targeting antibody-drug conjugate (ADC), known as 7MW4911. This groundbreaking therapy is designed to address advanced solid tumors, specifically in gastrointestinal cancers, a field of intense research and development given the rising incidence of these conditions globally.

The innovative structure of 7MW4911 is built upon Mabwell's proprietary IDDC™ platform, featuring a strategic combination of three critical components:

1. Mab0727: A highly specific monoclonal antibody targeting CDH17, known for its rapid internalization properties. This antibody shows promising moderate cross-species affinity with minimal off-target interactions, ensuring that the drug precisely targets cancer cells while sparing healthy tissue.

2. Novel Cleavable Linker: This intelligent design allows for the precise release of the therapeutic payload directly within the tumor tissue, enhancing the efficacy of the treatment.

3. MF-6 Payload: This proprietary DNA topoisomerase I inhibitor showcases the potential to combat multidrug resistance (MDR), a significant hurdle in oncological treatments. MF-6 is engineered for exceptional plasma stability, controlled drug release, and the ability to exert potent effects on adjacent tumor cells, thus maximizing its therapeutic potential.

In July 2025, Mabwell released pivotal preclinical data in Cell Reports Medicine, where the studies indicated that 7MW4911 demonstrated tumor-selective cytotoxicity thanks to CDH17-mediated internalization. Noteworthy advantages from this ADC include:

• - Optimized Molecular Design: With a homogeneous drug-to-antibody ratio exceeding 95%, 7MW4911 exhibits outstanding stability in plasma, maximized by the membrane-permeable nature of the MF-6 payload, which drives effective bystander killing.
• - Broad Antitumor Efficacy: The ADC has shown tremendous potential in preclinical models, demonstrating tumor regression in colorectal, gastric, and pancreatic cancer models that present RAS/BRAF mutations or belong to various Consensus Molecular Subtypes.
• - MDR Resistance: 7MW4911 has outperformed established ADCs, such as those based on MMAE and DXd, in models resistant to ABC transporter-mediated resistance. Importantly, it has shown to reverse tumor progression even after previous ADC treatment.
• - Target Versatility: Its efficacy is evident even in tumors where CDH17 expression is low to moderate, thereby broadening the eligibility criteria for patients seeking treatment.
• - Favorable Safety Profile: Initial studies in mice indicated limited distribution in healthy tissues and controllable pharmacokinetics, with no significant toxicity signals observed in cynomolgus monkeys.

As it stands, 7MW4911 is positioned as a promising candidate for patients suffering from advanced gastrointestinal cancers. Furthermore, the ADC has received approval from the FDA for clinical trials in the U.S., looking to initiate studies on advanced colorectal cancer and other related conditions.

Understanding CDH17

CDH17 (cadherin-17) is currently recognized as a pan-cancer validated target due to its specific overexpression in various gastrointestinal cancers compared to minimal expression in normal intestinal tissues. This aberrant activity correlates strongly with tumor metastasis and poor prognosis, making CDH17 a prime candidate for therapeutic intervention.

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company committed to delivering advanced therapies that meet global health needs across the spectrum of oncological and age-related diseases. With a mission to "Explore Life, Benefit Health," and a vision to transform innovation from concept to reality, Mabwell is dedicated to making a significant impact in the healthcare landscape. For additional insights, visit Mabwell's website.

Conclusion

Mabwell's 7MW4911 is ushering in a new era of cancer treatment, potentially offering hope to many patients through its innovative design and focused therapeutic targeting capabilities. As clinical studies progress, the potential for this therapeutic to reshape the landscape of gastrointestinal cancer treatment grows ever more tangible.