#China #Shanghai #Mabwell #CDH17 #7MW4911

Mabwell's Innovative Acquisition in Cancer Treatment

Mabwell, an innovative biopharmaceutical firm based in Shanghai, has recently announced the acceptance of their Investigational New Drug (IND) application for their proprietary anticancer agent, 7MW4911, by both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA). This dual acceptance signals a notable milestone for the company, promising advancements in targeted cancer therapies.

Insight into 7MW4911

7MW4911 is a groundbreaking antibody-drug conjugate (ADC) that specifically targets CDH17, a protein prominently overexpressed in several gastrointestinal cancers, such as colorectal, gastric, and pancreatic cancers. The ADC has been developed utilizing Mabwell's cutting-edge IDDC™ platform, which optimizes the efficacy and stability of the drug.

Key Features of 7MW4911

1. Monoclonal Antibody: The backbone of 7MW4911 is Mab0727, a highly selective monoclonal antibody that displays rapid internalization and moderate affinity across species, minimizing off-target effects.
2. Smart Linkage: The ADC employs a novel cleavable linker which ensures precise delivery and release of the drug directly into tumor tissues, enhancing its therapeutic potential.
3. Unique Payload: Incorporating MF-6, a proprietary DNA topoisomerase I inhibitor, it is designed to effectively tackle multidrug resistance (MDR). This component showcases superior stability in plasma, controlled drug release, and effective killing of surrounding cancerous cells.

Preclinical Success

Recent preclinical studies published in Cell Reports Medicine have demonstrated the robust efficacy of 7MW4911 against tumors with CDH17 expression. Specifically, key findings include:

• - Optimized Molecular Design: With an exceptional drug-to-antibody ratio (DAR=4, >95%), 7MW4911 is managed to achieve remarkable plasma stability, contributing to its overall performance.
• - Diverse Antitumor Efficacy: 7MW4911 has shown impressive results in tumor regression across various models, including those with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS).
• - MDR Counteraction: The drug substantially outperformed other ADCs in alleviating drug resistance, indicating its potential as a superior option in clinical settings.
• - Safety Profile: Preclinical trials revealed limited distribution in healthy tissues, a manageable pharmacokinetic profile, and no significant toxicity in cynomolgus monkeys, indicating high safety.

CDH17: A Target of Interest

The CDH17 protein is not only pivotal in gastrointestinal cancer therapy but also represents a potential pan-cancer target due to its limited normal tissue expression and significant correlation with poor prognoses in malignancies. Its unique characteristics make it an optimal candidate for targeted therapeutic approaches.

About Mabwell

Founded with a mission to provide accessible and effective therapies, Mabwell operates across the entire pharmaceutical development spectrum. The company is deeply committed to addressing global health challenges, particularly in oncology and age-related diseases. With the driving vision of turning innovative ideas into reality, Mabwell is on an ambitious journey that resonates with its motto, "Explore Life, Benefit Health."

Looking Ahead

The acceptance of the IND application for 7MW4911 marks a crucial advancement for Mabwell, holding promise not only for the company but also for patients suffering from advanced gastrointestinal cancers. As the company proceeds to the clinical phases, there is hope that 7MW4911 could soon become a vital tool in the oncology arsenal, paving the way for future innovative therapies in the fight against cancer.