Mabwell Gets IND Approval for Promising CDH17-Targeting Cancer Drug 7MW4911

Mabwell Received a Green Signal for CDH17

Announcement

Manwell, an innovative and leading biopharmaceutical company, the pioneer of the entire industry chain, declared that its proprietary CDH17-focused antibody-drug conjugate (ADC), 7MW4911, has received an acceptance from china’s national medical products administration (NMPA) for investigational new drug (IND) application and a IND acknowledgement letter from the US food and drug administration (FDA).

Potency of the New Drug Application

The 7MW4911 is an investigational CDH17-focused ADC built using mabwell’s proprietary IDDC platform. The three major elements of 7MW4911 feature its novel cleavable linker that promises precision to payload release in tumor tissues and Mab0727, a highly advanced CDH17 monoclonal antibody with the fastest internalization properties, reduced off-target binding, and cross-species moderate affinity (human/monkey). Also, the MF-6 payload is a proprietary DNA topoisomerase 1 inhibitor introduced to minimize multidrug resistance (MDR), potent bystander effects, control drug release, and exhibit superior plasma stability.

Mabwell’s Previous Preclinical Data’s Contribution

The mabwell’s preclinical data in cell reports medicine (overcoming multidrug resistance in gastrointestinal cancers with a CDH17-focused ADC conjugated to a DNA topoisomerase inhibitor) in July 2025 explained 7MW4911’s tumor-selective cytotoxicity through CDH17-mediated internalization. The major advantages include MDR resistance, broad antitumor efficacy, target versatility, improved molecular design, and a favorable safety profile.

The MDR resistance advantage is elevated due to its excellent performance of MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reversed tumor succession post-ADC treatment. The vast antitumor efficacy elaborates unique tumor regression in gastric, pancreatic cancer PDX/CDX, and colorectal models, consisting of tumors with diverse RAS/BRAF and mutations consensus molecular subtypes (CMS). The active even in tumors having low to moderate CDH17 expression and an extension to the potential patient eligibility indicates target versatility. The homogeneous drug-to-antibody ratio (DAR=4,>95%) and balanced linker highlights exceptional plasma stability, while the membrane-permeable MF-6 fuels potential bystander killing.

The protective profile emphasizes a broad therapeutic window in cynomolgus monkeys, controlled pharmacokinetics (moderate half-life, no accumulation), and limited tissue distribution in mice, eliminating the toxicity. With this robust profile, 7MW4911 proved as a reliable therapeutic candidate for advanced gastrointestinal cancers.

The acceptance from the higher authority demonstrates Mabwell’s sincere and consistent efforts for exploratory trials for severe cancer conditions. The green signal is an encouragement towards the development and innovation to accelerate the portfolio of the company. Furthermore, the company awaits the completion of the required trials to move forward with the approval for a new drug designation.