TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

Mabwell's Innovative Trop-2 ADC (9MW2921) Obtains NMPA Approval for IND

Wednesday, July 19, 2023

Mabwell, a pioneering biopharmaceutical company with an integrated industry chain, has revealed that the National Medical Products Administration (NMPA) has granted approval for its clinical trial application of 9MW2921, aimed at treating advanced solid tumors. This groundbreaking therapy, 9MW2921, is developed using Mabwell's proprietary antibody-drug conjugate platform known as IDDC™.

The next generation antibody-drug conjugate (ADC), 9MW2921, has been specifically designed by Mabwell to combat solid tumors. The ADC comprises an innovative antibody molecule that is connected to a novel payload (TOP1i) through a unique linker, all of which are fully protected by Mabwell's intellectual property rights. Once inside the body, 9MW2921 precisely targets antigens on the surface of cell membranes, leading to internalization and transportation to lysosomes, where a cytotoxic drug is released, ultimately inducing tumor cell apoptosis.

The pharmaceutical characteristics of 9MW2921, including its stable structure, homogeneous composition, and high purity, make it suitable for large-scale production. In comparison to other ADCs currently in development, 9MW2921 exhibits substantial improvements in endocytic activity, plasma stability, drug release characteristics, and bystander killing effects. Preclinical studies have demonstrated superior tumor-killing activity. Moreover, safety evaluations in animal models, including cynomolgus monkeys and rats, have shown that 9MW2921 effectively controls both on-target and off-target toxicities, indicating its favorable safety profile and pharmacokinetic properties.

Trop-2, a member of the TACSTD family, is a cell surface glycoprotein encoded by the TACSTD gene. While it is expressed at low levels in normal tissues, it becomes overexpressed in various malignant tumors, correlating with tumor aggressiveness. Trop-2 overexpression is associated with tumor cell growth, proliferation, and metastasis.

Mabwell has developed multiple ADC technology platforms, with their anti-Nectin-4 ADC (R&D code: 9MW2821) currently in phase II clinical trials. Among these platforms, IDDC™ stands out as a next-generation ADC site-specific conjugate technology. It incorporates core patent technologies, such as the site-specific conjugate process DARfinity™, the specially designed linker IDconnect™, the novel payload Mtoxin™, and the conditional release structure LysOnly™.

The systematic application of patent technologies through IDDC™ ensures improved structural homogeneity, quality stability, pharmacodynamics, and tolerability. Mabwell anticipates validating this platform in several products under development, with multiple ADC products expected to enter clinical trials in 2023 and 2024.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit