Accelerating Development of Mabwell's ADC Plateform: Clinical Trial Application for an Innovative Drug (9MW2921) Accepted by NMPA

Release time:Feb 05, 2023

Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that its IND application of 9MW2921 for solid tumor was accepted by the National Medical Products Administration (NMPA). 9MW2921 is developed through Mabwell's novel Antibody Drug Conjugate platform IDDC™.

9MW2921 is a next generation Antibody-Drug Conjugate (ADC) developed by Mabwell based on IDDC™ (Interchain-Disulfide Drug Conjugate) platform for the treatment of solid tumors. It is an innovative antibody molecule linked to a novel payload (TOP1i) by a novel linker with fully autonomous intellectual property right. When 9MW2921 enters into the body, it can specifically bind to antigens on the cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug and induce the apoptosis of tumor cells.

9MW2921 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs of the same class under development at home and abroad, 9MW2921 is significantly improved and optimized in endocytic activity, plasma stability, drug release characteristics, bystander killing effect, etc. In vivo pharmacodynamic studies demonstrated that 9MW2921 had a better tumor killing activity. In animal safety evaluation models including cynomolgus monkeys and rats, the on-target and off-target toxicities of 9MW2921 were effectively controlled, indicating that 9MW2921 has good drug safety and pharmacokinetic properties.

IDDC™ is a new generation ADC site-specific conjugate technology platform independently developed by Mabwell. It is composed of multiple systematized core patent technologies including site-specific conjugate process DARfinity™, special designed linker IDconnect™, novel payload Mtoxin™, and conditional release structure LysOnly™.

The next generation ADCs developed based on the above systematic patent technologies will carry better structural homogeneity, quality stability, pharmacodynamics and tolerability. Currently, the IDDCTM platform has been validated in several products under development. It is expected that 3 to 5 ADC products will enter clinical development from 2023 to 2024.

Mabwell has developed multiple ADC technology platforms, and its anti-Nectin-4 ADC drug (R&D code: 9MW2821) is currently in the stage of clinical studying.