Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that the first patient dosed in the Phase I/II studies for Trop-2 targeting ADC (R&D code: 9MW2921) and B7-H3 targeting ADC (R&D code: 7MW3711), respectively.

The primary objective of Phase I/II study of 9MW2921 (Register No.: CTR20232341) is to investigate the safety and tolerability, explore the maximum tolerated dose (MTD), confirm the RP2D, and preliminarily evaluate the efficacy of 7MW3711 in particular tumor types.

The primary objective of phase I/II study of 7MW3711 (Register No.: CTR20232441) is to investigate the safety, tolerability, MTD and/or RP2D, and preliminarily evaluate the efficacy of 7MW3711 in particular tumor types.

Trop-2 targeting ADC (9MW2921)

9MW2921 is a next generation antibody-drug conjugate (ADC) developed by Mabwell based on IDDC™ 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 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 safety profile and pharmacokinetic properties.

B7-H3 targeting ADC (7MW3711)

The next generation antibody-drug conjugate molecule 7MW3711 with proprietary intellectual property right, developed by Mabwell's next-generation antibody-drug conjugate platform IDDC™, is composed of innovative antibody molecule, novel linker, and novel payload (TOP1i). When 7MW3711 enters human body, it specifically binds to antigens on the tumor cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells.

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with drugs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good safety profile and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.

Next generation antibody-drug conjugate platform IDDC™

Mabwell has developed multiple ADC technology platforms, and its Nectin-4-targeting ADC (R&D code: 9MW2821) is currently in the phase II study.

IDDC™ is a next 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™, which improves structural homogeneity, quality stability, pharmacodynamics and tolerability of the ADC products.

Currently, the advantage of the IDDC™ platform has been validated in several products under development. Trop-2-targeting ADC (R&D code: 9MW2921) has been approved for clinical study in advanced solid tumor. It is expected multiple ADC products will enter clinical development in 2023 and 2024.