Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711

Release time:Feb 18, 2024

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of B7-H3 targeting ADC (R&D code: 7MW3711) for advanced malignant solid tumor was approved by the U.S. Food and Drug Administration (FDA). 7MW3711 is developed by Mabwell's next-generation antibody-drug conjugate platform IDDC™. The clinical trial of 7MW3711 has been initiated in China.

The next generation antibody-drug conjugate 7MW3711 with proprietary intellectual property right is composed of innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor). 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, 7MW3711 shows good safety profile and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.

About B7-H3

B7-H3 is a member of the B7 ligand family and is overexpressed in most cancer types but expressed at a low level in normal tissues. In malignant tissues, B7-H3 inhibits tumor antigen-specific immune responses, resulting in a protumorigenic effect. Additionally, B7-H3 promotes migration and invasion, angiogenesis, chemotherapy resistance, endothelial-to-mesenchymal transition, and affects tumor cell metabolism.

About next generation antibody-drug conjugate platform IDDC™

Mabwell has developed multiple ADC technology platforms. Phase III clinical study of novel Nectin-4-targeting ADC (R&D code: 9MW2821) for the treatment of urothelial carcinoma is ongoing.

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 multiple products under development. Mabwell received IND approval of Trop-2 targeting ADC (R&D code: 9MW2921) from Center for Drug Evaluation (CDE) in China in July, 2023, and initiated the clinical trial for the treatment of advanced solid tumor. It is expected that multiple ADC products will be in the stage of clinical development in 2024.