Mabwell, an innovative biopharmaceutical company with an entire industry chain, has announced that the first patient has been dosed in a phase Ib/II trial of its novel Nectin-4 targeting ADC (R&D code: 9MW2821) in combination with a PD-1 inhibitor for the treatment of locally advanced or metastatic urothelial carcinoma.

The clinical trial, coded as CTR20232677, aims to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetic profile of 9MW2821 in combination with a PD-1 inhibitor in patients with locally advanced or metastatic urothelial carcinoma.

About 9MW2821:

9MW2821 is a novel Nectin-4 targeting ADC developed by Mabwell, utilizing a world-class ADC development platform and an automated high-throughput antibody discovery platform. This ADC achieves site-specific modification of antibodies through proprietary conjugate technology linkers and an optimized ADC conjugation process. 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized, release cytotoxic drugs, and induce the apoptosis of tumor cells.

9MW2821 offers advantages such as homogeneous composition, higher purity, and suitability for industrial scale-up. Preliminary data indicate positive therapeutic signals in solid tumors and a good safety profile at the recommended phase II dose (RP2D). Mabwell is actively enrolling multiple cohorts for urothelial carcinoma (UC), cervical cancer (CC), prostate cancer, HER-2 negative breast cancer, and non-small cell lung cancer. The R&D progress of 9MW2821 ranks first in China and second in the world. Notably, 9MW2821 is the first to receive preliminary clinical data in cervical cancer among drug candidates with the same target globally. Phase data will be presented at the ESMO Congress 2023.