China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced preliminary clinical data for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data demonstrated positive therapeutic signals in multiple solid tumors and exhibited a good safety profile at the recommended Phase II dosage (RP2D).
Mechanism of Action and Pharmaceutical Characteristics of 9MW2821
9MW2821 enters tumor cells and binds to Nectin-4 on the surface, releasing cytotoxins in a targeted manner to precisely kill tumors. The drug achieves site-specific modification of antibodies through its proprietary coupling technology linker and an optimized ADC coupling process. This results in uniform components, high purity, and ease of industrialization, making it a promising candidate for cancer treatment.
Non-Clinical Studies and Therapeutic Effects
Non-clinical studies have shown that 9MW2821 has significant tumor suppressive effects in multiple tumor models and exhibits a favorable therapeutic window in animal model-based safety studies.
Clinical Assessment and Preliminary Efficacy
9MW2821 is currently being assessed for safety, tolerability, pharmacokinetics, and preliminary efficacy in a dozen advanced solid tumors. Preliminary data revealed that under RP2D, the objective response rate (ORR) reached 50% and the disease control rate (DCR) reached 100% in 12 urothelium cancer (UC) subjects. Among six cervical cancer subjects, the ORR and DCR were 50% and 100%, respectively. Mabwell is advancing multiple cohort expansion enrollment for the drug in UC, cervical cancer, prostate cancer, HER2-negative breast cancer, non-small cell lung cancer, and other indications.-Fineline Info & Tech
