Mabwell announced the data and latest progress of the Phase I/II clinical study of 9MW2821, a novel Nectin-4-targeting ADCs for multiple advanced solid tumors, which will be reported as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. As of April 1, 2024, among 240 patients in the 1.25 mg/kg dose group in the Phase II clinical trial: Urothelial Carcinoma (UC) Of the 37 patients evaluable for efficacy assessment, the objective response rate (ORR) and disease control rate (DCR) were 62.2% and 91.9%, respectively, with median progression-free survival (mPFS) was 8.8 months and median overall survival (mOS) was 14.2 months. Cervical Cancer (CC) Of the 53 patients evaluable for efficacy assessments, 51% were previously treated with platinum-based doublet chemotherapy and bevacizumab, and 58% received platinum-based doublet chemotherapy, with ORR and DCR were 35.8% and 81.1%, respectively.

The mPFS was 3.9 months, with mOS not reached. Safety Profile: To date, the most common treatment-related adverse events (all grade, grade 3) in the 240 patients in the 1. 25 mg/kg dose group were white blood cell count decreased (50.8%, 23.3%), neutrophil count decreased (46.3%, 27.9%), anemia (43.8%, 8.3%), aspartate aminotransferase increased (42.1%, 2.9%), alanine aminotransferase increase (35.4%, 2.1%), asthenia (32.1%, 2.9%, 5.0%), decreased appetite (28.8%, 1.3%), nausea (26.7%, 0%), hyperglycemia (25.4%, 2.1%, 2.1%), platelet count decreased (24.2%, 4.6%), alopecia (24.2%, 0%), hypoaesthesia (22.5%, 1.7%), constipation (21.3%, 0%), vomiting (20.9%, 1.3%), hypertriglyceridemia (20.4), 2.1%), and gamma glutamyl aminotransferase increases (15.8%, 5.4%). The data suggest that 9MW2821 has a manageable safety profile.

About 9MW2821: 9MW2821 is the first site-specific conjugated novel Nectin-4 -targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4- targeting ADCs developed by Chinese companies, and the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer, esophageal cancer and breast cancer. 9MW2821 has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer in Feb. 2024 and May 2024, respectively.

9MW2821 achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials.

The company have also undertaken 1 national major scientific and technological special project for "Sign Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in the Taizhou factory possesses robust In-house manufacturing capability compliant with international GMP standards regulated by the NMPA, and EMA, and technological innovation projects. MABP standards regulated by the NM PA, and EMA, and EMA, 3 products.1, and technological special project.Mab and has passed the NMPA, and has passed the EU QP standards regulated by the EU QP Audit.1.2.