Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been approved by the NMPA to enter Phase II clinical trial as monotherapy or in combination with a PD-1 inhibitor for the treatment of triple-negative breast cancer (TNBC).

The Phase II clinical trial recently approved aims to evaluate the efficacy and safety of 9MW2821 as monotherapy or in combination with a PD-1 inhibitor in patients with locally advanced or metastatic TNBC. The study includes two cohorts: Cohort A will enroll patients with locally advanced or metastatic TNBC who have previously received taxane/anthracycline-based chemotherapy and topoisomerase inhibitor based antibody-drug conjugate treatment, and will receive 9MW2821 monotherapy; Cohort B will enroll patients with locally advanced or metastatic TNBC who have not previously received systemic therapy, and will receive a combination treatment of 9MW2821 and a PD-1 inhibitor. 

Clinical results previously presented at the 2024 ASCO Annual Meeting showed that among the 20 patients with locally advanced or metastatic TNBC treated by 9MW2821 and evaluable for efficacy assessment, the objective response rate (ORR) and disease control rate (DCR) were 50.0% and 80.0% respectively. The median progression-free survival (mPFS) was 5.9 months, and the median overall survival (mOS) was not yet reached, with one patient achieved complete response (CR) and had been in CR for 20 months and is currently sustained to be CR. Additionally, 9MW2821 has recently been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive TNBC.

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 (CC), esophageal cancer (EC) and breast cancer. 9MW2821 has been granted FTD by FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in Feb. 2024, and also respectively granted Orphan Drug Designation (ODD) and FTD for the treatment of EC and recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen in May 2024. Then, it has been granted FTD for the treatment of locally advanced or metastatic Nectin-4 positive TNBC in July, 2024.

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.