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Mabwell Updates on Clinical Trial Development of 9MW2821 for Triple-Negative Breast Cancer

Tuesday, May 14, 2024

Mabwell (688062.SH), an innovative biopharmaceutical company with a comprehensive industry chain, has provided updates on the clinical study progress of its groundbreaking ADC (Antibody-Drug Conjugate) targeting Nectin-4 for triple-negative breast cancer.

According to the latest data from ongoing monotherapy trials of their ADC, codenamed 9MW2821, in 20 patients with locally advanced or metastatic triple-negative breast cancer treated with a dose of 1.25 mg/kg and assessable for tumor response, the objective response rate (ORR) and disease control rate (DCR) were promising at 50% and 80%, respectively. Notably, one patient achieved complete response (CR) and has sustained this response for 20 months. Mabwell has also received approval from the China National Medical Products Administration (NMPA) for investigating the combination of 9MW2821 with immune checkpoint inhibitors for treating triple-negative breast cancer.

The clinical development of 9MW2821 extends beyond breast cancer, with Phase III trials initiated for locally advanced/metastatic urothelial carcinoma in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. Additionally, Phase I/II studies evaluating first-line combination therapies with PD-1 inhibitors have commenced. Mabwell is actively pursuing Phase III trial approvals for cervical and esophageal cancers while exploring frontline combination regimens, with clinical trial applications anticipated soon.

Acknowledging its potential, 9MW2821 has received Fast Track Designation (FTD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer.

9MW2821 represents a significant advancement as the first site-specific conjugated ADC targeting Nectin-4, developed by Mabwell utilizing proprietary platforms for ADC and antibody discovery. It holds the distinction of being the first Nectin-4-targeting ADC from a Chinese company to enter clinical trials and the first to demonstrate clinical efficacy in cervical, esophageal, and breast cancers. The drug's site-specific modification of antibodies through innovative conjugation technology allows for specific binding to Nectin-4 on tumor cell membranes, internalization, and subsequent release of cytotoxic drugs, leading to tumor cell apoptosis.



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