Mabwell's Nectin-4 ADC Drug Approved for Triple-Negative Breast Cancer Trials

Mabwell (stock code: 688062.SH), an innovative entity in biopharmaceuticals, has announced a significant milestone: its Nectin-4 targeted antibody-drug conjugate (ADC) known as 9MW2821 has received the green light from the National Medical Products Administration (NMPA) for a phase II clinical trial in treating triple-negative breast cancer (TNBC). This trial will assess the safety and effectiveness of 9MW2821 both as a standalone treatment and in conjunction with PD-1 inhibitors.

The phase II trial will be segmented into two cohorts to examine 9MW2821's therapeutic impact on different patient groups. The first cohort will include patients who have undergone prior therapy with taxanes, anthracyclines, and topoisomerase inhibitors but have experienced disease progression in their locally advanced or metastatic TNBC. These patients will be administered 9MW2821 alone. The second cohort will consist of patients with locally advanced or metastatic TNBC who have not received any previous systemic treatments. These patients will receive a combination therapy of 9MW2821 and a PD-1 inhibitor.

Importantly, data from early clinical studies of 9MW2821 were showcased at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. The results indicated an overall response rate of 50.0% and a disease control rate of 80.0% among 20 evaluable TNBC patients. The median progression-free survival reached 5.9 months, with one patient achieving a complete response and remaining progression-free for an outstanding 20 months.

In recent developments, 9MW2821 has also received a breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for its role in treating locally advanced or metastatic Nectin-4-positive TNBC.

9MW2821 is a product of Mabwell's proprietary ADC platform and high-throughput hybridoma screening technology. It targets Nectin-4 and is the first drug of its kind to reach clinical stages in China. Additionally, it is the first Nectin-4 targeted therapy to demonstrate clinical efficacy in various indications including cervical cancer, esophageal cancer, and breast cancer on a global scale.

For Mabwell, the approval of this clinical trial marks a critical milestone in its oncology pipeline and represents a significant breakthrough in the development of innovative treatments for hard-to-treat cancers like TNBC. The company's dedication to 9MW2821 underscores its commitment to improving the quality of life for cancer patients through pioneering therapies.