Breakthrough Approval for Mabwell's Nectin-4 ADC Drug in Clinical Trials for Triple-Negative Breast Cancer Treatment

Mabwell (stock code: 688062.SH), as an innovative company in the field of bioparmaceuticals, has announced an important news: its development of Nectin-4 targeted antibody drug conjugate (ADC) innovative drug product (R&D code: 9MW2821) has received approval from the National Medical Products Administration (NMPA) to conduct a phase II clinical trial in triple-negative breast cancer (TNBC), which will evaluate the efficacy and safety of 9MW2821 as monotherapy or in combination with PD-1 inhibitors.

The approval of the phase II clinical trials will be divided into two research queue, to delve into 9 mw2821 in different groups of patients with therapeutic effect. Queue will include those who have received A yew class/anthracycline-based chemotherapy and to topoisomerase inhibitors as the carrier of the antibody coupling drug treatment, but still progression in patients with locally advanced or metastatic TNBC, patients will receive 9 mw2821 monotherapy. Cohort B will include patients with locally advanced or metastatic TNBC who have not received previous systemic therapy and who will receive 9MW2821 in combination with a PD-1 inhibitor.

Notably, early clinical study results of 9MW2821 were presented at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO), showing an overall response rate of 50.0% and a disease control rate of 80.0% in 20 evaluable TNBC patients. Median progression-free survival reached 5.9 months. One of these patients achieved a complete response and maintained progression-free status for an impressive 20 months.

In addition, 9MW2821 was recently granted a breakthrough therapy designation by the Food and Drug Administration (FDA) - an innovative agent for the treatment of locally advanced or metastatic Nectin-4-positive TNBC.

9 mw2821 is using its Mabwell company independent research and development of ADC platform and high flux hybridoma antibodies detection technology, the development of the targets of antibodies against Nectin - 4 coupling drugs. It is not only the first Nectin-4 targeted drug to enter the clinical stage in China, but also the first Nectin-4 targeted drug to show clinical efficacy in multiple indications such as cervical cancer, esophageal cancer and breast cancer worldwide.

The clinical trial has been approved, for Mabwell company, is in the tumor treatment is an important milestone in the history of the pipeline, also marks the company in the field of difficult to treat cancer for TNBC, innovative therapy on the development of new breakthrough. The company's commitment to 9MW2821, a Nectin-4 ADC, reflects its commitment to improving the quality of life of cancer patients.