Mabwell Updates on 9MW2821 Trial in Triple-Negative Breast Cancer

In a recent announcement, Mabwell (688062.SH), a biopharmaceutical company driven by innovation, revealed significant progress in the clinical trials of its novel antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4 for the treatment of triple-negative breast cancer (TNBC). This update highlights critical milestones in the ongoing development and potential future applications of 9MW2821 across various cancer types.

The study focuses on 20 patients with locally advanced or metastatic TNBC who were administered a 1.25 mg/kg dose of 9MW2821. The results so far are promising, showing an objective response rate (ORR) of 50% and a disease control rate (DCR) of 80%. One patient achieved a complete response (CR) and has maintained this status for 20 months. Additionally, Mabwell's investigational new drug (IND) application for combining 9MW2821 with an immune checkpoint inhibitor to treat TNBC has been accepted by the China National Medical Products Administration (NMPA).

9MW2821 is also undergoing clinical trials for various other cancer indications. A Phase III study for patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors has commenced, with the first patient already enrolled. Furthermore, a Phase I/II study assessing first-line combination therapy options with a PD-1 inhibitor has also started, and the initial patient enrollment is complete.

Mabwell is actively pursuing Phase III clinical trial approval for 9MW2821 in cervical and esophageal cancers. The company is also conducting scientific evaluations of front-line combination regimens and plans to submit a clinical trial application shortly. The U.S. Food and Drug Administration (FDA) has granted 9MW2821 Fast Track Designation (FTD) and Orphan Drug Designation (ODD) for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer, respectively.

Developed using Mabwell's ADC platform and high-throughput hybridoma antibody discovery technology, 9MW2821 is the first site-specific conjugated ADC targeting Nectin-4 developed by a Chinese company and globally the first to show clinical efficacy in cervical, esophageal, and breast cancers. With the proprietary conjugate technology linkers and optimized ADC conjugation process, 9MW2821 specifically binds to Nectin-4 on the cell membrane, internalizes, releases a cytotoxic drug, and induces apoptosis in tumor cells.

Mabwell, established in 2017, is dedicated to developing effective and accessible therapies to meet global medical needs. The company has a comprehensive R&D system covering target discovery, early-stage discovery, preclinical development, clinical research, and manufacturing. Mabwell’s pipeline includes 14 products in various stages, comprising 10 novel drug candidates and 4 biosimilars, with a focus on oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases. Of these, three products are already approved and commercialized, one is filed for marketing approval, and three are in pivotal trials.

Mabwell’s manufacturing capabilities adhere to international Good Manufacturing Practice (GMP) standards, regulated by the NMPA, FDA, and EMA. Their Taizhou factory has passed the European Union Qualified Person (EU QP) audit, and a large-scale manufacturing base in Shanghai is under construction. The company’s mission is "Explore Life, Benefit Health," and it strives to turn innovative ideas into reality.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!