Mabwell Gets NMPA Nod for TNBC Nectin-4 ADC Trial

SHANGHAI, July 15, 2024 — Mabwell (688062.SH), a pioneering biopharmaceutical company with an extensive industry chain, disclosed that its new Nectin-4 targeting ADC, designated as 9MW2821, has gained approval from the NMPA to commence Phase II clinical trials. This trial will assess the use of 9MW2821 alone or combined with a PD-1 inhibitor for treating triple-negative breast cancer (TNBC).

The Phase II trial aims to determine the efficacy and safety of 9MW2821, either as a standalone treatment or in combination with a PD-1 inhibitor, for patients with locally advanced or metastatic TNBC. The study is divided into two cohorts: Cohort A will focus on patients with locally advanced or metastatic TNBC who have previously received taxane/anthracycline-based chemotherapy and topoisomerase inhibitor-based ADC treatment, and they will be administered 9MW2821 monotherapy. Cohort B will involve patients with locally advanced or metastatic TNBC who have not undergone prior systemic therapy, and they will receive a combination of 9MW2821 and a PD-1 inhibitor.

Previously presented clinical data at the 2024 ASCO Annual Meeting highlighted promising results among 20 evaluable patients with locally advanced or metastatic TNBC treated with 9MW2821. The objective response rate (ORR) was 50.0%, and the disease control rate (DCR) reached 80.0%. Additionally, the median progression-free survival (mPFS) was observed at 5.9 months, while the median overall survival (mOS) has not yet been reached. Notably, one patient achieved a complete response (CR), maintaining this status for 20 months and continuing to do so. Furthermore, 9MW2821 has recently been granted Fast Track Designation (FTD) by the U.S. FDA for treating locally advanced or metastatic Nectin-4 positive TNBC.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC created by Mabwell using its ADC platform and automated high-throughput hybridoma antibody molecular discovery platform. This drug is the first of its kind developed by a Chinese company to reach clinical trials, and it is the first therapeutic drug targeting Nectin-4 worldwide to show clinical efficacy in cervical cancer (CC), esophageal cancer (EC), and breast cancer. In February 2024, 9MW2821 received FTD from the FDA for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). In May 2024, it was also granted Orphan Drug Designation (ODD) and FTD for treating EC and recurrent or metastatic CC that progressed after prior treatment with platinum-based chemotherapy. In July 2024, it received FTD for locally advanced or metastatic Nectin-4 positive TNBC.

The drug utilizes site-specific modification of antibodies through proprietary conjugate technology linkers and an optimized ADC conjugation process. Post-injection, 9MW2821 specifically targets and binds to Nectin-4 on the cell membrane surface, is internalized, releases a cytotoxic drug, and induces tumor cell apoptosis.

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with a comprehensive value chain in the pharmaceutical industry. The company provides effective and accessible therapies and innovative medicines to meet global medical needs. Established in 2017, Mabwell has developed an advanced R&D system encompassing target discovery, early discovery, druggability, preclinical, clinical research, and manufacturing transformation. With 14 pipeline products at various stages of development, including 10 novel drug candidates and 4 biosimilars, Mabwell focuses on therapeutic areas such as oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases. Three products have been approved and commercialized, one product has been filed for marketing authorization, and three are in pivotal trials. Mabwell has also undertaken significant national scientific and technological projects. The company’s Taizhou factory offers robust in-house manufacturing capabilities compliant with international GMP standards and has passed the EU QP Audit. Mabwell is currently expanding its manufacturing base in Shanghai and constructing an ADC commercial manufacturing base in Taizhou. The company's mission is "Explore Life, Benefit Health," and their vision is "Innovation, from ideas to reality."