Mabwell's Novel Nectin-4 ADC Cleared for Phase III Cervical Cancer Trial

SHANGHAI, Aug. 23, 2024 -- Mabwell (688062.SH), a leading biopharmaceutical company, has announced the approval of its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The submission pertains to the Phase III clinical study titled "A Randomized, Open-label, Phase III Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Cervical Cancer Who Progressed on or after Platinum-based Chemotherapy." This approval paves the way for Mabwell to commence the Phase III clinical trial, aimed at assessing the effectiveness and safety of 9MW2821 for patients suffering from recurrent or metastatic cervical cancer (CC) post platinum-based chemotherapy.

9MW2821 is a pioneering Nectin-4 targeting antibody-drug conjugate (ADC) developed by Mabwell. It marks the first Nectin-4-targeting ADC to enter clinical trials among Chinese companies and globally, it is the first to reach Phase III clinical trials for treating cervical cancer. The drug has undergone multiple clinical trials for various cancers including urothelium carcinoma, cervical cancer, esophageal cancer, and breast cancer, enrolling over 400 participants. Results from these trials have shown promising therapeutic efficacy and safety.

Patients with recurrent or metastatic cervical cancer face limited treatment options and generally poor outcomes. In the cervical cancer expansion cohort of the Phase I/II study, a high detection rate of Nectin-4 expression was observed, with 91.87% of participants showing Nectin-4 presence and 73.98% showing Nectin-4 IHC 3+ expressions. In this study, 53 cervical cancer patients received at least one dose of 9MW2821 and were evaluated for efficacy. All patients had previously undergone doublet platinum-containing chemotherapy, with 51% also having received bevacizumab and 58% treated with immune checkpoint inhibitors. The objective response rate (ORR) and disease control rate (DCR) among these patients were 35.8% and 81.1%, respectively. The median progression-free survival (mPFS) was 3.9 months, and the median duration of response (DOR) was 7.2 months. Furthermore, the median overall survival (OS) had not been reached, with a 12-month OS rate standing at 74.6%. Notably, patients with Nectin-4 IHC 3+ had an ORR of 43.6%.

These findings underscore the positive therapeutic potential of 9MW2821 for cervical cancer patients. Mabwell is currently advancing its clinical research to evaluate first-line combination therapies scientifically.

Cervical cancer is the fourth most common cancer and the fourth leading cause of cancer death among women worldwide. According to the "World Cancer Report 2020" by the International Agency for Research on Cancer (IARC), there were 600,000 new cases and 340,000 deaths globally due to cervical cancer in 2020. Data from the National Cancer Center in China published in February 2024 indicated that there were 150,700 new cases and 55,700 deaths from cervical cancer in China in 2022, showing a significant increase from the figures reported for 2016.

9MW2821 stands as the first site-specific conjugated novel Nectin-4 targeting ADC developed using Mabwell's proprietary conjugation technology. The drug has garnered significant recognition, earning Fast Track Designation from the FDA for multiple cancer treatments, and Orphan Drug Designation for esophageal cancer. Additionally, it has received Breakthrough Therapy Designation from the CDE of NMPA.

Mabwell is an innovation-driven biopharmaceutical company committed to developing effective and accessible therapies to meet global medical needs. Since its inception in 2017, the company has built an advanced R&D system covering all stages of drug development. Mabwell has a diverse pipeline of 14 products, including 10 novel drug candidates and four biosimilars, with three products already approved and commercialized. The company is actively involved in numerous national and regional scientific projects and possesses robust manufacturing capabilities compliant with international standards.

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