Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC to Initiate Phase III Clinical Trial for the Treatment of Cervical Cancer

SHANGHAI, Aug. 23, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the "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" has been approved. The company will initiate the Phase III clinical study to assess the efficacy and safety of 9MW2821 in patients with recurrent or metastatic cervical cancer (CC) that has progressed on or after platinum-based chemotherapy.

9MW2821, a novel Nectin-4 targeting ADC developed by Mabwell, is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. It's also the first Nectin-4-targeting ADC to enter phase III clinical study for the treatment of CC worldwide. Multiple clinical studies have been conducted for urothelium carcinoma, cervical cancer, esophageal cancer, and breast cancer, and more than 400 subjects have been enrolled. The results of the existing clinical studies have demonstrated outstanding therapeutic efficacy and safety.

Treatment options and outcomes for patients with recurrent or metastatic cervical cancer remain limited. In the cervical cancer expansion cohort of the phase I/II study, the detection rate of Nectin-4 expression was 91.87%, and the detection rate of Nectin-4 IHC 3+ was 73.98%. 53 CC patients received at least one dose of 9MW2821 and were evaluable for efficacy assessment. All of the patients had received doublet platinum-containing chemotherapy, 51% patients had received bevacizumab, and 58% patients had received immune checkpoint inhibitor. ORR and DCR in 53 CC patients were 35.8% and 81.1%, respectively. The median progression-free survival (mPFS) and duration of response (DOR) was 3.9 months and 7.2 months, respectively. Median overall survival (OS) was not reached yet and 12-months OS rate was 74.6%. Among patients with Nectin-4 IHC 3+, the ORR was 43.6%.

The results of the above studies indicate that 9MW2821 has a positive therapeutic effect in patients with cervical cancer. The company is in the process of scientifically evaluating and advancing the conduct of clinical studies on first-line combination therapies.

About Cervical Cancer

Cervical cancer is the 4^th most common neoplasm and the 4^th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and also the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer (CC), esophageal cancer (EC) and breast cancer. In 2024, 9MW2821 has been granted Fast Track Designation by FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has been granted Orphan Drug Designation by FDA for the treatment of EC, and also Breakthrough Therapy Designation by CDE of NMPA.

9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com/en.

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