Pharma Focus Asia

Mabwell's Nectin-4 ADC Approved for Phase III Trial by CDE

Tuesday, December 12, 2023

Mabwell (688062.SH), an innovative biopharmaceutical company with a comprehensive industry chain, has obtained approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its submission. This submission pertains to a "A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial of 9MW2821 versus Investigator's Choice of Chemotherapy for Treating Unresectable Locally Advanced or Metastatic Urothelial Carcinoma in Patients Previously Treated with Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors." Mabwell is set to commence the Phase III clinical study of 9MW2821, a novel Nectin-4 targeting ADC, for the treatment of locally advanced or metastatic urothelial carcinoma in patients who have undergone prior treatment with platinum-based chemotherapy and PD-(L)1 inhibitors.

9MW2821, developed independently by Mabwell, represents the first of its kind among products in China with the same target to enter clinical trials. As of December 5, 2023, over 250 subjects have been enrolled in the ongoing clinical trials. In the Phase II clinical trial of 9MW2821, administered at a dose of 1.25 mg/kg, monotherapy demonstrated a noteworthy objective response rate (ORR) of 62.2% (95% CI: 44.8%–77.5%) and a disease control rate (DCR) of 91.9% (95% CI: 78.1%–98.3%) in patients with advanced urothelial carcinoma. The median progression-free survival (PFS) was 6.7 months (95% CI: 3.8–NR), and the median overall survival (OS) has not been reached.

The current stage involves multiple concurrent clinical trials for 9MW2821, encompassing combination therapy with other treatments in addition to monotherapy. Encouraging antitumor activity, coupled with favorable safety profiles, has been observed across various cancer types.

Urothelial carcinoma is a significant health concern in China, ranking among the top ten most prevalent cancers, characterized by its propensity for metastasis and recurrence. Advanced urothelial carcinoma poses a substantial disease burden, impacting patient survival and quality of life.

9MW2821, a Nectin-4 targeting ADC, is a product of Mabwell's world-class ADC development platform and automated high-throughput antibody discovery platform. Leveraging proprietary conjugate technology linkers and an optimized ADC conjugation process, 9MW2821 achieves site-specific modification of antibodies. The novel ADC can specifically bind to Nectin-4 on the cell membrane surface, undergo internalization, release cytotoxic drugs, and induce apoptosis in tumor cells. Mabwell is actively conducting clinical trials across various indications, including urothelial carcinoma and cervical cancer. Currently, the R&D progress of 9MW2821 ranks first in China and second globally. It has also become the first to report preliminary clinical data in cervical cancer among products with the same target worldwide.



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