Mabwell Therapeutics’ 9MW2821 Receives US FDA orphan Drug Status

Mabwell Therapeutics’ 9MW2821 Receives US FDA orphan Drug Status

By, Admin 13 May 2024

Mabwell Therapeutics’ drug candidate, 9MW2821 to treat esophageal cancer receives US FDA orphan drug status

Overview

Mabwell Therapeutics, Inc, an innovation-driven biopharmaceutical company with entire industry chain, announced that its self-developed novel Nectin-4-targeting ADC (R&D code: 9MW2821) has been granted Orphan Drug Designation (ODD) by the US FDA, for the treatment of esophageal cancer.

ODD

  • The US FDA grants orphan drug designation to treatments for rare diseases in the United States that affect fewer than 200,000 patients. 
  • Orphan drug designation offers policy benefits to drug developers, including as aid with medication development, tax credits for a part of clinical trial expenditures, and seven years of market exclusivity upon approval.

FTA for 9MW2821

  • 9MW2821 was previously given Fast Track Designation by the US FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. 
  • It is the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical effectiveness data for an esophageal cancer indication.

9MW2821

  • 9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. 
  • Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors.

Phase III Clinical Study

  • The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L) inhibitor therapy. 
  • The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. 
  • 9MW2821 was granted Fast Track Designation and Orphan Drug Designation by the US FDA. 
  • Currently, 9MW2821 is the first therapeutic drug candidate targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma.

Mabwell Fulfilling Medicinal Needs

  • Mabwell provides 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, products have been approved and commercialized, product has been filed for MA approval, three products are in pivotal trials. 
  • Mabwell has also undertaken one national major scientific and technological special project for ‘Significant New Drugs Development’, two projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects.

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