ISU Abxis Received IND Approval for ‘ISU104’

  • 관리자
  • 2017-08-18
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The Korean Ministry of Food and Drug Safety (MFDS) approved the Investigational New Drug Application (IND) for ISU Abxiss ‘ISU104(Human Monoclonal Antibody Targeting ErbB3)’ in August, 2017.


‘ErbB3’ is a receptor protein that is overexpressed in various types of human cancers. It is a protein that plays an important role in tolerance of ‘EGFR’ and ‘HER2’ targeted anti-cancer drugs. Binding with cancer-induced signaling receptor ‘ErbB1’ or ‘ErbB2’, ‘ErbB3’ generates cancer cells to grow.


ISU Abxis plans to initiate a Phase 1 clinical dose finding study in patients with advanced solid tumors to assess the safety, tolerability and pharmacokinetics of ‘ISU104’ in the third quarter of 2017.