Category: ODD/BTA/FTA Status Region: North America · United States Company: Zielbio Inc

US FDA grants orphan drug designation to ZielBios ZB131 to treat pancreatic cancer

US FDA grants orphan drug designation to ZielBios ZB131 to treat pancreatic cancer
ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead programme, ZB131, for the treatment of treatment of pancreatic cancer, a rare solid-tumour cancer originating from the pancreas. ZB131 is a proprietary monoclonal antibody with a high affinity and specificity for cancer-specific plectin (CSP), a cell surface protein identified in a wide range of cancers that correlates with poor prognosis and aggressive tumours, including pancreatic cancer. ZielBio previously received Orphan Drug Designation for ZB131 for the treatment of cholangiocarcinoma (bile duct cancer).

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