Nanjing, China, October 29th, 2020--TransThera Biosciences announces today the Investigational New Drug (IND) application of TT-00420 for the indication of cholangiocarcinoma (CCA) has been submitted to Food and Drug Administration (FDA) in the United States.
TT-00420 is a spectrum-selective multi-kinase inhibitor that possesses novel mechanism to tackle various forms of CCA. Currently TT-00420 is under global phase 1 development in multiple clinical sites in the US and China. Today’s FDA filing of TT-00420 for new indication follows the original IND approval in 2018 for solid tumors as well as FDA orphan drug designation in 2019 for CCA.
"Based on the preliminary but encouraging data as well as our communication with regulatory agency, we have achieved another important milestone in our clinical development of TT-00420. We believe the filing and upcoming clearance of the second IND will lay down the foundation for late stage development and expedite future commercial approval of TT-00420 for CCA patients." commented by Dr. Frank Wu, CEO of TransThera.
Cholangiocarcinoma is a cancer that forms in the bile ducts with poor prognosis. Common treatment options for cholangiocarcinoma include surgery, chemotherapy, and recently approved targeted therapy. However, recurrence is common and survival rate is low. Developing innovative drugs to treat CCA will fulfill highly unmet medical needs.