Tvardi Therapeutics’ TTI-101 Gets Fast Track Status
The FDA has granted Tvardi Therapeutics’s TTI-101 a Fast Track designation for treatment of patients with relapsed/refractory locally advanced, unresectable or metastatic hepatocellular carcinoma.
TTI-101 is an orally delivered inhibitor of STAT3, a protein that plays a key role in initiating liver tumors. The drug candidate also promotes immunosuppression of tumors.
The drug has been investigated in a phase 1 trial in patients with advanced solid tumors who had failed all lines of therapy. Tvardi plans a phase 2 study of TTI-101 as a monotherapy and in combination with approved therapies across first-, second- and last-line hepatocellular cancer patients.