Posted by Michael Wonder on 26 Dec 2021
Lion TCR receives FDA fast track designation for its HBV specific TCR T cell therapy for hepatocellular carcinoma
23 December 2021 - Lion TCR today announced that it has received fast track designation from U.S. FDA for LioCyx-M004, autologous T cells transfected with mRNA encoding hepatitis B surface antigen specific TCR, for the treatment of HBV related hepatocellular carcinoma.
This designation was granted based on that the efficacy of LioCyx-M004, as demonstrated by an improvement in the overall survival in patients with HBsAg positive hepatocellular carcinoma relapsed or refractory to prior systemic treatment.
