Lion Biotech announces that the FDA has approved the IND clinical application of its leading product LioCyx-M004 for the treatment of hepatocellular carcinoma

Singapore and Guangzhou, China and Los Angeles, September 23, 2021/PRNewswire/ - Lion TCR Pte Ltd, a clinical-stage biotechnology company focusing on original TCR T-cell immunotherapy, is very We are honored to announce that the US Food and Drug Administration (FDA) has approved the new drug (IND) application for its leading product LioCyx-M004 to start a phase 1b/2 international multi-center clinical trial (clinical trial name: LIBERO)

This new drug approval allows Lion Biotech to start an IND clinical trial of its leading product LioCyx-M004 for the treatment of primary HBV-related advanced hepatocellular carcinoma (HCC)

In 2020, there will be more than 900,000 new liver cancer patients worldwide, 90% of which are hepatocellular carcinoma (HCC)

In the completed phase 1 clinical trial, LioCyx-M004 showed good safety, no cytokine storm and neurotoxicity occurred, and tumor remission was observed, and the remission time lasted 27.

Dr.

Dr.

About Lai En Biomedical Co.

Lion TCR Pte Ltd is a clinical-stage biotechnology company focusing on T-cell immunotherapy for the treatment of diseases caused by cancer and viruses

Introduction of leading product LioCyx-M004

LioCyx-M004 is an autologous T cell modified to express the hepatitis B virus (HBV) specific T cell receptor (TCR)

references:

Koh et al, Mol.

Kah et al, J.

Tan et al, “Use of Expression Profiles of HBV-DNA Integrated Into Genomes of Hepatocellular Carcinoma Cells to Select T Cells for Immunotherapy”, Gastroenterology, 2019;

Chen W et al.

Fu-Sheng Wang et al.

Source: Lion TCR