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Text|Pharmaceutical Mission Hills
On September 23, Lion TCR Pte Ltd announced that the US FDA has approved its LioCyx-M004 New Drug (IND) application to start a phase 1b/2 international multi-center clinical trial (clinical trial name: LIBERO) , Used to treat primary hepatitis B virus (HBV)-related advanced hepatocellular carcinoma (HCC)
Lion Bio is a clinical-stage biotechnology company focusing on T cell immunotherapy.
In 2020, there will be more than 900,000 new liver cancer patients worldwide, 90% of which are hepatocellular carcinoma
LioCyx-M004 is an autologous T cell product developed by Lion Biotech.
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.
This FDA-approved IND clinical study mainly used LioCyx-M004 as a single-drug therapy to further evaluate its efficacy.
(The original text has been deleted)
Reference materials:
[1] Koh et al, Mol.
[2]Kah et al, J.
[3]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;
[4] Chen W et al.
[5]Fu-Sheng Wang et al.
