NEW YORK – Lion TCR on Tuesday said the US Food and Drug Administration cleared its investigational new drug application seeking permission to begin a Phase II trial to test its mRNA-encoded T-cell receptor (TCR) T-cell therapy Liocyx-M004 in hepatitis B virus (HBV)-related hepatocellular carcinoma.
In the trial, investigators with the Singapore-based company will assess Liocyx-M004 alone and in combination with Eisai's tyrosine kinase inhibitor Lenvima (lenvatinib). Lion believes that the drug combination will have a synergistic anti-cancer effect.
"HBV-specific T cells are often functionally exhausted, leading to a significant impairment in their ability to eliminate liver cancer cells and HBV-infected liver cells with HBV-DNA integration," Lion Chief Medical Officer and Chief Operating Officer Tina Wang said in a statement. "Our research has shown that HBV-specific TCR-T cells can effectively target and destroy these cancerous cells."
Through adoptive transfer and supplementation of autologous HBV-specific TCR-T cells, Lion aims to restore the HBV-specific T-cell pool in patients with HBV-related hepatocellular carcinoma, enabling the targeted killing of liver cancer cells and liver cells infected with HBV. In a previous clinical study, patients with HBV-related hepatocellular carcinoma on Liocyx-M004 survived a median 33.1 months.
Lion is studying HBV-directed TCR T-cell therapy in several other early clinical trials, including a Phase Ib/II multicenter trial in the US and single-center trials in Singapore and Beijing.
Lion also plans to advance development of its artificial intelligence-powered TCR discovery platform to generate off-the-shelf therapies for other solid tumors, such as lung, breast, and gastrointestinal cancers, based on mRNA delivered via lipid nanoparticles.