NEW YORK – Lion TCR on Thursday said the US Food and Drug Administration has cleared an investigational new drug application for its autologous T-cell receptor therapy LioCyx-M004 for certain liver cancer patients allowing for the start of a Phase Ib/II trial.
Lion will now begin evaluating the therapy for advanced hepatitis B virus (HBV)-related hepatocellular carcinoma, which comprises roughly 80 to 90 percent of HCC in China. Within the study, Singapore-based Lion plans to evaluate LioCyx-M004 as a monotherapy and in combination with lenvatinib (Eisai's Lenvima), which is an established first-line HCC treatment. Lion believes LioCyx-M004 could improve immunogenicity in patients with immunosuppressive tumor microenvironments and improve their outcomes on immunotherapy.
The autologous therapy involves harvesting T cells from HCC patients, transfecting them with mRNA encoding HBV antigen-specific T-cell receptors, and reinfusing them as treatment. LioCyx-M004 has already been evaluated in a Phase I study in primary HBV-related HCC, in which the treatment was well tolerated, the disease control rate was 60 percent, the median duration of response was 27.7 months, and the median overall survival was 33.1 months.
According to Tina Tingting Wang, Lion's chief operating officer and chief medical officer, patient recruitment for the upcoming study will begin at the City of Hope Comprehensive Cancer Center.
"LioCyx-M004, with its unique mechanism of action and its excellent safety profile and radiological tumor response, has the potential to become a first-in-class TCR T-cell therapy for HCC," Wang said. "We also have a strong scientific rationale for the use of our TCR-T therapy in combination with other therapies to extend its effectiveness."