On August 19, 2018 Lion TCR Pte. Ltd., a Singapore-based Biotech company reported that it has receives approval from Health Sciences Authority (HSA), Singapore, for its Phase I/II multicentre clinical study of its product candidate (LioCyx) for treatment of relapsed liver cancer post-liver transplantation (Press release, Lion TCR, AUG 19, 2018, View Source [SID1234528981]). The first such trial in Singapore and for the region that uses precision T cell receptor (TCR) immune cell therapy to target Hepatitis B virus (HBV)-related liver cancer, which forms at least 80% of liver cancers in Asia. 80% of the 800,000 new liver cancer cases in the world yearly are diagnosed in Asia Pacific, including China, Vietnam, Thailand, Indonesia, South Korea and Singapore. Liver cancer is the world’s third most deadly cancer with very limited treatment options and poor treatment outcome. There is currently no effective treatment available for liver cancer relapsed patients post-liver transplantation.
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LioCyx is developed by Lion TCR’s scientific founder, Prof. Antonio Bertoletti, a world-renowned HBV-liver cancer clinician scientist. Several Investigator-sponsored trials of LioCyx in Singapore and China have showed results of good safety profile and encouraging signs of efficacy. "We are very delighted with the approval of Phase I/II clinical trial of our LioCyx, the first engineered TCR-T cell therapy for treatment of liver cancer in Singapore. It is an utmost encouragement on the recognition of innovative therapy for patients in need. Singapore HSA has been very efficient, transparent and professional in reviewing our application for the clinical trial of this innovative immunotherapy", said Dr. Victor Li Lietao, founder and CEO of Lion TCR.
Patients recruitment for the Phase I/II clinical trial will begin with National University Hospital (NUH), Singapore. Lion TCR is in the midst of including more medical centres in Singapore and China into the trial.