Lion TCR Announces First-Ever Global Enrollment of IND Clinical Trial Subject for HBV Antigen-Targeted TCR-T Therapy LioCyx-M

Singapore and Guangzhou, ChinaAugust 2, 2022PR Newswire -- Guangzhou Laien Biological Medicine Co., Ltd. is pleased to announce that the IND clinical trial of one of its core products, LioCyx-M, a TCR-T cell therapy precisely targeting hepatitis B virus (HBV) antigens for the treatment of HBV-related hepatocellular carcinoma (HBV-HCC), has completed the enrollment of its first participant on August 2, 2022. This marks the world's first IND clinical trial participant enrolled for a therapy targeting HBV viral antigens, representing a milestone achievement.

Liver Cancer is the Third Leading Cause of Cancer Deaths Worldwide, and Hepatocellular Carcinoma is the Most Common Subtype. HBV Infection is a Major Cause of Hepatocellular Carcinoma. In China, 80%-90% of Hepatocellular Carcinoma Cases are Associated with HBV Infection, with Over 300,000 New Patients Annually. Unfortunately, Due to the Subtle Symptoms in the Early Stages, It is Difficult for Patients to Detect Them Early. By the Time Symptoms Become Obvious, More Than 90% of Hepatocellular Carcinoma Patients Are Already at an Intermediate or Advanced Stage, With a Survival Period Typically Ranging from Only 6 to 20 Months.

Currently, the efficacy of approved treatments is unsatisfactory, and there is an urgent need for new therapies to be advanced into clinical practice. Guangzhou Laien Biological Medicine Co., Ltd. has previously received approval from the U.S. FDA for the world’s first Phase 1b/2 IND clinical trial using TCR-T therapy targeting HBV viral antigens to treat liver cancer. It also obtained Fast Track designation from the FDA. The enrollment of participants in this IND clinical trial marks that Laien Bio continues to maintain a globally leading position in this field, actively striving to bring more effective treatment options to patients.

Dr. Tingting Wang, Chief Medical Officer and Chief Operating Officer of Guangzhou Laien Biological Medicine Co., Ltd., pointed out: "Liver cancer patients usually have low immunity and their physical condition can hardly withstand therapies with significant toxic side effects. Therefore, safe and effective innovative therapies are particularly important. Our TCR-T cell therapy introduces HBV-TCR through mRNA electroporation, and the participants do not need to undergo lymphodepletion, a pretreatment with potential risks. This approach not only effectively controls and reduces potential risks during the implementation of clinical protocols but also eliminates long-term safety concerns."

Dr. Xiaoming Peng, Managing Director and CEO of LioCyx, stated: "The enrollment of the first subject in this clinical trial further highlights the significance of LioCyx-M as an innovative therapy for liver cancer. LioCyx will continue to strive to become a global leading TCR-T cell therapy platform company, applying First-in-Class TCR-T cell immunotherapy to benefit liver cancer patients, and aiming to become a benchmark enterprise in tumor immunotherapy."