Breakthrough progress! Luopu Biology (02157) has completed the enrollment of the first patient in Phase II clinical trial for liver cell carcinoma.

Recently, the targeted GPC3 antibody-drug conjugate (ADC) MRG006A developed independently by LivzBio (02157) successfully enrolled the first patient in the Phase II clinical trial for advanced hepatocellular carcinoma (HCC) indications! MRG006A is the world's first GPC3-targeted ADC drug to enter Phase II clinical trials. MRG006A (GPC3 ADC) was developed based on LivzBio's next-generation Hi-TOPi ADC technology platform, which precisely binds to GPC3-positive tumor cells with antibodies, releases toxins within the tumor, and achieves precise killing of tumor cells. Hepatocellular carcinoma (HCC) is a globally high-incidence malignant tumor, and most patients are diagnosed at advanced stages. After first-line treatment failure, options for second-line therapy and effectiveness are limited. In this context, the innovative ADC drug MRG006A targeting the liver cancer-specific target GPC3 has attracted considerable attention. According to People's Daily, during the "GPC3-ADC liver cancer expert advisory meeting" on July 15th, Dr. Zhao Hong, director of the Department of Liver and Gallbladder Surgery at the Cancer Hospital of the Chinese Academy of Medical Sciences, stated in an interview, "GPC3 is a cancer embryonic antigen involved in cell proliferation, differentiation, migration, and apoptosis. It is hardly expressed in normal tissues, but highly expressed in 70%-80% of liver cancers, hence considered as the 'golden' target for precise targeting of liver cancer cells." He mentioned, "As the GPC3-targeted ADC drug MRG006A entering the clinical stage, its innovative value is also reflected in technological breakthroughs." Dr. Zhao explained: MRG006A is developed based on the Hi-TOPi technology platform, similar to a "precision-guided missile" - using monospecific antibodies targeting GPC3 as a "navigation system" to precisely target liver cancer cells, then carrying cytotoxic drugs (topoisomerase I inhibitors) as the "warhead" to achieve specific killing of tumor cells. This mechanism retains potent anti-tumor effects while reducing damage to normal cells due to its specificity, addressing the issue of high toxicity of traditional cytotoxic drugs. Clinical data shows that its adverse reactions primarily focus on liver function abnormalities (elevated bilirubin, transaminase) and mild bone marrow suppression, which are overall controllable, further confirming its clinical feasibility. From a clinical perspective, the performance of MRG006A has shown significant potential. Dr. Huang Zhen, deputy director of the Department of Liver and Gallbladder Surgery at the Cancer Hospital of the Chinese Academy of Medical Sciences, mentioned, "In a Phase I clinical trial, dose escalation studies achieved results beyond expectations. In the dosing group, two GPC3-positive patients showed significant tumor reduction, which is encouraging." The advancement of the Phase II clinical study of MRG006A is not only a significant breakthrough in LivzBio's ADC pipeline development but also holds promise in filling the clinical gap in liver cancer treatment.