Lion TCR's GZL-016, the World’s First mRNA-Encoded TCR-T Therapy for HBV-Related Hepatocellular Carcinoma, Receives Clinical Trial Approval in China

GZL-016 InjectionIt is an autologous T-cell therapy that uses mRNA to encode and express TCR targeting the hepatitis B virus surface antigen, granting T cells the ability to specifically recognize and kill hepatitis B virus-related hepatocellular carcinoma. GZL-016 Injection effectively utilizes the transient expression characteristics of mRNA and combines multiple infusions to ensure both safety control and efficacy.And the patient inNo need for clear drip before treatment, further improving the safety and accessibility of patient medication, achieving a "dual guarantee" of efficacy and controllable safety.

Dr. Tingting Wang, Chief Medical Officer and Chief Operating Officer of Guangzhou Laien Biological Medicine Co., Ltd."By applying this therapy, we have observed encouraging clinical efficacy in patients with advanced liver cancer both in and outside of China, including tumor shrinkage, disappearance, accompanied by a reduction in the tumor marker AFP and an extension in survival. In terms of safety, no cytokine storms or neurotoxicity reactions were observed, indicating that the mRNA-encoded TCR-T therapy is a safe and effective treatment. We look forward to continuing to expand the patient sample size, collecting more clinical data, and accelerating into the next phase of clinical trials. Currently, Guangzhou Laien Biological Medicine Co., Ltd. is working hand-in-hand with globally renowned comprehensive oncology specialty hospitals to fully advance the clinical patient enrollment. The clinical enrollment work in China is also proceeding intensively, with the hope of providing new treatment opportunities to eligible Chinese patients with advanced liver cancer as soon as possible."

As a pioneer and innovator in the field of mRNA-encoded TCR-T cell therapy for solid tumors, Guangzhou Laien Biological Medicine Co., Ltd. is committed to bringing new hope to patients through cutting-edge biotechnology.The layout of the mRNA technology platform and the AI-empowered TCR discovery and validation platform is actuallyDual-Driven, jointly breaking through the ceiling of Laien Bio's innovative drugs.

Dr. Peng Xiaoming, CEO of Guangzhou Laien Biological Medicine Co., Ltd.Believes: "We must prove that the company can not only treat liver cancer, but also utilize these technology platforms. Laien Biological MedicineTherapies based on mRNA can be developed for different targets, covering a broader range of disease areas."At the same time, it can not only provide personalized autologous cell therapy, but also offer highly accessible off-the-shelf products for treating both cancerous and non-cancerous diseases." In Dr. Peng Xiaoming's view, the combination of mRNA and TCR technology has laid the technical foundation for off-the-shelf in vivo TCR-T product treatments, and the company is actively making strategic arrangements.

References:

[1]BrayF, LaversanneM, SungH, et al. Global cancer statistics 2022:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2024, 74(3):229-263. DOI: 10.3322/caac.21834. Epub ahead of print.

[2] Miao Weigang, Zhou Jinyi, Han Renqiang. Analysis of Global Liver Cancer Epidemiological Data [J]. Chinese Journal of Epidemiology, 2024, 45(6): 865-869. DOI: 10.3760/cma.j.cn112338-20231027-00251.