GenoCare Announces Successful Completion of DLT Observation in First Cohort of Phase I Trial for GKL-006, China's First iNKT Cell Therapy in Pivotal Clinical Stage
Gene Key
Developer of Immune Cell Product Technologies and Provider of Clinical Application Services
Beijing Gene Key Life Technology Co., Ltd. announced that its self-developed GKL-006 injection has achieved significant progress in clinical trials targeting unresectable primary hepatocellular carcinoma. The company has completed the dose-limiting toxicity (DLT) observation phase for the first dose group.And confirmed that no adverse events (AE) related to GKL-006 treatment occurred during this phase., indicating that the drug has demonstrated excellent safety performance, laying a solid foundation for the advancement of subsequent clinical trials.
Beijing Gene Key Life Technology Co., Ltd was established in 2015. It is the world's first leading company to develop a series of iNKT cell pipeline products; it has a biomedical and immunology basic research team, an iNKT cell basic research platform, a clinical research platform, and a large-scale expanded cell culture system.National High-tech Enterprise, a high-tech enterprise in Zhongguan Village, a "Specialized, Precise, Unique, and Innovative" enterprise in Beijing, a technology-based small and medium-sized enterprise, an intellectual property pilot unit, a leading cell industry enterprise in the Zhongguan Village Biomedical Base, and a vice-chairman unit of the Daxing District Science and Technology Association in Beijing,The vice chairman unit of Beijing Specialized, Precise, Unique and Innovative Enterprises Chamber of Commerce, has obtained multiple national and international invention patents, possessing fully independent intellectual property rights over the iNKT cell hyperexpansion platform and unique breakthrough technologies such as exclusive subpopulation distribution.
Major Breakthrough: (1) The world's first completion of safety and efficacy validation for iNKT cell therapy in primary liver cancer; (2) GKL-006 Injection, an innovative iNKT cell product independently developed for the treatment of hepatocellular carcinoma.ObtainClinical Trial Approval (Clinical Trial Notification No.: 2023LP02333) issued by the National Medical Products Administration (NMPA).
China has initially completed the core technology breakthrough and industrial upgrading in the field of iNKT cell therapy, securing a leading position in this area and contributing to the accelerated development of new quality productive forces.
E.N.D
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