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Click the poster for more detailsAugust 27, 2024
eMedClub News
On August 26, Beijing Gene Key Life Technology Co., Ltd. ("Gene Key" for short) announced that the second Investigational New Drug (IND) application for its "GKL-006 Injection" had been recently approved by the National Medical Products Administration (NMPA). The indication is for the prevention of high-risk recurrence in patients with primary hepatocellular carcinoma after radical resection.
Gene Key Life Technology Co., Ltd. stated that GKL-006 injection has beenSignificant progress has been made in clinical trials for 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 excellent safety performance of the drug and laying a solid foundation for the advancement of subsequent clinical trials.
Liver cancer is the fourth most frequently occurring cancer in China and has the second highest mortality rate among all cancers. Liver cancer is divided into primary liver cancer and secondary liver metastasis, which is caused by the spread of lesions from other sites. Primary liver cancer originates in the liver tissue, among which...The most common type is hepatocellular carcinoma (HCC), which accounts for approximately 90% of all primary liver cancers.The risk factors for hepatocellular carcinoma mainly include hepatitis B and C, alcohol consumption, and obesity, among others.Due to the high prevalence of hepatitis B in some parts of China, the number of new cases of liver cancer in China remains high. In 2020, there were more than 379,000 new patients with hepatocellular carcinoma in China.The five-year survival rate is only 12.1%., significantly lower than the overall five-year survival rate of 40.5% for cancer in China. The main reason for the low five-year survival rate is the complexity of its pathogenesis and the current lack of clear drug targets, as well as the absence of effective treatment methods. These factors indicate that the incidence and corresponding treatment of liver cancer are facing severe challenges. Meanwhile, the unmet clinical needs will become the main driving force for the development of the liver cancer drug market.GKL-006 Injection is an adoptive immune cell candidate drug independently developed and produced by Beijing Gene Key Life Technology Co., Ltd., with a clear mechanism of action, and its component is iNKT cells.iNKT Cells, namely Invariant Natural Killer T Cells (iNKT)iNKT cells develop in the thymus, accumulate in the liver, and are secondarily distributed in the spleen, bone marrow, lymph nodes, skin mucosa, and peripheral blood, among other sites. In peripheral blood, iNKT cells account for approximately 0.01-0.1% of circulating T cells. Despite their scarcity and limited origin, the potential application of iNKT cells in tumor immunotherapy is increasingly prominent.
iNKT Cells and Their Anti-Tumor EffectsiNKT cells can simultaneously activate both the innate and adaptive immune systems, and activate antigen-specific CD8+ T cells and NK cells., while targeting both MHC-positive and MHC-negative tumor cells,Overcoming the Immune Escape Mechanism Caused by MHC Downregulation in Tumor CellsTherefore, theoretically, iNKT cells can eliminate cells that have produced tumor antigens and those that have not, or newly emerging variant tumor cells, thereby potentially suppressing tumor progression, metastasis, and recurrence.This is the second IND approval for the GKL-006 injection. In November 2023, the GKL-006 injectionFirst IND Application for Unresectable Primary Liver Cancer Indication Receives CDE Clinical Tacit Approval, which is also the world's first iNKT cell candidate drug for liver cancer to be approved for clinical trials, is currently undergoing clinical trials.Beijing Gene Key Life Technology Co., Ltd was founded 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 cell culture system for expansion. A national high-tech enterprise, it is a leading cell industry company in the Zhongguancun Biomedical Base. It has obtained multiple national and international invention patents and owns fully independent intellectual property rights for its iNKT cell overexpansion platform and unique subpopulation distribution and other breakthrough technologies.References:
1.Gene Key
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