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On December 26, a Phase I clinical trial titled "An Open, Single-Arm, Multi-Center Study Evaluating the Safety and Preliminary Efficacy of NK042 Cell Injection (Universal NKR+NK) in Advanced Solid Tumors," conducted by Shanghai Enka Cell Technology Co., Ltd. (Enka Therapeutics), officially commenced. The project will be led by Professor Lin Shen, Director of the Department of Gastrointestinal Oncology and Director of the Phase I Clinical Ward at Beijing Cancer Hospital, whose team is highly renowned in the field of gastrointestinal tumor diagnosis and treatment.NK042 Cell Injection is a universal gene-modified NK cell product independently developed by Enka Therapeutics, derived from allogeneic peripheral blood. It is an off-the-shelf NK cell product that enhances the targeting recognition and killing ability of NK cells through genetic modification. As the first NK cell drug approved for this target in China, NK042 has demonstrated advantages and potential in treating solid tumors, hematological malignancies, autoimmune diseases, aging, and neurodegenerative disorders. The NK042 Cell Injection received clinical tacit approval from China's NMPA in May 2024 and will complete the first patient enrollment and dosing in China soon.At the launch meeting, the participants had in-depth communication and exchange on the study design, observation indicators, enrollment criteria, and research procedures in the clinical trial protocol. They systematically reviewed the matters that should be noted in the study design, fully discussed key issues, and reached a consensus.Academician Tian Zhigang, founder of Enkaicell, stated, "Phase I clinical trials mark the initial stage of new drug development and represent an important milestone in the drug development process. The primary goal is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics of the drug. Currently, the Phase I clinical trial of Enkaicell's NK042 has officially started. We look forward to obtaining high-quality datasets as soon as possible to complete subsequent therapeutic evaluations. We also anticipate that NK042 will bring innovation and breakthroughs to cancer treatment, benefiting patients at an early date. On behalf of Enkaicell, I would like to express my heartfelt gratitude to the researchers, partners, participants, and their families involved in the clinical trials. Your attention, trust, and support have greatly helped us accelerate the R&D process for cancer treatments. Meanwhile, Enkaicell adheres to an independent innovation route. In the field of NK cell therapy, we have several product pipelines underway, hoping to bring more novel therapies to patients worldwide."Professor Shen Lin said, "We look forward to this research opening up more effective new treatment avenues for patients with advanced solid tumors, significantly improving their quality of life and survival expectations. At the same time, we are optimistic about the safety and efficacy of the study drug and are confident in achieving the expected trial results."Shanghai Enkai Cell Technology Co., Ltd. (Enkai Therapeutics) is a biotechnology company focusing on the development of innovative NK cell therapy technologies. Based on over 30 years of the team’s exploration in NK cell fundamental biology, preclinical, and clinical translational research, Enkai Therapeutics is committed to becoming a world-leading cell therapy company with deep expertise in NK cell therapy and its cutting-edge technologies.Enkaicellular Medicine has its exclusive allogeneic peripheral blood NK cell expansion and cryopreservation platform, which supports the clinical "off-the-shelf" grade ABCDE-NK® industrial production system (a single donation can yield trillions of NK cells). Based on the NKR-NKTM technology for mining receptor/ligand targets specific to tumor recognition by NK cells, and through synthetic immunology chassis technologies such as logic-gate genetic circuits (SynNKTM), the company achieves multipotent, intelligent, and controllable gene editing of NK cells. This enables precise targeting of cancer cells, accurate adaptation to the tumor microenvironment, and exact matching of effector/target cells between donors and recipients. In 2024, two NK cell products from Enkaicellular Medicine have successively received clinical trial (IND) approvals from the U.S. FDA and China's CDE.
Source of the article:Enkai Saiyao
