Enkay Therapeutics Launches China's First Clinical Trial of Universal Gene-Modified NK Cell Therapy NK042 for Advanced Solid Tumors

Dec 27, 2024 10:21 CST Updated 10:21

NK CellTech

Immune Cell Therapy Developer

December 26, 2024, Shanghai Enke Cell Technology Co., Ltd. (Enke Pharmaceuticals) a “EvaluationPrice NK042 Cell Injection (Universal Type)NKR+NK) An open, single-arm, multi-center Phase I clinical study on the safety and preliminary efficacy in advanced solid tumors”Clinical Trial Officially Launched. This project will be carried out byProfessor Lin Shen, Director of the Department of Gastrointestinal Oncology and Director of the Phase I Clinical Ward at Beijing Cancer Hospital, The team enjoys a high reputation in the field of diagnosis and treatment of digestive system tumors.

NK042 Cell InjectionIs an allogeneic peripheral blood-derived product independently developed by Enkaichem.Universal Gene-Modified NK Cell Product, isA universal off-the-shelf NK cell product with enhanced targeting recognition and killing ability through genetic modification, forThe First NK Cell Drug Targeting This Site Approved in China, demonstrating advantages and potential in treating solid tumors, hematological malignancies, autoimmune diseases, aging, and neurodegenerative disorders. NK042 cell injection received clinical trial approval from China's NMPA in May 2024 and will complete the first patient dosing in China soon.

At the launch meeting, the attendees respectivelyFor the clinical trial protocolStudy Design, Observation Indicators, Inclusion Criteria, Research Processetc.Conducted in-depth communication and exchange, systematically reviewed the matters that should be noted in the research design, fully discussed key issues, and reached consensus.

Academician Tian Zhigang, Founder of EnkaicellPhase I clinical trials are the starting stage in the process of new drug development and also an important milestone in the drug development process. The main purpose is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics of the drug. Currently, Enkaiceph...NK042 IPeriodThe clinical trial has officially started. We look forward to obtaining a high-quality dataset as soon as possible to complete the subsequent treatment evaluation. We also anticipate that NK042 will bring innovation and breakthroughs to cancer treatment, benefiting patients earlier. Here, on behalf of Enka Therapeutics, I express my heartfelt gratitude to the researchers, partners, subjects involved in the study, and their families for their attention, trust, and support, which have greatly helped us accelerate the R&D process of cancer treatment. Meanwhile, Enka Therapeutics adheres to an independent R&D 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 Lin Shen"We look forward to this research opening up a more effective new treatment pathway for patients with advanced solid tumors, significantly improving their quality of life and survival expectations. At the same time, we hold a positive attitude towards the safety and efficacy of the study drug and are confident in achieving the expected trial results."

Exterior of Enka Saiya Company

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 basic 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.

Enkaisai Medicine possesses exclusive allogeneic peripheral blood NK cell expansion and cryopreservation technology, with clinical "off-the-shelf" grade ABCDE-NK.^®Industrial production platform (a single blood supply can produce trillions of NK cells), based on the technology for mining receptor/ligand targets specific to NK cell tumor recognition (NKR-NK).^TM) as the support, through synthetic immunology chassis technologies such as logic gate gene circuits (SynNK^TM), achieving multipotent, intelligent, and controllable gene editing of NK cells, enabling them to precisely target cancer cells, accurately adapt to the tumor microenvironment, and precisely match the effector/target cells of donors and recipients. In 2024, two NK cell products from Enka Therapeutics have successively received clinical trial (IND) approval from the U.S. FDA and China's CDE.

Enkai Cell Medicine will focus on solving the treatment challenges of major clinical diseases (such as cancer, autoimmune diseases, aging and degenerative diseases, immunodeficiency and related diseases), with the goal of achieving precise immunotherapy. It has developed a series of original intelligent NK cell products, striving to build an immune cell drug company that continuously breaks through core technologies and maintains international leadership, and aims to become the birthplace of a new generation of NK cell therapy technologies and products worldwide.

E.N.D

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Disclaimer: The content is sourced from Enka Therapeutics' official channels. This article aims to share knowledge, and all content is for reference only, not constituting any advice.