Enkai Therapeutics' NK042 Cell Injection Receives CDE Approval for Clinical Trials in Advanced Solid Tumors

On May 22, the CDE official website showed that Enkaipharma independently developedGenetically Modified Natural Killer Cell Injection (Product Code NK042)Approved by the CDE to conduct clinical trials,For the treatment of advanced solid tumors。

In the NK cell field, Enka Therapeutics has several product pipelines in progress., ItsCore ClinicalPipeline products areIndependently DevelopedIssuedNon-genetically modified (NK010) and genetically modified (NK042)，Both products have successively obtained clinical permits from the U.S. and Chinese drug regulatory authorities, and both possess broad-spectrum application potential.

2024Year1Month17Day, Enke Cell Non-Gene-Modified Natural Killer Cell Injection (Project CodeNK010) Obtain the U.S. Food and Drug Administration (FDA）IPhase Clinical Trial (IND) License,Indications areOvaryCancer. At present, this product is the first in China to obtainFDAApproved Non-Gene-Modified Allogeneic Peripheral BloodNKCellular Medicine.

NK010With optimized receptor spectrum, diversified targets, high purity, and broad applicability, it possesses significant anti-cancer advantages and the potential to treat various types of tumors.NK010There is also potential space for expansion to the treatment of non-tumor diseases, followed by a series of syntheses.NKCellular Medicine (SynNK) The best chassis cell. Preclinical studies have shown that,NK010 cell injection exhibits potent anti-tumor activity in animal models of solid tumors such as ovarian cancer and liver cancer, as well as acute myeloid leukemia.

NK042 is a universal gene-modified NK cell injection derived from allogeneic peripheral blood., with the potential to treat solid tumors, hematological malignancies, and non-cancerous diseases.The indication for this Phase I clinical trial is multiple solid tumors.。The approval of NK042's new drug clinical trial application in China marks the company's transition from the research and development stage to the clinical stage.

About Enke Pharmaceuticals

Shanghai Enka Cell Technology Co., Ltd. (Enka Therapeutics) is a biotechnology company focused on developing innovative technologies for immune cell therapy.Enkai Cell Medicine boasts a unique allogeneic peripheral blood NK cell expansion and cryopreservation platform, capable of producing clinical "off-the-shelf" grade ABCDE-NK® through industrialized production (a single blood donation can yield trillions of NK cells). Based on this, combined with NK cell-specific tumor recognition receptor/ligand target mining technology (NKR-NKTM), and employing synthetic immunology chassis technologies such as logic gate gene circuits (SynNKTM), the company achieves multi-functional, 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.

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