Enkai Therapeutics Announces FDA Clearance of IND Application for NK010, China's First Non-Genetically Modified Allogeneic Peripheral Blood NK Cell Therapy

ShanghaiJanuary 18, 2024PR Newswire -- January 17, 2024, Shanghai NK Cell Technology Co., Ltd. (NKCell Therapeutics) independently developed a non-genetically modified natural killer cell injection (project code NK010), which has received Phase I clinical trial (IND) approval from the U.S. Food and Drug Administration (FDA). Currently, this product is China's first non-genetically modified allogeneic peripheral blood NK cell drug to receive FDA approval.

NK010 boasts optimized receptor profiles, diversified targets, high purity, and broad applicability, offering significant advantages in cancer treatment and demonstrating potential for treating multiple types of tumors. NK010 also holds potential for expansion into non-cancer disease treatments and serves as the optimal base cell for a subsequent series of synthetic NK cell drugs (SynNK). The Phase I clinical trial prioritizes ovarian cancer as the initial indication for exploration. Preclinical studies have shown that NK010 cell injections exhibit potent anti-tumor activity in animal models of solid tumors such as ovarian cancer and liver cancer, as well as in acute myeloid leukemia.

According to Professor Tian Zhigang, academician of the Chinese Academy of Engineering and the European Academy of Sciences, and founder of Enkai Cell Medicine, "I am genuinely delighted and proud that the NK010 project has been granted clinical trial approval. At the same time, there is still much for us to explore. Our team has already begun more in-depth research on the next phase of the project to meet urgent clinical needs. Enkai Cell Medicine remains committed to an independent innovation pathway. In the field of NK cell therapy, we have several product pipelines underway, with the hope of bringing more novel therapies to patients worldwide."