On January 22, 2024 NK CellTech Co., Ltd. (NK CellTech), a leading biotech company focused on the development of NK cellular therapies, reported that the FDA has granted clearance for the clinical trial of NK010, the non-genetically modified natural killer cells (Press release, NK CellTech, JAN 22, 2024, View Source [SID1234639416]). NK010 is the first non-genetically modified NK cells expended from allogeneic peripheral blood cell (PBMC) approved for clinical trial by the FDA from China.

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NK010 exhibits multiple high anti-tumor advantages including wide spectrum and high expression of NK cell activation receptors and high purity, which makes it possible to treat variety types of tumors. NK010 also shows the potential to treat non-tumor diseases and can be the best basal cell for a subsequent series of synthetic NK cell drugs (SynNK) developed by the company. The ovarian cancer was the first indication chosen for exploration in this Phase I clinical trial. Pre-clinical studies have shown outstanding potential, with NK010 exhibiting strong tumor growth inhibition on ovarian cancers in animal models, liver cancer and other solid tumors as well as acute myeloid leukemia.

"We are thrilled and proud to receive FDA clearance for the clinical trial of NK010," said Professor Zhigang Tian, Founder of NK CellTech and member of the Chinse Academy of Engineering and the Academia Europaea. "NK010 has demonstrated promising anti-tumor activity and safety in preclinical studies. We have great confidence in its potential to treat solid tumors. Yet, there is still a lot left to explore, and our team has remained on our mission to revolutionize cancer treatment through innovative cellular therapies and fulfill the unmet clinical needs in the future."