NK CellTech Announces FDA Clearance for Clinical Trial of NK010

SHANGHAI, Jan. 22, 2024 /PRNewswire/ — On January 17, 2024, NK CellTech Co., Ltd. (NK CellTech), a leading biotech company focused on the development of NK cellular therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of NK010, the non-genetically modified natural killer cells. 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.

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."

About NK CellTech Co., Ltd. (NK CellTech)

NK CellTech Co., Ltd. (NK CellTech) is a leading biotech company dedicated to the discovery and development of innovative technology of NK cell therapy. The R&D team has over 30 years of experiences in the research and clinical practice of NK cells, which dedicates NK CellTech to become an international leading company in cellular immunotherapy.

NK CellTech has a unique ABCDE-NK® industrial production platform featuring our unique technologies of feeder-free large scale expansion and high efficiency gene modification of PBMC-NK cells, cryopreservation provide "off-the-shelf" supply for clinical immediate use. Through the synthetic immunological technology platform (SynNK) such as the logic gates, NK CellTech has fulfilled the intelligent editing of NK cells so that they are precisely targeted to tumor cells, precisely adopted to tumor microenvironment, and precisely matched between the donor and recipient. NK CellTech has successfully developed a series of innovative intelligent NK cell pipeline products, and remains steadfast in its mission to revolutionize cancer treatment through precision cellular therapies and fulfill the unmet clinical needs.

Forward-looking statement：

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," (collectively referred to as "forward-looking statements") and describe opinions about possible future events. These statements are subject to significant risks and uncertainties. The reader is cautioned not to rely on these forward-looking statements, for they are based on management’s current expectations and beliefs of future events as of this date. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors which are beyond the Company’s control and which may cause the actual results, performance or achievements of the Company to be materially different from those expressed or forecast in the forward-looking statements. Factors that could cause actual results to be materially different from those reflected in the forward-looking statements include but are not limited to (i) risks associated with our business or market competition; (ii) effects of changes in politics, economies, laws, regulations or policies.

Therefore, neither the Company nor any employee shall assume obligation to update these forward-looking statements, or undertake any obligation if actual results differ materially from those anticipated in the forward-looking statements.

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