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2013.08.06 Technology for culturing NK cells developed jointly with Kyushu University reported in Human Gene Therapy Methods -tella establishes technology for culturing ZNK® cells that are highly effective in killing cancer cells

tella, Inc. (Head office: Chiyoda-ku, Tokyo; President and Representative Director: Yuichiro Yazaki;hereinafter “the Company”) has been performing joint development with the National University Corporation Kyushu University (Kyushu University) concerning natural killer cells (NK cells), which we call ZNK® cells, that are highly effective killing cancer cells. A patent application was submitted in February 2012. An English-language research paper about the technology for culturing ZNK® cells was published in the electronic version of the July 25, 2013 Human Gene Therapy Methods. This is the official publication of the European Society of Gene and Cell Therapy, International Society for Cell and Gene Therapy of Cancer, the British Society for Gene and Cell Therapy and 10 other international academic associations.

NK cells are cytotoxic and pure human natural killer cells that can kill virus infection cells and cancer cells. The cells are believed to help prevent diseases. In people with advanced cancer, there are declines in the number and activity of NK cells. As a result, there were hopes that culturing and invigorating NK cells outside the body would make cell immunotherapy more effective. However, clinical studies performed mainly in Europe and the United States have been unable to achieve a sufficient increase in NK cells and their activation outside the body. This prevented the cells from being highly effective at killing tumors. Scientists worldwide have been seeking a method to overcome this problem. This announcement involves a new technology for which the Company and Kyushu University jointly submitted a patent application in February 2012. The new technology optimizes to a high degree several important parameters. Using this method makes it possible to use human mononuclear cells from peripheral blood cells to produce hundreds of times more NK cells with the greatest possible cytotoxicity and a very high purity. Almost 100% of the ZNK® cells cultured using this technology produce CD69 which is a lymphocytic cell activation marker. Furthermore, the ZNK® cells contain several times to 10 times more perforin and granzyme B, which are the cell killing molecules, than before culturing. Based on the cancer cell (K562 cell) used as the standard marker for NK cell activation, tests have shown that ZNK® cells can kill almost all cancer cells at a ratio of one ZNK® cell for each cancer cell. Moreover, this process requires only about two hours. Compared with culturing methods that have already been announced, this new technology has an outstanding cell killing activity. The technology can also multiply the number of NK cells several hundred times. This breakthrough raises expectations for the creation of a practical ZNK® cell immunotherapy method that is even more effective at treating cancer.

he Company will continue to perform R&D activities involving helpful cells including ZNK® cells. The goal is to give the large number of cancer patients more treatment options.

This matter will have only a negligible effect on results of operations in fiscal 2013.

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