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2014.06.11 Tokyo Women’s Medical University to Start Phase I and II Clinical Studies for NK Cell Therapy for Malignant Lymphoma

tella, Inc. (Head office: Minato-ku, Tokyo; President and Representative Director: Yuichiro Yazaki) has signed a research outsourcing contract with Tokyo Women's Medical University. Based on this contract, the university will start performing phase I and II clinical studies to determine the safety and efficacy of the NK cell therapy used in combination with rituximab, a molecularly targeted drug, to fight B-cell malignant lymphoma. NK cells are cytotoxic 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 be effective for cancer treatment. However, clinical researches 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. These clinical studies will use the new technology for growing NK cells, for which tella applied for a patent in June 2011. Other technologies reported in research papers have a number of problems. For example, they are unable to increase NK cells sufficiently and even when the number of cells rises more than 1,000 times, the level of cytotoxic activation is low. This technology produces NK cells with cytotoxic activation at a purity of more than 70% while also boosting the number of cells by several thousand times. The resulting improvement in the efficiency of culturing NK cells makes it possible to increase NK cells to a sufficient volume for obtaining clinical results even when using peripheral blood. This will reduce the burden on patients when blood is drawn. In addition, this advance allows growing large numbers of high-purity NK cells even from the peripheral blood of cancer patients with weakened immune systems. By using the results of these clinical studies, tella is aiming to start using the NK cell therapy to treat malignant lymphoma as soon as possible. Furthermore, the mechanism of the NK cell therapy is different than for the dendritic cell (DC) vaccine Vaccell®, for which tella has performed R&D activities. Due to the different mechanisms, these two treatments are expected to be mutually complementary. As a result, combining the two treatments may result in an even more effective method for fighting cancer. tella will continue to perform R&D activities on new immunotherapy using useful 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 2014. Tokyo Women’s Medical University to Start Phase I and II Clinical Studies for NK Cell Therapy for Malignant Lymphoma

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