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2015.03.17 An Exclusive License Received for Immune Cell Cryopreservation Solution,a Key Technology for Regenerative and Cell Medicine,in a Step Toward Vaccell® Regulatory Approval

tella, Inc. (Head office: Minato-ku, Tokyo; President & Representative Director: Yuichiro Yazaki) hasreceived the exclusive license for the manufacture and sale of a cryopreservation solution for immune cells. This is a key technology for regenerative and cell medicine.
tella will transfer this license to subsidiary Tella Pharma Inc., which aims to create a practical use for this cryopreservation solution for the transport of the dendritic cell vaccine Vaccell®note. The goal is to speed up preparations for the receipt of regulatory approval for this vaccine by submitting a clinical trial notification by the end of 2015.
This technology (patent pending), for which we received the exclusive standard utilization license, makes it possible to use freezing for the stable, long-term storage of cells with a high survival rate and retention of the functions of immune cells. When freezing immune cells for storage, there is a risk of damaging cells due to the crystallization that occurs during the freezing process. Avoiding this problem requires the use of a preservation solution that does not crystallize when frozen. Normally, a substance called dimethyl sulfoxide (DMSO), which is toxic to the cells and people, is included in the preservation solution for this purpose. As a result, there was a need for either aseptic cleansing or dilution of the solution so that the DMSO concentration falls below the toxicity level. But this new technology’s preservation solution enables freezing and storing cells with even greater safety while using no DMSO. Furthermore, the cell survival rate is higher. In a test using the dendritic cell vaccine Vaccell®, the cryopreservation cell survival rate after thawing was higher than for a preservation solution containing DMSO. In addition, cytotoxic T-cells retained sufficient inducibility. 
tella established Tella Pharma in January 2014 to perform activities required to receive regulatory approval for the dendritic cell vaccine Vaccell®. This company plans to operate a centralized cell processing facility that uses cells received from patients for the production of a dendritic cell vaccine that will then be sent to medical institutions, where these patients are examined, and be directly administrated to them. To provide this service, Tella Pharma will require a freezing method for the reliable storage and transport of these cells. This method must preserve the functions of dendritic cells for a long time with no degradation compared with the level of effectiveness prior to freezing. Using this new technology will permit the transport and long-term storage of dendritic cells while retaining their functions. Another advantage is elimination of the need for equipment to remove DMSO. These benefits greatly shorten processing time and make it easier to treat patients.
In the future, tella’s client medical institutions may be allowed to use this preservation solution for transporting the dendritic cell vaccine Vaccell®. This would probably contribute to more growth in the number of contracted medical institutions. Furthermore, tella is considering selling this technology to medical institutions, research institutes, companies and other organizations for the cryopreservation and transport of tissue and cells for clinical trials. There is also potential for using this technology for clinical trials using induced pluripotent stem (iPS) cells and other substances for regenerative medicine, treating infertility and other applications.
tella is committed to contributing to progress in the treatment of cancer by continuing to take the actions needed to receive regulatory approval for the dendritic cell vaccine Vaccell®. This matter will have only a negligible effect on results of operations in fiscal 2015.

Note: Dendritic cell vaccine Vaccell®
This new cancer immunotherapy involves the production outside the patient’s body of a large volume of dendritic cells (a special type of cell that is a key regulator of the immune system and capable of activating lymphocytes that defend the body from foreign substances), which normally exist in only small quantities in the blood. These cells are then processed so that they recognize the patient’s cancerous tissues and substances (cancer antigens) produced artificially as a tumor marker. Next, the cells are returned to the patient’s body so that the characteristics of the cancer are transferred from the dendritic cells to lymphocytes. The lymphocytes can then attack only the cancer cells. tella is currently working on receiving approval for the dendritic cell vaccine Vaccell® under Japan’s Pharmaceuticals and Medical Devices Act as a regenerative medicine product for the treating cancer.

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