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2013.04.16 tella Signs Joint Research Agreement with Kyushu University Agreement marks the beginning of pharmaceutical development activities using the DC vaccine

tella, Inc. (Head office: Chiyoda-ku, Tokyo; President & Representative Director: Yuichiro Yazaki; hereinafter “the Company”) signed a joint research agreement with the National University Corporation Kyushu University (hereinafter “Kyushu University”). In accordance with the agreement, a feasibility study has started concerning the production of cellular pharmaceuticals that use GMP for Investigational Medicinal Products*1 involving the dendritic cell (DC) vaccine. In addition, while working with Kyushu University, the Company will use its Pharmaceutical Planning Office, which was formed on April 1, 2013, to start activities aimed at developing DC vaccine cellular pharmaceuticals.

The Company supplies technologies and know-how related to the DC vaccine therapy*2 to contracted medical institutions. Based on the Medical Practitioners Act and Medical Care Act, these medical institutions offer this therapy as care that is not covered by insurance and as an advanced medical treatment. To enable more cancer patients to receive this treatment with no worries, the Company is starting a program that has the goal of receiving approval of the DC vaccine as a cellular drug. The DC vaccine therapy, which is based on the Company’s technologies and know-how, is offered by using dendritic cell culture technologies at cell processing facilities operated under a strict system to ensure safety. The Company’s aims to achieve even more uniform and stable industrial production in order to supply the DC vaccine as a cellular drug. Accomplishing this will require improving technologies in order to minimize variations in biological activity and in the number of cells for the dendritic cells produced for individual patients, who collectively cover a broad range of physical conditions. To make these improvements, the Company and Kyushu University have jointly developed a cell culture method and submitted a patent application for this technology (patent application no. 2010-112588)*3. This method makes it possible to grow large volumes of dendritic cells from peripheral blood mononuclear cells*4 in a uniform manner along with a sufficient antigen presenting capability*5. Compared with the Company’s current technology, this new approach can produce more than 200 times more DC vaccine along with superior biological activity. Furthermore, using the new technology greatly simplifies the production of dendritic cells compared with the current process. This simplicity will make oversight of the entire production process easier and more reliable.
To perform a feasibility study for the development of cellular pharmaceuticals, this joint research will look closely at the entire DC vaccine production process using high-volume culture technology as well as at quality control and assurance systems. The study uses the viewpoint of compatibility between GMP for Investigational Medicinal Products and the contents of Ensuring Quality and Safety for Drugs and Medical Devices Processed from Human-derived (Autologous) Cells and Tissues (PFSB Notification no. 0208003, February 8, 2008, Director of Pharmaceutical and Food Safety Bureau (PFSB), Ministry of Health, Labour and Welfare).

The objective is to use this joint research to establish a documentary and manufacturing framework that complies with GMP for Investigational Medicinal Products, which is essential for the development of cellular pharmaceuticals. Next, on-site verifications (manufacturing test runs) will be performed for all production processes.

The Company is committed to making an even greater contribution to the care of cancer patients by continuing to utilize its technologies and know-how for R&D activities involving the DC vaccine. This matter will have only a negligible effect on results of operations in fiscal 2013.