Takara Bio to enter into an M-CRADA with Dr. Rosenberg's group at NCI initiating pre-clinical studies of gene therapy using RetroNectin^®-expansion culture system

January 9, 2008 --- Takara Bio Inc. (President and CEO: Ikunoshin Kato, Ph.D.) has entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with National Cancer Institute in the U.S. under which Dr. Steven A. Rosenberg's group at NCI conducts pre-clinical studies utilizing Takara Bio's proprietary RetroNectin^®-expansion culture system to analyze its utility for gene therapy.

Dr. Rosenberg has been known for his pioneer work in the field of cancer immunotherapy, and his team recently achieved good results demonstrating sustained regression of malignant melanoma in patients treated with TCR-gene therapy, which was published in Science journal in 2006.

Under the M-CRADA, RetroNectin^® is provided to NCI by Takara Bio for Dr. Rosenberg's pre-clinical studies to determine its effect on ex vivo culture of gene modified human T cells.

About RetroNectin^®-expansion culture system

RetroNectin^®, the company's proprietary recombinant human fibronectin, has been widely used for retroviral gene therapy protocols as it significantly enhances retrovirus-mediated gene transfer to blood cells.

An alternative application of RetroNectin^® we recently discovered is its use in T-cell expansion. Our study demonstrates that T cells stimulated in vitro on immobilized RetroNectin^® in the presence of anti-CD3 monoclonal antibody can be expanded approximately 250-fold by culturing for 10 days, and more importantly, they contain higher numbers of cells with phenotype of naive T cells compared to those expanded without RetroNectin^®.

It has been demonstrated that naive T cells, that is in an immature stage of T-cell differentiation, are more active in mediating tumor regression than T cells with a more differentiated phenotype. Thus, T-cells expanded with RetroNectin^® containing higher portion of naive T cells are expected to have more potential to kill tumors, while T cells expanded only with anti-CD3 antibody by conventional method show differentiated phenotypes with less activity to attack tumors.

[ About Takara Bio Inc. ]

Takara Bio Inc. is an innovative biotechnology company based in Shiga, Japan. As a world leader in biotechnology research and development, Takara Bio was the first company to market PCR technology in Japan and is also the developer of the RetroNectin^® reagent, which is a world-standard in gene therapy protocols. In addition to providing research reagents and equipment to the life science research market, Takara Bio has active research and product development activities in the fields of gene and cell-based therapy, and agricultural biotechnology; and is committed preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, the Company aims to extend its reach around the world. More information is available at http://www.takara-bio.com.

This article is translated from press release in Japanese for your convenience.

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