Takara Bio Inc. (President & CEO: Ikunoshin Kato, Ph.D.) entered into a Clinical Supply Agreement with the National Cancer Institute (NCI) in the U.S. to supply Takara Bio's RetroNectin^® required for clinical studies of T-Cell Receptor (TCR) gene therapy using anti-MART-1 TCR and anti-gp100 TCR. These NCI-sponsored studies conducted by Steven A. Rosenberg, MD., Ph.D., Chief of Surgery Branch at NCI will recruit about sixty metastatic melanoma patients.

Dr. Rosenberg, a pioneer of adoptive immunotherapy, has been conducting anti-cancer therapy with Tumor-Infiltrating Lymphocytes (TIL) transduced with the gene encoding IL-2. During the course of therapy, TIL, which can destroy cancer cells, are collected from cancer patients and transduced with the IL-2 gene through RetroNectin^®-facilitated gene-transfer. After ex vivo expansion, the TIL are then infused into cancer patients.

In these new protocols, TIL or Peripheral Blood Lymphocytes (PBL) are taken from metastatic melanoma patients. TCR genes which recognize melanoma tumor antigens are then transduced into the TIL or PBL with the assistance of RetroNectin^®. Followed by expansion of transduced lymphocytes, cancer patients receive the infusion of these lymphocytes. The gene-transduced lymphocytes express TCR which recognizes tumor antigen peptides, and to specifically attack the cancer cells.

In this form of adoptive immunotherapy, genes encoding TCR recognizing many tumor antigens can be transduced into TIL and PBL. This technique is, highly experimental. Takara Bio expects RetroNectin^® to be useful in studies of gene therapy as well as in cancer immunotherapy.

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.

For more information:
Corporate Communications
Takara Bio Inc.
E-mail: bio-ir@takara-bio.co.jp

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

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