Takara Bio Inc. (President and CEO: Ikunoshin Kato, Ph.D.) entered into a material transfer agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in the U.S. to supply Takara Bio's RetroNectin^® for the use in MSKCC's phase I clinical trial of chronic lymphocytic leukemia (CLL), which is being conducted by Renier Brentjens, M.D., Ph.D. et al.
CLL is a disorder of morphologically mature but immunologically less mature lymphocytes and is manifested by progressive accumulation of these cells in the blood, bone marrow, and lymphatic tissues. The disease is most commonly diagnosed middle-aged and elder people. The incidence of CLL is said to be 1-3 out of 100,000, and approximately 7,000 new cases of CLL are diagnosed in the U.S. annually. Since detailed mechanisms of CLL development remain unclear and the fact that the disease remains incurable, novel treatment methods for this disease are required.

In this protocol, lymphocytes (T cells) collected from CLL patients are retrovirally transduced in vitro by utilizing RetroNectin^® method with a gene encoding chimeric antigen receptor (CAR)*, which specifically recognizes the CD19 antigen expressed on malignant lymphocytes (B cells). Following expansion of transduced lymphocytes in the laboratory, CLL patients will be infused with these modified lymphocytes. The gene-transduced lymphocytes express the CD19-specific CAR which recognize CD19 antigen of malignant lymphocytes, and accordingly they attack the malignant lymphocytes. This phase I trial will enroll approximately 30 CLL patients who have shown refractory symptoms with current chemotherapy, and will take 2-3 years to complete.

We are happy to announce that this is the 40th clinical study which utilizes our RetroNectin^® in the preparation of the gene transduced lymphocytes. Through this agreement with MSKCC, we expect that our RetroNectin^® material will be recognized and utilized more and more as a standard technology for ex vivo gene therapy.

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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