Otsu/Shiga, Japan – September 17, 2013 – Takara Bio Inc. announced today that it has entered into a contract service agreement with Japanese Ministry of Economy, Trade and Industry (“METI”), following the public announcement by METI on August 12, 2013 that Takara Bio’s two promising regenerative medicine products (MAGE-A4 antigen-specific T- cell receptor (TCR) gene modified lymphocytes and HSV-TK gene modified lymphocytes) had each been selected as one of METI’s new projects for FY2014 that are part of its “Project to Promote the Industrialization of Regenerative Medicine”.
As one of the most important strategies for future economic growth in Japan, the Japanese government is instituting a wide range of measures to support development in regenerative medicine. In particular, the purpose of METI’s “Project to Promote the Industrialization of Regenerative Medicine” is to develop evaluation methods related to safety or other elements that will be essential for commercialization of regenerative medicine products; the marketing of which is expected to expand rapidly in the near future.
Under the agreement, Takara Bio will receive a government subsidy to support two gene therapy projects: MAGE-A4 antigen-specific TCR gene therapy and HSV-TK gene therapy. Through these two projects, Takara Bio aims to establish safety and efficacy assessments to meet the evolving needs of advancing regenerative medicine. Furthermore, Takara Bio will develop evaluation methods to prove bioequivalence in the event of a change of raw materials or manufacturing process by technical renovation or innovation.
The outline of the agreement is as follows;
Consigner: Japanese Ministry of Economy, Trade and Industry
Term: from September 12, 2013 to March 31, 2014
Sponsored Grant: 94 million yen (including TAX)
Project Purpose: relating to the two kinds of gene modified T lymphocytes that Takara Bio has developed (MAGE-A4 TCR modified T lymphocytes and HSV-TK modified T lymphocytes):
1) To establish the efficacy and safety assessments and specification required for approval of regenerative medicine products;
2) To establish evaluation methods to prove bioequivalence in the event of change of raw materials such as media component, biological components etc; and
3) To establish evaluation methods to prove bioequivalence in the event of change of manufacturing process.
Takara Bio is currently preparing to commence a Phase I clinical trial for treating solid tumors using MAGE-A4 antigen-specific TCR gene therapy before March 2014. In the case of the HSV-TK gene therapy project, Takara Bio aims to start a joint Phase I clinical trial for hematological malignancy in Japan and South Korea in FY 2016.
[ 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 including functional food and mushroom production businesses; 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.