Establishment of Joint Research Chair by Takeda and Osaka University

Osaka, Japan, January 6, 2012 – Osaka University and Takeda Pharmaceutical Company Limited (“Takeda”) announced today their agreement on the establishment of a Joint Research Chair for 3 years to develop a platform for the practical application and commercialization of vaccines using hydrophobic poly (γ-glutamic acid) (γ-PGA) nano-particles^*1 (“nano-particles”) as adjuvant^*2.

The Joint Research Chair at Osaka University is academic-industry collaboration research program, through which the university and external institutions such as business enterprises perform joint research to achieve outstanding results. They aim to bring results to society by expanding them to a new industry. The program was established in April 2006. Currently, more than 20 programs have been launched in advanced scientific areas including biotechnology.

Takeda launched the Vaccine Business Division on January 1, 2012, which pursues opportunity ranging from enhancing vaccine pipelines through in-licensing innovative vaccines and establishing new technology platform, to geographical expansion of the vaccine business outside of Japan. The Joint Research Chair established at Osaka University as part of Takeda’s vaccine strategy, will contribute to further develop innovative technology in Takeda R&D including CMC research^*3.

In the Joint Research Chair program, bridging research aiming for practical application and commercialization of nano-particle containing vaccines will be conducted, combining the fundamental technology of nano-particles developed by Osaka University, and Takeda’s know-how on vaccine antigens, research and development platform, drug formulation technology, quality control/standardization, and patent administration. To be precise, research for the practical application and commercialization of next-generation adjuvant will be performed, advancing the technology research on the characteristics of nano-particles as an adjuvant.

“The fundamental research at JST-CREST^*4 (Japan Science and Technology Agency—Core Research for Evolutional Science and Technology) has already demonstrated that nano-particles are able to efficiently carry vaccine antigens, actively deliver antigens to dendritic cells, which are antigen-presenting cells, and hence provide a beneficial effect of immune induction,” said Mitsuru Akashi, Professor of the Osaka University Graduate School of Engineering and the research leader of this Joint Research Chair. “We will advance the research for practical application of the technology, such as prevention of infectious disease, by combining the fundamental technology of Osaka University with the clinical studies, development, and formulation technology of Takeda.”

“We are attempting to develop diverse pipelines by establishing new platform technology that allows the discovery of innovative vaccines and also maximizes the value of existing vaccines,” said Tetsuo Miwa, General Manager of the CMC Center at Takeda. “We will promote the research and development of new vaccine adjuvants by combining the advanced nanotechnology of Osaka University with our formulation technology and know-how of quality control.”

^*1 γ-PGA is a poly-amino acid synthesized by bacteria (Bacillus) , with the molecular weight ranging from hundreds of thousands to millions. It is a water-soluble biodegradable polymer that can be synthesized in large quantities, and is available for various chemical modifications. Transferring hydrophobic amino acids to the γ-PGA while controlling the amphiphilic structure produces nano-particles with high dispersion stability. Hydrophobic γ-PGA nano-particles are characterized by efficiently and stably holding antigen proteins inside or on the surface of the particle.

^*2 An adjuvant is a substance to enhance an immunological response to a vaccine antigen administered with such an adjuvant. The actions include the sustained-release of antigens, promotion of cellular uptake, and activation of immune cells.

^*3 CMC stands for chemistry, manufacturing and controls, which is the research and development activities including the design of API or formulation and product quality, and the development of manufacture processes to put new drug candidates discovered through research onto the market.

^*4 JST-CREST is one of the Strategic Basic Research Programs promoted by Japan Science and Technology Agency. CREST (Core Research for Evolution Science and Technology) is a funding program for team-based basic researchers. Its priority research objectives are called “Strategic Sectors” and researchers are aiming to discover innovation seeds that are expected to have substantial impact on our economy and lives.

[Reference: Concept of nano-particle vaccine]

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