OREANDA-NEWS. September 06, 2016. FUJIFILM Corporation (President: Kenji Sukeno) has reached a basic agreement* with the Australian regenerative medicine venture, Cynata Therapeutics Limited (hereinafter “Cynata”), to invest 3 million U.S. dollars in the company. Following the signing of a formal contract, Fujifilm will receive the third-party allocation of Cynata's new shares to acquire slightly over 10% of Cynata's total number of shares issued.

Through the third-party share allocation, Fujifilm will have an option to acquire the development, manufacturing and sales licensing rights as well as contract manufacturing rights for the regenerative medicine product using allogeneic iPS cell-derived mesenchymal stem cells**, for which Cynata plans to carry out clinical trial on graft versus host disease(GvHD)*** patients. The agreement also allows Fujifilm to access Cynata's technologies and know-how for developing regenerative medicine products using allogeneic iPS cell-derived mesenchymal stem cells.

Cynata is licensed to use the differentiation and induction technologies of the University of Wisconsin, which has a top-level technology concerning iPS cells and the company has already established technology for efficiently mass-producing allogeneic iPS cell-derived mesenchymal stem cells. It is currently preparing for clinical trial of a regenerative medicine product using allogeneic iPS cell-derived mesenchymal stem cells, after acceptance of the British MHRA (Medicines and Healthcare Products Regulatory Agency)*4 with excellent results of the product's pre-clinical trials. The full clinical trial on GvHD patients is due to start in Britain at around the end of this year. It will use allogeneic iPS cells supplied by the Fujifilm subsidiary and leading company in iPS cell development and manufacturing, Cellular Dynamics International, Inc. (hereinafter “CDI”) based in the United States.
The clinical trial on the regenerative medicine product using allogeneic iPS cell-derived mesenchymal stem cells will start ahead of the rest of the world. Through investing in Cynata, Fujifilm will acquire cutting-edge technologies and know-how to accelerate its R&D on regenerative medicine products.

Through CDI, Fujifilm is undertaking R&D of iPS cell-based cell therapies for age-related macular degeneration, Parkinson's disease and heart diseases. In the field of age-related macular degeneration, CDI is undertaking joint R&D with the National Eye Institute (hereinafter “NEI”) of the U.S. National Institute of Health*5. In January 2017, NEI plans to start clinical trial, using autologous iPS cell-derived cells supplied by CDI. The joint research and development with NEI, using allogeneic iPS cell-derived cells, is also in progress.

Fujifilm will work to make further progress in research and development in the field of regenerative medicine and contribute to the elevation of regenerative medicine business to the industrial stage. Fujifilm will continue to fuse its expertise in highly functional materials and engineering nurtured through long-years of research in photographic film with the technologies held by Fujifilm group companies, such as the technology of Japan Tissue Engineering Co., Ltd., for producing cells for treatment and the world-leading iPS cell-related technology and know-how developed by CDI.

  • * This basic agreement is based on a non-binding term sheet and subject to change until a formal contract is signed.
  • ** Mesenchymal stem cells are in vivo stem cells that have a certain level of differentiation / multiplication ability. They have been subject to clinical research on over 1,000 cases for the treatments for various disease of including cerebral infarction, cartilage injury, ischemic heart failure and limb ischemia,GvHD. They are expected to provide versatile efficacies and have their high level of safety verified.
  • *** GvHD stands for graft-versus-host disease, in which the graft recognizes the body of the recipient (the host) as “foreign.” GvHD is a generic term for complications involving a donor organ attacking the recipient's organs in an immune response.
  • *4 Britain's regulatory authority for pharmaceuticals and medical products, established under the Department of Health. It is responsible for approving pharmaceuticals and medical equipment.
  • *5 A medical research institute belonging to the U.S. Public Health Service, Department of Health and Human Services

A regenerative medicine venture developing cell therapy (anti-GvHD drug) using allogeneic iPS cell-derived mesenchymal stem cells

  • Company name: Cynata Therapeutics Limited
  • Managing Director and CEO: Dr. Ross Macdonald
  • Address: Suite 1, 1233 High Street Armadale, Victoria 3143, Australia
  • Year of establishment: 2013
  • Paid-in capital: 28.8 million Australian dollars
  • Business description: Research and development of regenerative medicine products