Regeneus and Cryosite partner for the development and manufacture of human stem cell products

Thursday, 21 August 2014

Regeneus (ASX: RGS) and Cryosite (ASX: CTE) announced today that they have signed an agreement to collaborate on the development and manufacture of new stem cell products for human applications.

Key elements of the agreement include:

  • Regeneus will provide technology, know-how and research facilities to assist Cryosite with the development of methods for the expansion of cord tissue-derived mesenchymal stem cells (MSCs);
  • Cryosite will provide production facilities for Regeneus’ off-the-shelf allogeneic stem cell product for human osteoarthritis (Progenza). The product, to be used for clinical trial purposes, will be manufactured within Cryosite’s good manufacturing practice (GMP) clean room facilities by Regeneus staff; and
  • The companies will jointly explore new product development and manufacturing opportunities

Cryosite’s Acting CEO, Graeme Moore, said: “There are a number of synergies between our two companies that we are focused on bringing to commercial fruition. The agreement has a direct and immediate effect on increasing Cryosite’s revenues and will enable the further development of a new cord tissue derived stem cell product that will complement our established cord blood stem cell banking service. Cord tissue contains MSCs that are not generally found in cord blood”.

Professor Graham Vesey, Regeneus CEO, stated that: “This agreement allows Regeneus to cost effectively fast-track the production of Regeneus’ off-the shelf Progenza product for preclinical and clinical trials for market entry into Japan”.

Progenza is Regeneus’ off-the-shelf stem cell product for human OA that is manufactured by collecting a small amount of fat from a human donor. The stem cells from the fat are expanded by tissue culture, dispensed into vials and frozen. Several hundred thousand doses of the product can be produced from fat from one donor thus allowing a true pharmaceutical industry style stem cell product.

Professor Vesey also stated: “Our relationship with Cryosite is developing into a strong partnership and we anticipate that it will continue to grow over time. Cryosite currently provides stem cell handling and storage services for Regeneus’ personalised stem cell therapy for human OA, HiQCell. Cryosite’s capabilities in the manufacturing and storage of GMP cell-based products in a TGA licensed facility complements Regeneus’ product development and early stage commercialisation capabilities. We foresee a future where our two companies use these capabilities together to develop and supply a range of regenerative medicine products”.