Sistemic and Cynata announce cooperation on in-process purity assay development for Cell Therapy (CT) product.

Release Date: May 6, 2016

FOR IMMEDIATE RELEASE

Glasgow, Scotland and Victoria, Australia.

Sistemic Ltd. and Cynata Therapeutics Limited (ASX:CYP) announced today that they have entered into an agreement which will see Sistemic use its novel SistemQC™ miRNA technology platforms, together with its extensive internal databases of cellular products to develop an in-process assessment assay for Cynata’s unique Cymerus™ Cell Therapy (CT) products.

  

This follows an extensive period of feasibility assessment where Cynata evaluated the Sistemic technology portfolio and approach.

The development of CT products represents a major breakthrough in the potential to treat a wide range of diseases which are currently untreatable. Nevertheless, the sector has many challenges, not least in terms of standardisation and scale-up. The combination of Sistemic’s predictive miRNA technology, with the standardised and highly scalable technology from Cynata, presents a potential winning combination and paves the way for rapid industrialisation of a wide range of CT products which could revolutionise the way a wide range of diseases are treated.

Jim Reid, Chairman and CEO of Sistemic said “The CT industry holds much promise in so many ways for patients who have untreatable conditions, but the need for standardisation and industrialisation are big challenges the industry has not yet overcome. The combination of the technologies from two of the industry’s leading companies in trying to solve these scalability and reproducibility problems will undoubtedly enhance the speed of clinical development and subsequent uptake into clinical practice. By combining the strength of Sistemic’s technologies and understanding of the biology of cells together with the wide range of attributes of Cynata’s Cymerus technologies we see this collaboration as potentially transformational for the industry as a whole, and would represent a step change in the industrialisation of the sector.”

Kilian Kelly, Vice President, Product Development at Cynata said “Cynata’s unique Cymerus technology delivers a process to manufacture a consistent therapeutic CT product. The development of robust, efficient and sensitive assays is a cornerstone of the development of such a therapeutic product, especially in view of its complex biological nature. Sistemic’s innovative SistemQC™ miRNA has a number of valuable attributes, and we expect this cooperation to help smooth the path forward for our Cymerus clinical development programs.”

Sistemic

Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell and Gene Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell, and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. Furthermore, cell products in the later stages of clinical development benefit from SistemQC™ miRNA-based profiling approach in facilitating patient stratification and monitoring the response to treatment.  In addition, the drug development markets are served through a range of products, which include SistemTOX™, SistemKB™ and SistemRNA™. Sistemic has a worldwide customer base and a strong intellectual property portfolio.

 

For more information contact: press@sistemic.co.uk

Cynata Therapeutics (ASX: CYP)

Cynata Therapeutics Limited (ASX: CYP) is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, Cymerus™, originating from the University of Wisconsin-Madison, a world leader in stem cell research.  The proprietary Cymerus™ technology addresses a critical shortcoming in existing methods of production of mesenchymal stem cells (MSCs) for therapeutic use, which is the ability to achieve economic manufacture at commercial scale.  Cymerus™ does so through the production of a particular type of MSC precursor, called a mesenchymoangioblast (MCA).   The Cymerus™ MCA platform provides a source of MSCs that is independent of donor limitations and provides a potential “off-the-shelf” stem cell platform for therapeutic product use, with a pharmaceutical business model and economies of scale.  This has the potential to create a new standard in the emergent arena of stem cell therapeutics and provides both a unique