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What is Cynata’s Cymerus™ Technology?
The Cymerus™ technology is a stem cell manufacturing platform being developed by Cynata Therapeutics Limited (ASX: CYP), an Australian regenerative medicine company. The Cymerus™ technology utilizes induced pluripotent stem cells (iPSCs) originating from an adult donor as the starting material for generating mesenchymoangioblasts (MCAs), and subsequently, for differentiating the cells into mesenchymal stem cells (MSCs).
Therefore, the company is producing iPSC-derived MSCs.
One of the key inventors of Cynata’s Cymerus™ technology is Igor Slukvin, M.D., Ph.D., a world-renowned researcher who has released more than 70 publications about stem cell topics, including the landmark article in Cell describing the now patented Cymerus™ technique. Dr. Slukvin works at the University of Wisconsin-Madison, a global leader in stem cell research. Dr. Slukvin’s co-inventor is James Thomson, the first person to isolate an embryonic stem cell (ESC) and one of the first people to create a human-induced, pluripotent stem cell (hiPSC).
MSCs are currently being explored in nearly 500 clinical trials worldwide, but robust technologies for scaling and standardizing the manufacture of MSCs are scarce. Because Cynata is the only company currently using induced pluripotent stem cells (iPSCs) as starting material for manufacturing therapeutic MSCs, it has the potential to solve the major bottleneck in therapeutic use of MSCs.
For the first time in history, MSCs can be manufactured in unlimited quantities, in uniform batches, from a single donor, and at low cost – a powerful combination of advantages.
What is the Importance of the Cymerus™ Technology?
A short and pithy answer is that the Cymerus™ technology is a long-needed solution to traditional stem cell manufacturing challenges.
The importance of the Cymerus™ technology is that it overcomes major roadblocks that have traditionally limited the therapeutic use of MSCs, which are donor-to-donor variability and the sky-high costs of manufacturing MSC products that rely upon multiple stem cell donors.
According to Cynata Therapeutics, “The proprietary Cymerus™ technology seeks to address 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. 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.”
Importantly, the cost-savings advantages, consistent cellular product, and unlimited production capacity of the Cymerus technology position Cynata as an attractive manufacturing partner for biopharmaceutical companies pursuing MSC clinical trials. In particular, a consistent cellular product is absolutely essential to establishing consistent clinical findings.
What are the Key Advantages of the Cymerus™ Technology?
There are four key advantages of Cynata’s proprietary Cymerus™ MSC manufacturing platform that make it revolutionary. These advantages are:
1. Unlimited Quantities
Cynata’s Cymerus™ technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymoangioblasts (MCAs), and subsequently, for manufacturing clinical-grade MSCs. According to Cynata’s Executive Chairman Stewart Washer who was interviewed by The Life Sciences Report, “The Cymerus™ technology gets around the loss of potency with the unlimited iPS cell—or induced pluripotent stem cell—which is basically immortal.”
2. Uniform Batches
Because the proprietary Cymerus™ technology allows nearly unlimited production of MSCs from a single iPSC donor, there is batch-to-batch uniformity. Utilizing a consistent starting material allows for a standardized cell manufacturing process and a consistent cell therapy product.
3. Single Donor
As described previously, Cynata’s Cymerus™ technology creates iPSC-derived mesenchymoangioblasts (MCAs), which are differentiated into MSCs. Unlike other companies involved with MSC manufacturing, Cynata does not require a constant stream of new donors in order to source fresh stem cells for its cell manufacturing process, nor does it require the massive expansion of MSCs necessitated by reliance on freshly isolated donations.
4. Economic Manufacture at Commercial Scale (Low Cost)
Finally, Cynata has achieved a cost-savings advantage through its unique approach to MSC manufacturing. Its proprietary Cymerus™ technology addresses a critical shortcoming in existing methods of production of MSCs for therapeutic use, which is the ability to achieve economic manufacture at commercial scale.