Cynata Therapeutics

Cymerus™ Platform

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Frank Ruhl Libre

The trademark Cymerus refers to the patented process of deriving highly potent and consistent mesenchymal stromal cells (MSCs) from induced pluripotent stem cells (iPSCs). This technology was originally developed at the University of Wisconsin-Madison (UWM), a world-renowned leader in stem cell research. Cymerus™ overcomes the trade-off between scale and consistency that other MSC technologies lack. 

Cynata is using this powerful technology to develop new medicines, including in indications with large expected volumes. 

First generation methods of MSC production rely on isolation of MSCs from tissue donations, for example bone marrow or fat. This approach is associated with a number of important limitations, including:

The relative scarcity of MSCs in adult tissue

The low proliferative capacity of adult stem cells

Loss of potency and reduced efficacy associated with extensive MSC culture expansion (in an effort to maximise the number of MSCs from each donation)

In the Cymerus™ process, iPSCs can proliferate indefinitely, and the unique precursors  themselves can expand into extremely large quantities of MSCs.

Cynata expects to be able to manufacture all of the cells that it will ever need from a single "master cell bank" of iPSCs – derived from a single donor.

Consequently, the 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 without requiring multiple donors or excessive culture expansion of the derived MSCs. This opens up a wide range of therapeutic and manufacturing possibilities for the Company.

As cells mature, they become less and less “expandable”. Therefore, MSCs derived from primary tissue sources such as bone marrow have a limited expansion capacity, meaning that manufacturers constantly need to be identifying and screening new cell donors. This is an expensive and time-consuming process. Cynata manufactures its MSCs  using induced pluripotent cells (iPSCs) as a starting material. Pluripotent cells have effectively infinite expansion capacity. 

Consequently, Cynata expects to be able to source all of the cells it will ever need from a single donor. Furthermore, it means that Cynata does not need to excessively expand MSCs in culture in order to produce large numbers of doses. This is important, as excessive culture expansion has been shown to result in adverse changes in the functionality of MSCs, limiting their therapeutic potential. The Cymerus™ process has the potential for great efficiencies of scale. 

It is well-established in the scientific literature that batches of MSCs produced from different donors have substantially different properties, which is likely to result in unpredictable and inconsistent clinical efficacy. Conversely, the Cymerus™ process achieves batch-to-batch consistency, which is expected to increase the predictability of clinical outcomes.

MSCs are immunoprivileged, meaning that they can generally be infused or injected into recipients without provoking a significant adverse immune response. However, antibodies to injected MSCs derived from tissue donations have been detected in some clinical trials. One reason for this may be the presence of non-immunoprivileged contaminating cells, left over from the process of extracting and purifying cells from donor tissue, which contains a wide variety of different cell types. Cynata’s cells are manufactured from iPSCs, rather than being purified from primary tissue sources such as bone marrow and adipose tissue. Consequently, the level of purity of Cynata’s cell products is high, which translates into a lower likelihood of stimulating an immune response in the recipient.