Cynata Therapeutics (ASX:CYP) has signed an agreement with WuXi AppTec (NYSE:WX), a leading global biopharmaceutical contract research organisation, to conduct preclinical safety studies with Cynata’s Cymerus™ stem cell technology.
The studies will be conducted at WuXi AppTec’s FDA-registered facility in St Paul, Minnesota.
Cynata’s preclinical program has been designed following an in-depth review of the current regulatory expectations in major jurisdictions worldwide, which has included direct interaction with regulatory authorities.
The data generated from these studies will be a key pillar supporting Cynata’s planned clinical trial program, which is expected to commence next year.
The company expects these safety studies, as part of the broader preclinical program, to facilitate regulatory clearance of its planned clinical trial in graft versus host disease.
The Cymerus™ technology facilitates large scale production of mesenchymal stem cells from a single donor, a key element for pharmaceutical companies as they move into stem cell medicine.
Cynata is developing a therapeutic stem cell platform technology, Cymerus™, which seeks to address a shortcoming in existing methods of production of mesenchymal stem cells 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 precursor, called a mesenchymoangioblast.
The Cymerus™ platform provides a source 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.
In February, Cynata signed a manufacturing agreement with Waisman Biomanufacturing under which Waisman will undertake process development, scale-up and clinical-grade production of Cymerus.
Notably, Dr Kilian Kelly, Cynata's Vice President of Product Development, has held a variety of regulatory and project management positions with Amgen (NASDAQ:AMGN) and AstraZeneca (NYSE:AZN).
AstraZeneca and Amgen are both capitalised at around USD$80 billion.
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