Cynata Therapeutics, the Australian stem cell and regenerative medicine company that is developing the therapeutic stem cell platform technology Cymerus™, has inked a deal with WuXi AppTec, a world leading biopharmaceutical contract research organisation, to conduct stem cell studies.
According to the ASX announcement by Cynata Therapeutics, under the terms of the agreement, the preclinical safety studies will be conducted with Cynata’s unique Cymerus™ stem cell technology at WuXi AppTec’s GLP-compliant, FDA-registered facility in St Paul, Minnesota.
The Cymerus™ technology facilitates large scale production of MSCs from a single donor, a key element for pharmaceutical companies as they move into stem cell medicine.
“We are very pleased to have engaged an organisation as proficient and well regarded as WuXi AppTec to conduct these vital studies,” said Dr Kilian Kelly, Cynata’s Vice President, Product Development.
“The team of scientists that will run this project has extensive experience conducting similar studies with other cellular therapy products, which gives us confidence that our program will be conducted to the highest standards. We expect these safety studies, as part of the broader preclinical program, to facilitate regulatory clearance of our planned clinical trial in graft versus host disease”.
Cynata’s preclinical program has been designed on the basis of an elaborate review of the current regulatory expectations in major jurisdictions in the world.
The proprietary Cymerus™ technology has been developed to overcome the key shortcoming in current methods of production of mesenchymal stem cells (MSCs) for therapeutic use – the ability to achieve economic manufacture at commercial scale.
This is achieved with the production of the 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 differentiator and an important competitive position,” it says in the ASX announcement by Cynata.
The clinical trial is set to commence in 2015.
The company signed a manufacturing agreement with Waisman Biomanufacturing in February. Under the terms of this agreement, Waisman will conduct process development, scale-up and clinical-grade production of the Cymerus technology.