In major news released today, Australian stem cell company Cynata Therapeutics announced that it has begun the manufacturing process for CYP-oo1, an iPSC-derived mesenchymal stem cell product. CYP-001 is anticipated to be the world’s first allogeneic iPSC product to enter a clinical trial.
The company also announced that it has filed a further patent application that could give Cynata additional commercial exclusivity protection in key markets worldwide.
To learn more, read the full press release issued by Cynata Therapeutics, printed with permission from Cynata CEO Ross Macdonald.
Cynata Commences Manufacture of Clinical Trial Product; Files Further Patent Application
• Commencement of manufacture of CYP-001 product supplies for upcoming clinical trial
• Follows series of successful manufacturing qualification runs
• Further patent protection for proprietary CymerusTM mesenchymal stem cell (MSC) technology
Melbourne, Australia; 5 May 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that its contract manufacturer in the USA, Waisman Biomanufacturing, has commenced manufacture of supplies of CYP-001 product for specific use in the clinical trial in graft-versus-host disease (GvHD), expected to commence within the next few months.
Manufacture of the clinical trial batch of CYP-001 was initiated following the successful conclusion of a lengthy and intensive series of good manufacturing practice (GMP) manufacturing qualification runs. These qualification runs were conducted multiple times over the course of the past year in a rigorous program which determined that product of consistent, high quality could be derived using the Company’s unique Cymerus process.
The Company also announced that it had filed a further patent application describing certain novel aspects of the Cymerus technology. This patent application is owned by Cynata and, should it mature to a granted patent, will provide additional commercial exclusivity in key markets around the world. The new discovery will add further value to the Cymerus technology that clears a path toward low cost, cutting edge MSC therapy.
“The production of the clinical trial batch of CYP-001 is a very important step for Cynata. It follows the major achievement last year of transferring the original laboratory process to Waisman and upscaling it in a GMP environment. The product derived from the qualification runs has provided abundant material for the pre-clinical program that has been underway for around 12 months; now we will complete that phase with the manufacture of our clinical trial batch”, said Dr Kilian Kelly, Cynata’s Vice President of Product Development.
CYP-001 is Cynata’s lead therapeutic product, an allogeneic, induced pluripotent stem cell (iPSC)-derived MSC. Cynata plans to undertake a Phase 1 clinical trial with CYP-001 in graft-versus-host disease (GvHD) before undertaking development for further disease targets, ideally in collaboration with commercial partners.
About 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 differentiator and an important competitive position.
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