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. [Read more…]