Cynata Therapeutics (ASX: CYP) has executed a term sheet with FUJIFILM Corporation of Japan for the development and commercialisation of certain Cynata technology, including Cynata’s lead product, CYP-001. CYP-001 is an induced pluripotent stem cell (iPSC) derived mesenchymal stem cell (MSC) product that is anticipated to be the first allogeneic iPSC product to enter a clinical trial.
Australian stem cell company Cynata Therapeutics announced that it has filed an application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase I clinical trial for its lead product, CYP-001. CYP-001 is an iPSC-derived mesenchymal stem cell product that is anticipated to be the world’s first allogeneic iPSC product to enter a clinical trial.
To learn more, read the full press release issued by Cynata Therapeutics, printed with permission from Cynata CEO, Dr. Macdonald. [Read more…]
I am honored to release this interview with Dr. Paul Wotton, who joined Cynata Therapeutics Board of Directors in June, 2016. He was previously President and CEO of Ocata Therapeutics, Inc. (NASDAQ: OCAT) joining the company in July 2014 and managing it through an all-cash take-over by Astellas Pharma valued at $379 million. Prior to Ocata, Dr. Wotton had served as President and CEO of Antares Pharma Inc. (NASDAQ: ATRS), since October, 2008. Prior to joining Antares, Dr. Wotton was the CEO of Topigen Pharmaceuticals and prior to Topigen, he was the Global Head of Business Development of SkyePharma PLC.
Dr. Wotton is also a member of the board of Vericel Corporation, an American company developing autologous cellular therapies and also past Chairman of the Emerging Companies Advisory Board of BIOTEC Canada. Dr. Wotton received his Ph.D. in pharmaceutical sciences from the University of Nottingham and an MBA from Kingston Business School.
Enjoy Dr. Wotton’s insights in his interview below. [Read more…]
Australian stem cell company Cynata Therapeutics announced that it plans to file an application for regulatory approval within the UK to initiate a Phase 1 clinical trial of its iPSC-derived MSC product CYP-001 in July 2016.
This is a significant announcement, because it will be the world’s first allogeneic iPSC clinical trial.
Cynata’s Cymerus™ technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymoangioblast (MCAs), and subsequently, for differentiating the cells into mesenchymal stem cells (MSCs). The outcome is that Cynata can produce MSCs in unlimited quantities, in uniform batches, from a single donor, and at low cost. The company’s lead product produced using the s Cymerus™ technology is CYP-001.
This clinical trial will also be the first time that the company’s unique Cymerus technology is tested in humans.
Based in Glasgow, UK, Sistemic Ltd. is a company that specializes in microRNA-based services and kit-based products. Cynata Therapeutics is a stem cell and regenerative medicine company listed on the Australian stock exchange (ASX: CYP).
Cynata’s Cymerus™ technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymal stem cells (MSCs). The importance of this technology is that it is a process for manufacturing a consistent cell therapy product.
Cynata’s lead product is CYP-oo1, an iPSC-derived mesenchymal stem cell product that is anticipated to be the world’s first allogeneic iPSC product to enter a clinical trial.
In the press release below, Sistemic Ltd. and Cynata Therapeutics announce that they have entered into an agreement in which Sistemic will use its miRNA technology platforms to develop an in-process assessment assay for Cynata’s Cymerus™ cell therapy products.
MSCs are currently being explored in nearly 500 clinical trials worldwide, but technologies supporting large-scale manufacturing of MSCs are scare, which is what makes standardization and scale-up of the Cymerus technology important.
To learn more, read the full press release issued by Sistemic Ltd. below. [Read more…]