- Patient dosing commenced in world-first Phase I trial of stem cell therapy CYP-001 in graft-versus-host disease; recruiting at six centres in the UK and Australia
- Secured $60-million-plus FUJIFILM partnership and license option for CYP-001 in GvHD
- Raised additional $10 million: $4 million equity investment from FUJIFILM and $6 million placement
- Reported positive pre-clinical data in heart attack and asthma; expanded pre-clinical pipeline to acute respiratory distress syndrome
- Filed two new patent applications with IP Australia to expand opportunities in cancer immunotherapy
- Completed pre-Investigational New Drug meeting with U.S. Food and Drug Administration Office of Cellular, Tissue and Gene Therapy; written recommendation expected by July 2017
In the context of cell therapy, product innovation is the introduction of a cellular product that is new or has significantly improved characteristics or intended uses. Over the past decade, a great deal of attention has been given to cell therapy product innovation, as demonstrated by the thousands of cell therapy products that have now entered clinical trials worldwide.
In contrast, process innovation refers to the implementation of a new or significantly improved production or delivery method. In the context of cell therapy, process innovation has received much less attention from the marketplace. [Read more…]
In breaking news released earlier this month, Cynata Therapeutics (ASX: CYP) announced a major world first. The company treated a patient with steroid resistant acute graft-versus-host disease (GvHD) as part of a phase 1 clinical study of its first mesenchymal stem cell (MSC) product, CYP-001 .
This is an important value catalyst for Cynata and also for the regenerative medicine industry, because it is the first time ever that a patient has been treated with an allogeneic induced pluripotent stem cell (iPSC)-derived therapeutic mesenchymal stem cell (MSC) product.
Cynata and FUJIFILM Sign Development and Commercialisation Partnership Agreement
- Fujifilm takes A$3.97 million strategic equity stake in Cynata
- Parties to collaborate on the further development and commercialisation of Cynata’s lead Cymerus™ therapeutic MSC product CYP-001 for graft-versus-host disease (GvHD)
- Potential future upfront and milestone payments in excess of A$60 million
- Double-digit royalties on CYP-001 product net sales
- Strategic relationship for potential future manufacture of CYP-001 and certain rights to other Cynata technology
For years, it has been clear that mesenchymal stem cells (MSCs) are a leading type of stem cell being investigated for therapeutic applications, as they have the potential to treat a wide range of acute and degenerative diseases. In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-inflammatory and anti-fibrotic.
MSCs are also advantageous over other stem cells types, because they avoid the ethical issues that surround embryonic stem cell research and appear to be immuno-privileged. Importantly, MSCs also well-suited for use in the exponential growth area of 3D printing, because of their unusual capacity to form structural tissues. [Read more…]