Cynata Therapeutics Limited is an Australian clinical-stage biotechnology company developing disruptive regenerative medicine products.
By using our unique manufacturing platform, Cymerus™, which enables us to economically produce therapeutic mesenchymal stem cells (MSCs) at scale with a consistent quality, we are able to overcome the inherent challenges in first generation methods of manufacturing MSCs for therapeutic use.
We have generated compelling preclinical data in models of a range of different therapeutic indications. We have completed a Phase I clinical study with our lead MSC product candidate, CYP-001, in the treatment of steroid-resistant graft-versus-host-disease (GvHD), a disease with devastating results. Having met all endpoints, the trial results demonstrated excellent safety and efficacy data, which allows us to progress to a Phase II study.
Our partner-centric business model potentially allows us to partner each target disease, maximising our revenue opportunities and ability to leverage the right expertise in the target indication. We have a commercial partnership with the Japanese firm Fujifilm through which Fujifilm has a worldwide exclusive license to our lead product candidate, CYP-001 for GvHD and will finance all product development and commercialisation activities. In addition to paying a US$3m upfront licensing fee in September 2019 the licence agreement includes potential milestone payments of up to US$43m and ultimately ongoing, double-digit royalty payments on sale of CYP-001 product.
We have continued to build on a sound foundation of pre-clinical data in a range of different disease models and have embarked on multiple clinical trials in disease targets such as osteoarthritis and COVID-19 induced respiratory distress, providing a broad and robust clinical development pipeline in areas of high unmet medical need.