Australian stem cell company Cynata Therapeutics is preparing to test its iPSC-derived cell therapeutic, CYP 004, in a Led by the University of Sydney and funded by the Australian Government National Health and Medical Research Council (NHMRC), the historic trial will assess whether Cynata’s cell therapeutic, CYP-004, has the capacity to improve patient outcomes in osteoarthritis (OA).CYP-004 is an allogeneic, iPSC-derived mesenchymal stem cell (MSC) product derived using Cynata’s proprietary Cymerus™ technology.Cynata’s Cymerus™ technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymoangioblasts (MCAs). They are not intended to diagnose, treat, cure or prevent any disease or condition. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine. Annual report for the financial year ended . 30 June 2018 . We look forward to advancing our Cymerus MSCs into Phase 2 trials for GvHD and other indications.”The significance of Cynata’s latest safety and efficacy data is that it will support the advancement of additional Cymerus™ MSC product candidates directly to Phase 2 trials in other indications.
The company has established the safety of its Cymerus™ iPSC- derived MSCs and demonstrated preclinical efficacy in a humanized animal model. It then differentiates these cells into mesenchymal stem cells (MSCs). Based on the In addition to its potential windfall from Fujifilm related to completion of its Phase I trial, Cynata Therapeutics achieved a financial victory related to its Phase II trial program. Because Cynata is using iPSCs as its starting material for manufacturing therapeutic MSCs, it has the potential to solve a bottleneck in the therapeutic use of MSCs.For the first time in history, Cynata’s is able to manufacture MSCs in unlimited quantities, in uniform batches, from a single donor, and at low cost – a powerful combination of advantages. Board of Directors . Australian stem cell company Cynata Therapeutics has completed the world’s first Phase I trial involving an induced pluripotent stem cell (iPSC) derived therapeutic product. It occurs when the cushion or cartilage between the joints starts to break down, leading to swelling, stiffness, and pain.With the Phase II OA trial anticipated to commence in the second half of 2019, funding will be supplied by NHMRC and other participating institutions, requiring no cash contribution from Cynata. This has already been demonstrated and is widely documented. That is a salient achievement for researchers, clinicians, corporates and patients alike.On August 30, 2018, Cynata Therapeutics announced the completion of the Primary Evaluation Period for all 15 patients enrolled in its Phase 1 clinical trial of CYP-001, including patients from both Cohort A and Cohort B.As highlighted in Cynata’s press announcement, CYP-001 Most importantly for the patients in the trial, their families and caregivers, 14 out of 15 patients showed an improvement in GvHD severity by at least one grade compared to baseline. If you have a health condition or concern, consult your physician or health care provider.Cynata Completes Phase I Trial for CYP-001, Triggers Option Window for Fujifilm If you have a health condition or concern, consult your physician or health care provider.Cynata’s iPSC-derived Cell Therapeutic (CYP-001) Meets Safety & Efficacy Endpoints I had the honor of interviewing Dr Ross Macdonald, CEO of Cynata Therapeutics. Cynata Therapeutics Ltd (ASX: CYP) is a relatively young stem cell and regenerative medicine company. The Company previously announced (8 May 2020) that the trial sponsor, the University of Sydney, intended to utilise the Clinical Trial Exemption (CTX) clinical trial approval route for this trial. An Australian stem cell and regenerative medicine company The trademark Cymerus refers to the patented process of generating cell-based products from intermediate cells, known as mesenchymoangioblasts (MCAs), which in turn are derived from induced pluripotent stem cells (iPSCs). Dr Paul Wotton Non-Executive Chairman. Host Disease) in bone marrow transplant patients. Cymerus™ overcomes the challenges of other stem cell production methods by using iPSCs and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of therapeutic MSC products at commercial scale and without the requirement for multiple donors.For the first time in history, this approach enables the industrial-scale manufacture of therapeutic MSCs and the ability to leverage a platform technology across a range of therapeutic applications, an exciting phenomenon which we are now seeing materialize.In additional news, Wall Street biotech analyst Dr Raghuram Selvaraju of H.C. Wainwright & Co published a further research update on Cynata. This event triggers for Fujifilm a 90-day window in which to exercise its license option for CYP-001.If Fujifilm exercises this license option, it will issue Cynata Therapeutics a USD $3 million payment, as well as move the product toward milestones that could reach AUD$60 million, plus potential double-digit royalties on product sales.With a market cap of U.S. $16.3B, Fujifilm is the global behemoth within the regenerative medicine space. Cynata has released a Clinical Study Report (CSR) for its historic Phase I trial to its strategic partner and equity stake holder, Fujifilm. By 2015, CDI was acquired by Fujifilm, who as mentioned above, is a major shareholder in Cynata and its strategic partner.Cynata’s proprietary stem cell manufacturing platform is known as its Cymerus™ technology.