Aussie clinical stage biotech company Cynata Therapeutics (ASX: CYP) has marked a milestone in its Phase 2 clinical trial of CYP-001 for high-risk acute graft versus host disease (aGvHD) with the enrolment and treatment of its first patient.
High-risk acute graft versus host disease (aGvHD) is a serious complication that can occur after a stem cell or bone marrow transplant. In this condition, the donor’s immune cells (graft) attack the recipient’s healthy tissues (host), leading to various health issues. This immune response, known as graft-versus-host disease (GvHD), can cause significant damage to the body and requires prompt medical attention. It is typically treated with steroids, but the outcomes are often unfavourable.
Cynata’s trial focuses on evaluating stem cells as a solution, with its CYP-001, Cynata’s Cymerus™ off-the-shelf iPSC-derived MSC product candidate, as a potential immune modulating treatment for aGvHD. This product has shown decent safety and efficacy results in a prior Phase 1 trial for steroid-resistant aGvHD and has received clearance from the US FDA for Investigational New Drug (IND) application and Orphan Drug Designation.
Cynata’s Chief Executive Officer, Dr Kilian Kelly, said, “The treatment of the first patient in this Phase 2 trial marks a milestone moment in the clinical development journey of CYP-001 for aGVHD. We are continuing to open additional clinical centres, and we anticipate completion of enrolment by the end of this calendar year, with primary results available in the second half of 2025.”
Cynata Therapeutics is an Australian company focused on stem cell and regenerative medicine, leveraging its proprietary Cymerus™ technology to overcome production challenges and achieve economic manufacture of cell therapy products. This technology utilises induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to produce mesenchymal stem cells (MSCs) at commercial scale.
The Phase 2 trial aims to enroll approximately 60 patients with high-risk aGvHD, who will be randomised to receive either steroids plus CYP-001 or steroids plus placebo. Approval for the trial has been granted in Australia, the USA and Turkey, with recruitment ongoing across multiple clinical centers. The first patient was enrolled in the USA.
In addition to its progress in aGvHD treatment, Cynata Therapeutics has made advancements in other research areas. Initial analysis of its Phase 1 trial for CYP-006TK in diabetic foot ulcers showed promising results, with a median percentage reduction in wound surface area of 87.6% in the active group compared to 51.1% in the control group.
Financially, in H1 FY24, the Company reported a 41.3% increase on H1 FY23 in revenue to $2.5 million and a 12.2% improvement in losses to $4.5 million. Moreover, Cynata Therapeutics appointed Dr. Mathias Kroll as Chief Business Officer, effective mid-April, to further drive its growth in the biopharmaceutical sector.
The World Economic Forum dubbed stem cells as the “medical innovation of the century”. As Cynata progresses with its regenerative medicine use-cases across a range of illnesses, the promise of stem cells becomes just that more evident and achievable.
Alinda is a Business Reporter for The Sentiment
Latest posts by Alinda Gupta (see all)
- Ovanti’s iSentric signs contracts worth $14.4m with Malaysian commercial bank - June 27, 2024
- Baby Bunting fights back from retail downturn with 5-year strategy, includes Gen-Z focus and self-funded growth - June 27, 2024
- CLEO meets with US FDA to develop strategy for ovarian cancer test launch - June 26, 2024
Leave a Comment
You must be logged in to post a comment.