Cynata Therapeutics Expands Its Clinical Horizons with Approval for a New Kidney Transplant Trial (ASX:CYP)

21st August 2023 | Healthcare & Biotech News | StockHound

Melbourne-based Cynata Therapeutics Limited, a pioneering clinical-stage biotechnology company centered on cell therapeutics, has secured approval from the Centrale Commissie Mensgebonden Onderzoek (CCMO), the Netherlands’ regulatory authority, to initiate a Phase 1 clinical trial. This trial, set to focus on the application of CYP-001 in kidney transplant patients, represents a promising evolution in the world of transplant medicine.

CYP-001, a star product of Cynata, is distinguished by its origin from the innovative Cymerus™ iPSC-induced MSC platform. Notably, the financial and managerial reins of this trial have been handed over to the Leiden University Medical Centre (LUMC), with Cynata entrusted with supplying the vital CYP-001. Significantly, Cynata retains all commercial rights concerning CYP-001.

The trial, named “Safety and Efficacy of MCA-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients: The Nereid Study”, will be steered by Prof. Ton Rabelink. As the Professor of Internal Medicine and the Head of both the Division of Nephrology and the Department of Internal Medicine at LUMC, Rabelink’s expertise is invaluable. His role in the Regenerative Medicine route of the Dutch Science Agenda further underlines his esteemed position in the field.

Rabelink shed light on the profound implications of this study, emphasizing the complications kidney transplant recipients often face from anti-rejection drugs. These include heightened risks like grave infections, potential cancer, and even the peril of harming the newly transplanted kidney. He is hopeful that the MSC therapy will revolutionize the treatment protocol, possibly even eliminating the need for such high-risk drugs. He highlighted the unique consistency and scalability of Cynata’s iPSC-based platform, lending it particular interest in this endeavor.

The trial’s primary objective delves into the safety and potential of CYP-001 in mitigating the dependence on tacrolimus post-kidney transplantation. As an immunosuppressant, tacrolimus plays a pivotal role in thwarting organ rejection. Rabelink’s previous studies already hint at the prospects, with data suggesting the safety of early tacrolimus withdrawal coupled with MSC therapy. The results presented a reduced rejection rate, marking a significant stride in post-renal transplantation care.

The trial’s design seeks to enlist 16 kidney transplant patients, with the first six candidates slated to receive one or two infusions of CYP-001, integrated with standard treatment protocols. Provided the initial phase passes safety evaluations, the following ten patients will be treated with two CYP-001 infusions, supplemented by a reduced tacrolimus dose.

Dr. Kilian Kelly, Cynata’s CEO and Managing Director, expressed his elation at the regulatory nod, viewing this as a monumental addition to Cynata’s extensive repertoire in transplant medicine. He lauded Prof. Rabelink and his team’s illustrious record in kidney transplantation research, particularly their prior breakthroughs with MSCs, and anticipated a fruitful collaboration in this trailblazing project.

Cynata Therapeutics stands at the forefront of stem cell and regenerative medicine, with its proprietary Cymerus™ therapeutic stem cell technology. By leveraging induced pluripotent stem cells (iPSCs) and mesenchymoangioblast (MCA), the platform offers the cost-effective production of cell therapy products at a commercial scale, eliminating the challenges posed by multiple donors. The company’s flagship product, CYP-001, has previously exhibited positive outcomes in the treatment of steroid-resistant acute graft-versus-host disease in a Phase 1 trial. The company’s expanding clinical landscape now encompasses trials in graft-versus-host disease, osteoarthritis, and diabetic foot ulcers, as well as preclinical investigations into diseases like asthma, heart attack, and sepsis.