Cynata Therapeutics (ASX:CYP) reports it is collaborating with Leiden University Medical Centre (LUMC) in the Netherlands for a new clinical trial for the company’s Cymerus MSCs drug.
The company says LUMC is funding the clinical trial to investigate Cymerus MSCs as a treatment for renal graft rejection, and to potentially reduce the requirement for anti-rejection drugs.
The clinical trial, titled the Safety and Efficacy of iPSC-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients- the Neried Study will be led by LUMC Head of the Department of Internal Medicine of LUMC Ton Rabelink, and will seek to recruit 10 patients who have undergone a renal transplant.
Cynata expects the trial to commence in 2023, pending the receipt of customary and relevant regulatory, ethics and administrative approvals.
“The potential to enhance survival of transplanted donor organs while at the same time reducing or eliminating the need for damaging anti-rejection drugs would be a substantial breakthrough in transplantation medicine”
Cynata CEO Ross Macdonald said this exciting new collaboration follows very promising clinical trial data with MSCs published by Rabelink and the company’s own published preclinical data in organ transplant rejection.
“The potential to enhance survival of transplanted donor organs while at the same time reducing or eliminating the need for damaging anti-rejection drugs would be a substantial breakthrough in transplantation medicine.
We are delighted to be working with one of Europe’s leading transplant centres and with Professor Rabelink and his team to conduct this important clinical trial.
There is an urgent need for more effective management of immune rejection of donor organs while preserving organ function and minimising side effects of anti-rejection therapy.
From this perspective, MSC therapy is of interest and our own clinical studies have provided strong support for MSC treatment to substantially advance the field of transplantation medicine.
The consistency and potency of Cynata’s unique iPSC-derived Cymerus MSCs make them an ideal candidate for this clinical trial.”
The clinical is an open label, non-randomised, non-blinded, prospective, single centre clinical phase lb study, and it will be conducted in 10 renal allograft recipients aged between 18 and 75.
Following the participant’s transplant surgery, patients will receive a drug used to treat graft rejection and 2 doses of Cymerus MSCs 6 and 7 weeks after transplantation followed by withdrawal of anti-rejection medication.
Cynata reports the end point is safety by assessing absence of acute rejection after withdrawal of anti-rejection medication, and other end points include assessment of renal function at 6 months and the incidence of opportunistic infections.
Cynata Therapeutics is an Australian clinical stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus, a proprietary therapeutic stem cell platform technology.
The company says Cymerus overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.
Its lead product candidate CYP-001 has also met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a phase one trial, and planning for a phase two clinical trial in GvHD under a cleared US FDA IND is presently underway.
Cynata also says clinical trials of Cymerus products in osteoarthritis (phase three) and diabetic foot ulcers (DFU) and currently ongoing, and in addition the company has demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, as well as critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.