Highlights

• Cynata has received approval for the Phase 1 clinical trial of CYP-001 in kidney transplant recipients.
• CYP-001 is the company’s Cymerus™ iPSC-derived MSC product candidate for intravenous use. Leiden University Medical Centre will manage and fund the trial.

ASX-listed biotechnology company Cynata Therapeutics Limited (ASX: CYP) has received green signal from the competent authority in the Netherlands for its Phase 1 clinical trial of CYP-001 in patients who have received a kidney transplant.

The title of the trial is “Safety and Efficacy of MCA-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients: The Nereid Study”. The trial will be led by Prof Ton Rabelink, head of the division of nephrology and the department of internal medicine and professor of internal medicine at Leiden University Medical Centre (LUMC).

The trial will be funded and managed by LUMC, while CYP will retain commercial rights.

CYP-001 is Cymerus™ iPSC -derived MSC product candidate for intravenous use.

Trial Overview

Under the trial, the company seeks to recruit up to 16 patients who have undergone renal transplantation. The first six patients would receive one or two infusions of CYP-001 along with the standard treatment. If the company gets a favourable safety review in the initial test, then additional 10 patients are planned to get two infusions of CYP-001, followed by tacrolimus dose reduction.

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Prof Rabelink highlighted the problem that the trial aims to solve, stating:

“The side effects from anti-rejection drugs in kidney transplant recipients are a major  problem. Risks include an increased incidence of serious infections and cancer, as well as potential damage to the transplanted kidney. We believe that MSC therapy could help to facilitate dose reduction or even withdrawal of these drugs, which would be a huge step forward in the management of these patients. Cynata’s Cymerus MSCs are of particular interest, due to the consistency and scalability of the iPSC-based platform.”

The trial aims to assess the efficacy and safety of CYP-001 in enabling tacrolimus reduction among patients who have undergone kidney transplantation. Tacrolimus is a calcineurin inhibitor, a kind of immunosuppressant drug utilised to prevent the rejection of transplanted organs.

CYP highlighted that Prof Rabelink and colleagues had published data from a clinical trial in which Mesenchymal Stromal Cell (MSC) therapy was employed in a similar way. The study indicated early tacrolimus withdrawal with MSC therapy safe without increased rejection. The study concluded that this is a potentially effective approach after renal transplantation. 

CYP shares closed the day's trade at AU$0.135 on 21 August 2023.