COPENHAGEN (July 24th, 2025) – Synklino A/S, a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention, today announced that its late-breaking abstract has been accepted for an oral presentation at the World Transplant Congress (“WTC”) in San Francisco taking place 2-6 August 2025.
The presentation will include data on the safety and feasibility of the administration of SYN002 to human kidneys during normothermic machine perfusion (NMP), as well as data on the efficacy of eliminating latently infected cells from the treated kidneys.
Treatment with SYN002 was safe with no significant difference in renal perfusate flow, intrarenal resistance, renal tubular injury markers, or histopathology between the treated and control kidneys. In the control group, the levels of reactivation from latency did not decrease after perfusion, whereas in the SYN002 treated kidneys, the reactivation from latency was reduced by 95%.
“We are very pleased with the study results, as they point to the efficient removal of latently infected cells from human kidneys, in a system which is very similar to the setup which will be used in our upcoming clinical trial” said Thomas Kledal, CEO. ”Acceptance of a late-breaking abstract for oral presentation underscores the breakthrough potential of SYN002. Current approaches to CMV prevention cannot reduce the latent CMV reservoir and the development of SYN002 affirms Synklino’s leadership in transforming CMV prevention in the solid organ transplant population” Thomas Kledal added.
Ian McGowan MD PhD, CMO commented “Despite standard of care prophylaxis for CMV, 30% of patients still experience CMV reactivation post-transplantation and are at risk of developing CMV disease. Based on our preclinical data, we believe that kidney perfusion with SYN002 has the potential to significantly reduce the latent reservoir in donor organs and is expected to lead to a significant reduction in CMV reactivation levels and complications from CMV after transplantation.”
About the abstract
- Abstract Title: Ex Vivo Targeting of the Latent Cytomegalovirus Reservoir in Human Kidneys to Prevent Virus Reactivation Post Transplantation
- Session: LOA04 – Late Breaking Studies in Transplant Infectious Diseases
- Session Date & Time: Monday Aug 4, 2025 4:30 PM – 5:45 PM
- Session Type: Late-Breaking Oral Abstract
- Presenter*/Authors: I. M. McGowan*, S. Hosgood, E. Appiah, F.Carlsson, T. Kledal, J. Lantto, M. Nicholson, E. Poole, J. Sinclair
A late-breaking abstract is an abstract that contains new information that was not yet known or fully available by the original abstract submission deadline. The research presented must be novel, innovative, contemporary, and of high scientific significance. Being chosen for an oral presentation rather than a poster signifies that the data is of high quality, broad interest, and considered by reviewers to merit live discussion and prominent visibility.
About Synklino
Synklino is a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention. We aim to build a pipeline by harnessing our proprietary target- identification platform to tailor novel antiviral drug candidates. Our first-in- class breakthrough treatment, SYN002, is a therapeutic fusion protein designed to revolutionize the standard of care prophylaxis for CMV by eliminating both active and latent CMV-infected cells in donated organs through ex vivo organ perfusion, offering a preventative solution for immunocompromised transplant recipients.
Background
Cytomegalovirus (CMV) is the main agent involved in infectious complications following transplant surgery, and a major risk for morbidity and increased hospital readmissions. CMV is a chronic viral infection found in more than 60% of humans worldwide. A healthy individual’s immune system confines the virus to an inactive but persistent state; however, in transplant patients with suppressed immune systems, CMV emerges from latency and significantly impacts morbidity and mortality. CMV increases transplant costs by up to 50% due to long-term hospitalizations and requires difficult courses of treatment. CMV-infected organs constitute a key risk for CMV infection and complications in all transplant recipients at the time of transplantation, regardless of the recipient’s CMV status. No currently marketed or pipeline drugs can cure CMV, and current drugs can be associated with the risk of developing resistance to CMV-therapies.
SYN002 is a therapeutic fusion protein, uniquely targeting both latent and lytic CMV- infected cells. SYN002 is expected to be highly efficacious and potent compared to standard of care antiviral therapeutics which only target active (lytic) infection. Given the compound’s unique mechanism of action, SYN002 has the potential to eliminate the risk of CMV infection in immunocompromised transplant recipients who would otherwise receive a CMV-infected organ. In preclinical studies SYN002 has been shown to be fast-acting with full efficacy anticipated within the few hours that the organ is treated ex vivo (outside the body).
Ex vivo organ perfusion is the treatment of an organ after it has been removed from the donor, and prior to transplantation. Ex vivo organ care has evolved from storage on ice into dynamic reconditioning using machine perfusion. Continuous flushing of donor organs with fluids during machine perfusion allows enhanced preservation with assessment of critical organ function parameters. Organ perfusion enables improvements inf organ function by supplementing blood products or solutions that contain important nutrients, cells, and therapeutics, such as SYN002. Ex vivo machine perfusion increases the number of organs available for transplantation, ultimately improving the chance for a life-saving outcome for patients with end stage renal failure.
For additional information, please contact:
Synklino
Thomas Kledal, CEO
+45 2012 1656
tnk@synklino.com