Synklino announces publication in American Journal of Transplantation highlighting proof-of-concept for SYN002 in eliminating CMV in human kidneys

• Preclinical data demonstrate >90% reduction in human cytomegalovirus (HCMV) reactivation from latency, establishing proof-of-concept for SYN002 in human kidneys
• Data published in the American Journal of Transplantation and to be presented as a poster at the Cutting Edge of Transplantation (CEoT) Summit, Scottsdale, Arizona, 26–28 February 2026
• Regulatory clearance granted by both UK MHRA and Health Canada for a Phase 1 clinical trial of SYN002, with Canadian study to be conducted independently by Dr. Atul Humar at UHN, Toronto

COPENHAGEN (February 25, 2026) – Synklino A/S, a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention, today announces the publication of a preclinical study in the American Journal of Transplantation. The study titled Inhibition of cytomegalovirus reactivation by ex vivo treatment of human kidneys with the SYN002 immunotoxin is available on open access here.

The preclinical data published in the American Journal of Transplantation will be presented in the form of a poster at the Cutting Edge of Transplantation (CEoT) Summit held in Scottsdale, Arizona, from 26–28 February 2026. 

The poster 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. The data provide compelling proof-of-concept that SYN002 is highly efficacious and safe and that the use of SYN002 in this setting can be expected to provide clinical benefit. In the treated kidneys, reactivation from latency was reduced by >90%, compared with no reduction in the control group.

Ian McGowan, MD PhD, Chief Medical Officer, Synklino, commented: “The publication of these data in the American Journal of Transplantation represents an important validation of our approach. Despite standard of care prophylaxis, approximately 30% of patients who receive a CMV-positive donor organ still experience CMV reactivation. These findings demonstrate that SYN002 has the potential to fundamentally change how CMV is managed in transplantation, by intervening at the donor organ level before transplantation takes place.”

Establishment of the proof-of-concept follows regulatory clearance granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase 1 clinical trial of SYN002 in kidney transplantation. In Canada, Health Canada has granted regulatory clearance for an investigator-sponsored Phase 1 study to be conducted independently by Dr. Atul Humar at the Ajmera Transplant Centre, University Health Network (UHN), Toronto, one of the world's leading transplant centres, with first patient enrolment expected in April 2026.

Thomas Kledal, Chief Executive Officer, Synklino, said: “We are highly encouraged by the preclinical data which establish proof-of-concept for SYN002 in eliminating CMV from donor kidneys prior to transplantation. Following the recent CTA approvals in both the UK and Canada, these data add to our momentum in our mission to advance SYN002 into the clinic and bring a much-needed treatment to kidney transplant patients. This is a pivotal time for us, and we are looking forward to the next major milestones.”