Synklino announces proof-of-concept for SYN002 in eliminating CMV in human kidneys

Data published in the American Journal of Transplantation and to be presented at the Cutting Edge of Transplantation Summit

Published on Feb. 25, 2026

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Synklino, a Danish biotechnology company, has announced the publication of a preclinical study in the American Journal of Transplantation, demonstrating that their drug candidate SYN002 can effectively eliminate human cytomegalovirus (HCMV) reactivation from latency in human kidneys by over 90% compared to control. The company has also received regulatory clearance from the UK MHRA and Health Canada to conduct Phase 1 clinical trials of SYN002 in kidney transplantation, with the Canadian study to be led by Dr. Atul Humar at the University Health Network in Toronto.

Why it matters

CMV is a major risk factor for morbidity and increased hospital readmissions in transplant patients with suppressed immune systems. Current drugs can be associated with the risk of developing resistance, and no marketed or pipeline drugs can cure CMV. SYN002's unique mechanism of action targeting both latent and lytic CMV-infected cells has the potential to eliminate the risk of CMV infection in immunocompromised transplant recipients.

The details

The preclinical data showed that the administration of SYN002 to human kidneys during normothermic machine perfusion (NMP) was safe and effective, reducing reactivation from latency by over 90% compared to control. 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.

  • The preclinical data will be presented as a poster at the Cutting Edge of Transplantation (CEoT) Summit held in Scottsdale, Arizona, from 26–28 February 2026.
  • The first patient enrollment for the Phase 1 clinical trial of SYN002 in Canada is expected in April 2026.

The players

Synklino

A Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention.

SYN002

Synklino's first-in-class breakthrough drug candidate, a therapeutic fusion protein designed to eliminate both active and latent CMV infection in donated organs through ex vivo organ perfusion.

Dr. Atul Humar

A leading transplant specialist who will independently conduct the Phase 1 clinical trial of SYN002 in Canada at the Ajmera Transplant Centre, University Health Network (UHN), Toronto.

Ian McGowan

The Chief Medical Officer of Synklino.

Thomas Kledal

The Chief Executive Officer of Synklino.

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What they’re saying

“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.”

— Ian McGowan, Chief Medical Officer, Synklino

“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.”

— Thomas Kledal, Chief Executive Officer, Synklino

What’s next

The first patient enrollment for the Phase 1 clinical trial of SYN002 in Canada is expected in April 2026.

The takeaway

SYN002's unique mechanism of action targeting both latent and lytic CMV-infected cells has the potential to eliminate the risk of CMV infection in immunocompromised transplant recipients, addressing a major unmet need in kidney transplantation.