SYN002 / Synklino - LARVOL DELTA

Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission: A Pilot Safety Trial in Kidney Transplant Recipients (RESPECT-CMV) (ATC 2026) - "RESPECT-CMV is the first-in-human clinical study evaluating targeted elimination of latent CMV within donor kidneys via ex vivo therapy. By addressing the latent reservoir directly within the graft, SYN002 may prevent CMV transmission and reactivation post-transplant while avoiding systemic antiviral toxicity. This novel approach has potential to redefine CMV prevention strategies in solid-organ transplantation."

First-in-human • Preclinical • Cytomegalovirus Infection • Solid Organ Transplantation • Transplantation

RESPECT-CMV: Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: University Health Network, Toronto

New P1 trial • Cytomegalovirus Infection • Infectious Disease • Transplantation

Inhibition of cytomegalovirus reactivation by ex vivo treatment of human kidneys with the SYN002 immunotoxin. (PubMed, Am J Transplant) - "SYN002 treatment during NMP appeared safe and reduced HCMV levels in cells isolated from kidney perfusates. The study provides compelling proof-of-concept that SYN002 is efficacious and safe and that the use of SYN002 in this setting can be expected to provide clinical benefit."

Journal • Preclinical • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

Ex Vivo Targeting of the Latent Cytomegalovirus Reservoir in Human Kidneys to Prevent Virus Reactivation Post Transplantation (WTC 2025) - "Treatment for CMV during NMP appeared safe and reduced the foci of infection in cells isolated from the perfusate. The ex vivo 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. SYN002 constitutes a novel approach for the prevention of transplantation associated CMV reactivation and disease without the need for antiviral prophylaxis."

Late-breaking abstract • Post-transplantation • Preclinical • Cytomegalovirus Infection • Immunology • Infectious Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation • FABP1 • IGFBP7 • TIMP2