- SYN002 close to entering phase 1 clinical development
- Changes in the Board of Directors
Copenhagen October 11th, 2024 – Synklino, a Danish biotech company developing drugs to treat chronic viral infections, has decided to focus the development of SYN002 on eliminating CMV in infected organs prior to transplantation (ex vivo).
As a result of previous Series A investment, Synklino now have:
- GLP tox data supporting the above-mentioned ex vivo therapy
- SYN002 GMP drug product to supply clinical development
- Pre-clinical efficacy data from human organs
- Regulatory alignment with DKMA (Danish Medicines Agency)
Thorough toxicology studies led us to focus on advancing SYN002 as an ex vivo therapy, while we are continuing our work to establish a path for in vivo therapy with SYN002.
Synklino is on the verge of entering clinical development with SYN002. Thus, we now aim to raise capital to conduct a phase 1 clinical trial on CMV-infected organs before transplanting them into patients. The aim of the trial is to generate safety and efficacy data and building a solid foundation for expanding the Company’s pipeline.
Thomas Kledal, co-founder and Chief Executive Officer said: “Our focus on bringing SYN002 into clinical development in an ex vivo setting is a result of our significant pre-clinical program, which is now coming to an end. Our data support this path into the clinic, as also endorsed by clinical leaders and regulatory authorities.”
The full CMV transplantation market consists of the ex vivo market i.e., treatment of organs and the larger in vivo market.
The pivot towards the ex vivo market has led the institutional investors Maj Invest, Eir Ventures and EIFO and a few non-institutional shareholders to fully exit Synklino. On this background, Synklino’s board of Directors will be trimmed.
For Synklino, the ex vivo market opportunity is strategically fitting the properties of SYN002 and constitutes an attractive segment of the full CMV transplantation market.
Background information
CMV is the main agent involved in infectious complications following transplantation, with major risk for morbidity and increased hospital readmissions and is prevalent in around 60% of adults.
SYN002 is a fusion protein, uniquely targeting both latent and lytic CMV infected cells. SYN002 is expected to be highly efficacious and potent on the lytic infected cells, also compared with standard of care antiviral therapeutics, and given the compound’s unique mechanism of action, SYN002 has the potential to eliminate the risk of CMV infection and reactivation in immunocompromised transplant recipient. SYN002 is fast acting with full efficacy anticipated within the few hours that the organ is treated ex vivo (outside the body) while preparing it for transplantation.
Ex vivo organ therapy is the treatment of an organ after it has been removed from the donor, and prior to transplantation. The organ is flushed (perfused), treated and tested to optimize it for transplantation. Ex vivo perfusion was initially introduced to preserve donor organs until transplantation into the recipient (simple storage on ice). Ex vivo organ treatment has since evolved towards perfusion of the donor organ to preserve its quality or to improve organ function and acceptability for transplantation. Today, continuous perfusion of donor organs with fluids during machine perfusion allows improved storage at low temperatures with assessment of critical organ function parameters. In addition, it also enables improvements of organ function during normothermic (i.e. body temperature) perfusion conditions with for example blood products or perfusion solutions that contain important nutrients, cells and even therapeutics, which are expected to improve the organ’s function and its longevity in the recipients after transplantation. Ex vivo machine perfusion increases the number of available transplanted organs via improvement of their function and subsequent acceptance for transplantation and ultimately improves the chance for a positive outcome of organ transplantation.
Synklino
Synklino is a Danish biotech company developing drugs to cure chronic viral infections with immediate focus on groundbreaking therapies against cytomegalovirus (CMV), a devastating viral infection in immunocompromised patients.
For additional information, please contact:
Synklino
Thomas Kledal, CEO
+45 2012 1656
tnk@synklino.com