Latent or lytic infection? Doesn't matter, Danish biotech says for transplant-related cytomegalovirus drug
Most people in the world have cytomegalovirus, or CMV for short, but it has no effect. However, for some immunocompromised individuals and newborns, the usually harmless virus can cause serious disease involving fever, nausea and vomiting. In transplant patients who have to take immunosuppressive meds, an active CMV infection can also raise the chance of organ rejection.
Those transplant patients at risk for CMV infection are the group that Denmark-based biotech Synklino is hoping to treat with its drug candidate, dubbed SYN002. The biotech has raised €29.8 million ($31.9 million) to move that candidate towards clinical trials, it announced today.
Synklino’s candidate deals with human CMV, not pig CMV, which caused a recent xenotransplanted heart recipient’s death. (Pig CMV does not infect human cells.)
Unlike current treatment options for CMV infection, Synklino’s candidate not only attacks active infections, but also latent ones, Synklino CEO Thomas Kledal told Endpoints News. The drug targets a protein known as US28 which can be found on the surface of both the lytic and latent versions of the common herpesvirus.
Synklino’s site boldly claims that it has “curative potential,” though Kledal noted that “it’s impossible to claim there isn’t one residual viral particle left in a human host, so of course we cannot claim we have a 100% cure.
“But what we are working for is to have a situation where we don’t see the virus come up and constitute clinical problems for our patient, and this is really what we mean by a functional cure,” he added.
The Danish biotech is a small challenger to Takeda, which had its post-transplant-specific CMV drug with a somewhat chaotic history approved following a unanimous adcomm vote. However, a number of antivirals, including Zirgan (ganciclovir) are indicated to treat CMV infections more broadly.
While not trying to treat CMV, Moderna is developing a vaccine for the virus, which is also the leading infectious cause of birth defects in the US. The big biotech also recently launched an awareness campaign about it.
Kledal said he hopes Synklino’s candidate will be in clinical trials in the first half of next year. The biotech is planning to run trials in humans as well as in organs prior to transplantation, Kledal said.
While a transplant organ is being stored, “we can add SYN002 to the circulatory circuit coupled to the arteries, veins of that organ — flush the organ — and because we can target latency, we can actually target the reservoir cells that are infected in that organ prior to these being transplanted into the recipient,” Kledal said.
In addition, because the drug can go after the virus in its sleeping state, the drug can first be tested in healthy volunteers to measure its impact on the latent CMV reservoir, Kledal noted.
PKA pension fund led Synklino’s series A funding round, followed by the Danish Growth Fund and Eir Ventures.