FluGen Raises $2M More, Provides Update on Phase 1 Trial

Xconomy Wisconsin — 

FluGen has raised another $2 million from investors to support current and planned clinical trials of an experimental universal influenza vaccine that the Madison, WI-based startup is developing.

Paul Radspinner, who co-founded FluGen in 2007 and serves as the company’s president and CEO, says the latest funding is an addition to the $9.4 million funding round FluGen announced in 2015.

Twenty-nine investors participated in the equity funding round, according to a document filed with federal securities regulators. All the groups and individuals that contributed to the most recent round had invested in FluGen in the past, Radspinner says. The startup’s previous backers include Madison-based Venture Investors, the Wisconsin Alumni Research Foundation, the State of Wisconsin Investment Board, and Knox, a private fund on the East Coast.

FluGen has now raised a total of about $22 million from investors, Radspinner says.

Last July, the company announced it had initiated a Phase 1 clinical trial of its RedeeFlu vaccine. FluGen said at the time that the study was aimed at evaluating the safety of the vaccine, as well as the antibody and T-cell responses in participating patients.

Ninety-six subjects were dosed with the RedeeFlu vaccine as part of the trial, and Radspinner says that his company anticipates it will have data on all of them sometime this summer.

“We’re optimistic about the early signs we’re seeing right now, but we don’t have the full immunological picture yet,” he says.

Once it has data from the Phase 1 study in hand, FluGen could go in a couple of different directions, Radspinner says. One option is to conduct a Phase 1b study in older adults. Alternatively, FluGen could initiate a “challenge” study to potentially show that RedeeFlu can effectively fight a strain of the disease that doesn’t precisely match the strain that RedeeFlu is designed to combat.

“We would try to take on that idea of a ‘drifted’ strain—one that doesn’t match exactly—and try to show that our vaccine would work in that kind of a setting,” Radspinner says.

Part of the goal with a challenge study would be to test a vaccine’s ability to protect against the scenario that occurred in 2014 and 2015, when U.S. and global health agencies’ predictions of predominant strains for the impending flu season were off. That means flu vaccines distributed those years weren’t as effective as they could have been.

Expert forecasts turned out to be more accurate in 2016, Radspinner says. However, overall vaccine efficacy for influenza “remains relatively low,” he says.

“[It] still hovers in the 50 to 60 percent range, and tends to be worse in older adults and in children,” Radspinner says. “That’s where the majority of … severe illness and deaths come, is in the very young and very old.”

FluGen is also hoping to partner with an outside organization in the coming months to perform a study of RedeeFlu in pediatric patients, Radspinner says.