FluGen Snags $9.4M for Phase I Trial of Universal Flu Vaccine

Xconomy Wisconsin — 

[Corrected 8/25/15, 2:14 pm. See below.Madison, WI-based biotech startup FluGen has raised $9.4 million, which the company will use to start clinical trials on humans for its flagship vaccine candidate, designed to protect against multiple types of influenza, president and CEO Paul Radspinner said Monday.

The new financing follows a $3.4 million bridge round that FluGen closed in May 2014.

The four funds that participated in the most recent round were Madison-based Venture Investors, the Wisconsin Alumni Research Foundation (WARF), the State of Wisconsin Investment Board, and Knox, a private fund on the East Coast, Radspinner said.

The latest investment also brings four new faces to FluGen’s board of directors: Paul Weiss of Venture Investors; WARF’s Michael Falk; Dan Stinchcomb, whose company Inviragen was sold in 2013 to Takeda for $250 million; and C. Boyd Clarke, who was CEO of vaccine developer Aviron when MedImmune bought it for $1.5 billion in 2001. Stinchcomb will serve as FluGen’s executive chairman, said Radspinner. [An earlier version of this paragraph incorrectly stated Inviragen’s sale price. We regret the error.]

Radspinner said FluGen, which he co-founded in 2007 with Yoshihiro Kawaoka and Gabriele Neumann, has to date raised about $20 million in total.

FluGen’s focus for the next year will be, “getting into the clinic as fast and as safe as possible,” said Radspinner.

“That first human data is going to give us a signal as to how good we are,” he said.

Unlike many competing flu vaccines on the market and in development, said Radspinner, FluGen’s “RedeeFlu” technology primes the four major components of the immune system—cell-mediated, humoral, innate, and mucosal—to respond to a flu virus. The vaccine is made up of a live flu virus from which a key gene, known as M2, has been deleted; the vaccine virus is able to live in the body just long enough to provoke a strong immune response, but thanks to the deleted gene it’s not able to cause disease or spread to other people.

Companies such as Fort Collins, CO-based Vivaldi Biosciences are also developing vaccines that trigger a response from the four major immune system components, said Radspinner. But FluGen is the only one that does so by removing the M2 gene, he said. Radspinner said he expects FluGen’s first human trials will reveal that RedeeFlu is more effective than the flu vaccine developed by Vivaldi, which he said experienced “disappointing results in their first human studies.”

Radspinner said he and his team expect RedeeFlu to be versatile in protecting people from different flu strains, based on early studies of the vaccine in ferrets.

“With a single dose of vaccine, we were able to protect ferrets from H5N1 bird flu, which kills up to 60 percent of the people that get it,” he said. “We gave them an H1N1 seasonal vaccine of ours, and it protected them from a completely different virus. If we can get that kind of cross-protection, this is going to be a robust vaccine that’s going to be able to protect and save a lot of lives.”

You don’t need to go very far back in time to see the vast potential of a vaccine that’s designed to be adaptable. In 2014, the CDC and WHO predicted that H3N2 would be one of the predominant strains for the flu season, and that year’s vaccines were designed to protect against it, but H3N2 “ended up not being the dominant strain in the environment,” said Radspinner.

“The new virus had a couple amino acid changes and thus the vaccine was helpless to protect against it,” he said. “If our animal studies prove predictive, RedeeFlu would have protected against [the new virus] even though it was made as [H3N2].”

FluGen must pay to have a stock of its vaccine manufactured for human tests before it can begin a clinical trial, Radspinner said. After that, the next step is to seek permission from the FDA to begin a Phase 1a trial of the vaccine, which Radspinner said will likely happen in the spring of 2016. The trial would include around 100 people, he said.

Radspinner said he doesn’t see a hiring spree in FluGen’s immediate future, in part because the 10-person firm outsources tasks like materials manufacturing.

While Radspinner said the company now has enough capital to last through the end of 2016—“We’re set for now until roughly the end of the Phase I clinical trials,” he said—FluGen’s website still lists directions for visitors wanting to “explore investment opportunities.”