Flugen Inc., a Madison, Wis.-based company working on a universal flu vaccine, completed a $12.6 million series A financing to advance its plans to file an FDA investigational new drug application in the first half of next year, followed by a phase Ia study to look at safety and immune response in healthy adults. If successful, studies in other age groups and human influenza challenge studies would follow.

Venture Investors LLC led the round, which includes a new $9.4 million investment and contributions from a $3.2 million mid-2014 bridge round led by Knox LLC. Wisconsin Alumni Research Foundation, the State of Wisconsin Investment Board and existing investors also participated. To date, the company has raised about $19 million, primarily from local investors, angel investors and Knox, a family office created by University of Wisconsin, Madison, alumnus Frederick Mancheski.

Flugen's quadrivalent vaccine candidate, Redee Flu, is a single replication live attenuated H1N1pdm M2SR vaccine virus that is similar to wild-type virus but with deletions in the M2 envelope protein. Similar to the live attenuated influenza vaccine, it is administered intranasally, but while it infects cells, replicates and creates influenza RNA and proteins, it doesn't create progeny virions. The goal is to induce robust innate, antibody and cellular immune responses that can protect against "drifted" or even mismatched influenza strains, a feat it has already achieved in preclinical animal models.

Those studies have shown that not only does Redee Flu appear to protect against varied strains such as H3N2 or H1N1 subtypes, but also against completely different virus strains, such as H5N1, or avian flu.

"What we're trying to do is take a flu virus and mimic natural infection in the body without giving you the disease," Paul Radspinner, Flugen's president and CEO, told BioWorld Today. Though the company once explored a poker chip-sized patch to deliver an existing trivalent influenza vaccine, its resources are being devoted almost entirely to Redee Flu now. (See BioWorld Today, Dec. 18, 2009.)

In addition to the new investment, the company is also adding significant new expertise to its board, through the appointments of Dan Stinchcomb and C. Boyd Clarke as independent directors.

Stinchcomb, who is taking on the role of executive chairman, told BioWorld Today that "Flugen's vaccine, by infecting cells and producing all the influenza RNA and protein generates very good immune responses to more conserved parts of the virus, allowing it to offer protection against the wider panoply of strains." Such targeting, an approach that has defined current efforts to improve flu vaccines, was recently documented in two new scientific papers that explore elicitation of an immune response to a highly conserved region of the type one influenza A virus. (See BioWorld Today, Aug. 24, 2015.)

Stinchcomb was co-founder and CEO of Inviragen Inc., a privately held vaccine company, which developed vaccines for dengue fever, hand, foot and mouth disease and chikungunya. It was ultimately purchased by Osaka, Japan-based Takeda Pharmaceutical Co Ltd. in 2013 for $250 million. (See BioWorld Today, May 15, 2013.)

Clarke, who who will serve Flugen as an independent director, is former chairman and CEO of Aviron Inc., the original developer of Flumist (influenza vaccine live, intranasal). He ultimately sold the company to Gaithersburg, Md.-based Medimmune Inc. (now part of Astrazeneca plc) in 2001 for $1.5 billion. He has also served as executive chair for Ligocyte Pharmaceuticals Inc., which Takeda purchased for its virus-like particle platform technology in 2012. (See BioWorld Today, Dec. 4, 2001, and Oct. 8, 2012.)

Efforts to develop a universal flu vaccines have attracted significant scientific and commercial energy over the years, most recently from companies such as Biondvax Pharmaceuticals Ltd., which recently completed a phase II study of M-001, a synthetic peptide-based protein targeting both seasonal and pandemic strains of the influenza virus. Various academic research institutes are also in various developmental stages attempting to develop a universal influenza vaccine. And, of course, there are the major vaccine players such as Sanofi SA, Glaxosmithkline plc and CSL Behring. Word of continued progress on an effort to creat a universal protector came Monday, as Janssen Pharmaceuticals Inc. said that, together with researchers at the Scripps Research Institute, it had found a way to induce antibodies to fight a wide range of influenza subtypes.

Seasonal flu typically causes more than 200,000 hospitalizations and 36,000 deaths every year in the U.S., according to the Centers for Disease Control and Prevention, a cost that makes it clear that any and all the players making progress are likely to draw ongoing investment.