FluGen’s vaccine proves effective in human challenge trial

Madison firm one step closer to universal flu shot

Last updated on July 2nd, 2019 at 09:04 pm

Madison-based biotechnology firm FluGen Inc. announced today its flu vaccine proved effective against a highly mismatched influenza virus in a human challenge trial.

The company has been working to develop a universal flu vaccine that can protect against strains of the virus that have drifted significantly from the strains included in traditional vaccines. The hope is this vaccine could be used for multiple years, which would address the problem of the flu strain changing before the traditional vaccine comes out for a particular flu season.

Preliminary data from FluGen’s Phase 2 clinical trial on its investigational intranasal M2SR vaccine shows it was effective against a six-year mismatch of strains. The trial was funded by the U.S. Department of Defense.

FluGen’s double-blind, placebo-controlled trial of 99 healthy adults compared the 2007 virus M2SR vaccine with the H3N2 influenza virus from 2014-’15. M2SR was effective in reducing both viral load and symptoms among patients who were challenged with a high dose of the H3N2 virus.

“Considering the generally low vaccine effectiveness of marketed injectable vaccines, as well as the serious consequences when the influenza virus drifts just slightly from the currently licensed annual flu vaccine, we wanted to better understand how broadly FluGen’s M2SR vaccine could protect if the flu virus had dramatically mutated not one year, but over six influenza seasons,” said Paul Radspinner, chief executive officer of FluGen. “With the financial support we have in place from our investors and government partners, we are excited to advance the development of M2SR based on these significant results.”

FluGen, which was established in 2007 and has about 13 employees, has raised more than $28 million in debt and equity funding from investors. It most recently completed a $5.6 million debt funding round in November.

“The problem of seasonal drift and mismatches between the annual influenza vaccine and circulating strains is a significant public health challenge and contributes to the low effectiveness and increased illness and mortality we see too often,” said Dr. Robert Belshe, chair of the FluGen clinical advisory board and the Diana and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology, emeritus, at Saint Louis University. “The remarkable results from this trial of FluGen’s M2SR vaccine mark an important step forward in the development of a more universal flu vaccine and take some of the guesswork out of picking strains to put in the vaccine. No one, to my knowledge, has ever tried a study like this before.”

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