FluGen has announced that preliminary data from a Phase 2 trial show that its intranasal M2SR manufactured with a strain of influenza that was used in vaccines during the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season. Demonstrating protection against the highly mismatched virus is a “major step toward demonstrating breadth of protection” that “is key to developing a universal flu vaccine,” the company said.
The Redee Flu vaccine is based on technology from the University of Wisconsin. A Phase 1 trial previously demonstrated that the vaccine produced a dose-related robust immune response, according to Flugen.
In the challenge study, over 50% of subjects who got the M2SR intranasal flu vaccine had a serum antibody response to the vaccine, and averaged a 34% reduction in viral load when challenged with the H3N2 virus compared to placebo. For subjects who developed antibodies to both the vaccine and the mismatched virus the reduction in viral load was 62% compared to placebo. Both groups also had reduced symptoms.
The US Department of Defense awarded FluGen a $14.4 million grant to fund studies of its vaccine against mismatched viruses through the DOD’s Congressionally Directed Medical Research Programs Peer Reviewed Medical Research Program.
FluGen CEO Paul Radspinner said, “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. 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.”
Read the FluGen press release.
