Biopharma companies big and small are seeking to advance flu vaccine research as recent seasons have underscored issues with traditional vaccines. Now, FluGen reports its intranasal vaccine succeeded in a phase 2 challenge study against a “highly mismatched” strain of the virus.
In the study, which enrolled 99 healthy adults, investigators tested FluGen’s M2SR—targeting a 2007 flu strain—against a strain that circulated several years later. The participants received either the vaccine or an intranasal placebo and were exposed to a live H3N2 influenza virus from 2014-2015.
Despite the mismatch, more than half of study participants who received FluGen’s vaccine showed a serum antibody response to the vaccine, the company reports; those participants saw a 34% viral load reduction compared with the placebo group. Those who developed antibodies to both the vaccine and the challenge virus showed a 62% reduction in viral load, according to the biotech.
Aside from viral load, the vaccine also helped with symptoms, FluGen reports.
The National Institutes for Allergy and Infectious Diseases helped develop the vaccine, and the U.S. Department of Defense sponsored the trial.
FluGen’s clinical advisory board chair Robert Belshe, who’s also a Saint Louis University infectious diseases and immunology professor, in a statement said the results are 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.”
Next, FluGen plans to complete the analysis and present the subject the results to peer review. The company’s CEO Paul Radspinner said in a statement the company is “excited to advance the development of M2SR based on these significant results.”
Privately held FluGen, which was founded in 2007, reported early human results for the vaccine back in October. Other companies working on so-called “universal” flu vaccines include Johnson & Johnson, Sanofi, Vaccitech and BiondVax.