FluGen said that the first subject has been dosed in a Phase 1b study of its M2SR intranasal live single replication flu vaccine and an intramuscular high dose inactivated vaccine (IIV) in adults aged 65 to 85 years. The study, which is funded by the US Department of Defense, will evaluate each of the vaccines separately, as well as the intranasal and IIV vaccines dosed together, compared to placebo in approximately 300 subjects. The company said that it expects to have topline data later this year.
One of the goals of the study will be to evaluate mucosal and serum antibody responses to the Cambodia 2020 H3N2 M2SR influenza A vaccine and the IIV vaccine against drifted strains of the virus. In February 2019, the company reported that a Phase 2 trial of M2SR manufactured with a strain of influenza from the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season.
FluGen co-founder Yoshihiro Kawaoka said, “We have seen numerous approaches to solving the challenge of influenza vaccine efficacy over the past decade, but despite these efforts, none have achieved the efficacy needed to improve health outcomes. This study is important, as it is the first of its kind to combine intranasal vaccine delivery with intramuscular shots to determine the potential for boosting vaccine efficacy and reducing transmission and virus shedding.”
President and CEO Paul Radspinner added, “Combination therapy is used to combat many diseases including cancer, tuberculosis, and HIV, yet this approach has not been seriously pursued with vaccines. There is a demonstrated unmet medical need to better protect older adults from the potentially deadly impact of influenza, and this research into the potential of combining intranasal delivery of a live M2SR virus vaccine and the strong antibody response provided by high dose IIV, may not only help potentially improve outcomes associated with flu, but may also yield important insights to guide further research into combination vaccine approaches for other viruses including the SARS-CoV-2 virus that causes COVID-19.”
Read the FluGen press release.
