FluGen Initiates NIH-Funded Trial of M2SR Flu Vaccine; First Study in Adults Up to Age 85

MADISON, Wis., May 25, 2021 /PRNewswire/ -- FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the initiation of the first study in older adults of M2SR, the company's investigational supra-seasonal, live, single-replication, intranasal influenza (flu) vaccine. Funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), this study will assess the safety, tolerability, and immunological response to M2SR in adults up to age 85, a population most vulnerable to serious complications and mortality from the flu. The study will evaluate subjects' ability to raise antibodies against matched and drifted strains of the influenza virus. The extent to which all major components of the adaptive immune system are activated will also be measured. In a prior Phase 2 drifted H3N2 challenge trial, M2SR demonstrated efficacy against infection and illness across seven years of flu virus drift. Previous studies have also demonstrated that, unlike currently licensed influenza vaccines administered by intramuscular injection, intranasal M2SR stimulates mucosal and cellular immunity as well as serum humoral immunity. 

"Flu causes more serious illness, which results in a greater number of deaths in older adults, as compared to other populations, because their immune systems are typically less robust. Exposure to circulating virus that has drifted from the vaccine virus further compounds the burden of flu and makes protecting people in this age group by vaccination even more critical," said Dr. Carlos Fierro, Chief Medical Officer at Johnson County Clinical Trials, and Principal Investigator of the FluGen H3N2 v0005 clinical trial. "This study is important for advancing scientific understanding of all components of the adaptive immune system and how it responds to vaccine, as well as the duration of response in this vulnerable population."

The randomized, double-blind, placebo-controlled Phase 1b study, entitled FluGen H3N2 v005 (ClinicalTrials.gov NCT04785794) is designed to evaluate a monovalent Singapore 2016 H3N2 M2SR influenza A vaccine in a healthy adult population aged 50 to 85 years. The study will enroll 120 subjects in three successive age cohorts: 50-64 years old (n=15); 65-85 years old lead-in (n=15); 65-85 years old expansion (n=90). Subjects will be randomized 2:1 to receive a single dose of M2SR or placebo, delivered intranasally, and all subjects will receive a single dose of inactivated quadrivalent influenza vaccine (QIV) at least 28 days later. The primary endpoint is to measure the safety and tolerability of M2SR through 6 months post-vaccination. Secondary endpoints include the safety profile of QIV administered after receipt of M2SR. The study will also assess the immunogenicity, by serum and mucosal antibody responses, of one dose of Sing 2016 M2SR to matched and drifted strains of influenza virus. Additional immune parameters, including T-cell responses, may also be evaluated. Topline data are expected in the first half of 2022.

"There is a demonstrated unmet medical need to better protect older adults from the potentially deadly impact of influenza, and the current standard-of-care often provides less than optimal protection in this population," said Paul Radspinner, President and Chief Executive Officer of FluGen. "We have already demonstrated the ability of M2SR, our supra-seasonal, live, single replication, intra-nasal flu vaccine, to protect healthy adults when challenged with a 7-year drifted influenza strain. We have also previously demonstrated that M2SR mobilizes the full adaptive immune system. Now, in this highly vulnerable population, we aim to further show immunogenicity against matched and mismatched virus strains, as well as a broad immune response, including mucosal immunity, which is not typically seen with mRNA or inactivated vaccines."

This research is supported by NIAID under award number U01AI141310. The content of this announcement is the responsibility solely of FluGen, Inc. and does not necessarily represent the official views of NIH.

About FluGen:

FluGen, Inc. is a clinical-stage vaccine company transforming vaccine efficacy in respiratory diseases. The company's lead candidate is M2SR, a supra-seasonal, live, single-replication, intranasal flu vaccine. Unlike standard of care flu vaccines, M2SR stimulates mucosal, humoral, and cellular immunity. In an unprecedented challenge trial, M2SR demonstrated protection against infection and illness across seven years of virus drift; and M2SR induces a durable antibody response with potential to cover an entire flu season and beyond. M2SR also has shown activity as a vaccine vector for other respiratory vaccines and infectious diseases, including a COVID-19/flu combination. For more information about FluGen, Inc., please visit http://www.FluGen.com/.

SOURCE FluGen Inc

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