FluGen Announces First Subject Dosed in Phase 1b Clinical Trial of its Intranasal M2SR Flu Vaccine, Co-Administered with High Dose Vaccine, in Older Adults

– Study will measure immune responses generated by M2SR and high dose vaccine separately and in combination in the highly vulnerable 65-85 years old population –

– Funded by the US Department of Defense, this study is expected to yield topline data in 2H 2022 –

MADISON, Wis., June 22, 2022 /PRNewswire/ -- FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the dosing of its first subject in an unprecedented study of older adults ages 65-85 years. The study will evaluate the safety, tolerability, and immunological response to FluGen's investigational supra-seasonal, live, single-replication, intranasal M2SR influenza (flu) vaccine, and high dose inactivated vaccine (IIV). There is a demonstrated unmet need for improved flu vaccine options, as current injectable vaccines primarily generate hemagglutinin (HA) antibodies and have shown only modest efficacy in most flu seasons. Funded by the U.S. Department of Defense (DOD), this study will evaluate M2SR and high dose IIV alone, and dosed concomitantly, in healthy adults 65-85 years of age, a population considered highly vulnerable to mortality from flu.

"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," said Yoshihiro Kawaoka, Professor of Virology, University of Wisconsin and FluGen co-founder. "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."

The synergistic effects of combining intranasally delivered M2SR with intramuscularly delivered high dose IIV is a novel approach that could significantly boost the effectiveness of flu vaccines and protect from the drifting of flu strains from year to year. The study will evaluate subjects' ability to raise mucosal antibodies in the nasal passages, serum antibodies against matched and drifted strains of the influenza virus, and cellular immune responses. 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 while currently licensed influenza vaccines administered by intramuscular injection generate tremendous antibody responses, only intranasal M2SR stimulates mucosal and cellular immunity as well as serum antibodies.

"Combination therapy is used to combat many diseases including cancer, tuberculosis, and HIV, yet this approach has not been seriously pursued with vaccines," said Paul Radspinner, President and Chief Executive Officer of FluGen. "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."

The randomized, double-blind, placebo-controlled Phase 1b study, entitled FluGen H3N2 v006 (ClinicalTrials.gov NCT05163847) is designed to evaluate a monovalent Cambodia 2020 H3N2 M2SR influenza A vaccine in a healthy, older adult population. The study aims to enroll 300 subjects in four cohorts receiving either M2SR alone, high dose IIV alone, both vaccines concomitantly or placebo. The primary endpoint is to assess the safety and tolerability of a single dose of monovalent M2SR influenza vaccine delivered intranasally alone or concomitantly with high dose IIV delivered intramuscularly to healthy subjects 65 to 85 years of age. Secondary endpoints include evaluation of serum and mucosal antibody responses to matched and drifted strains of influenza virus monovalent M2SR influenza vaccine delivered intranasally alone or concomitantly with high dose IIV delivered intramuscularly. Exploratory endpoints include evaluation of additional immune parameters such as T-cell responses. Topline data are expected in the second half of 2022.

This research is supported by the DOD under award number W81XWH2110563. The content of this announcement is the responsibility solely of FluGen, Inc. and does not necessarily represent the official views of DOD.

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