H3N2 M2SR influenza vaccine (FluGen)

– Four leading pediatric infectious disease institutions will study M2SR vaccine response in pediatric subjects, a population in which infection rates are often highest – – Collaborative study led by National Institute of Allergy and Infectious Diseases' "Collaborative Influenza Vaccine Innovation Centers" program – MADISON, Wis., Sept. 7, 2022 /PRNewswire/ -- FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the completion of enrollment of the first cohort in an age de-escalation clinical trial of M2SR ( M2 Deficient Single Replication) live virus vaccine, the company's investigational supra-seasonal intranasal influenza (flu) vaccine, in volunteers ages 6 months to 17 years old. This study is the first of its kind to evaluate M2SR in children under 9 years old, a population with the greatest rates of flu infection each year and who are at higher risk of serious complications or death. The study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) program will assess safety, tolerability, and immunological response to M2SR. "Influenza can have serious complications in young children, a particularly vulnerable patient population, and there is a demonstrated need for improved vaccines that can mitigate the impact of the flu," said Dr. James Campbell, Professor of Pediatrics at the University of Maryland School of Medicine and Principal Investigator of the study. "The M2SR vaccine candidate has already shown a robust safety profile in adults, and we look forward to advancing scientific understanding of the potential benefits of M2SR in children." The randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled, Phase 1b study, (clinicaltrials.gov NCT04960397) is designed to evaluate a monovalent Singapore 2016 H3N2 M2SR influenza A vaccine in children. The primary endpoint is to measure the safety and tolerability of M2SR. The secondary endpoint is to assess the humoral immunogenicity (serum antibody and mucosal antibody responses) directed against the matched virus strain. The study will enroll 220 participants in three cohorts: 9-17 years old (n=45); 2-8 years old (n=115); and 6-23 months old (n=60); and will occur over two flu seasons. Participants will be randomized to receive either one or two doses of a monovalent M2SR vaccine (at increasing doses of 107, 108, or 109 TCID50) or placebo delivered intranasally. All participants will be offered the seasonal influenza vaccine at the end of the study period. "The rate of influenza infection is highest in pediatric patients, and the current standard-of-care does not meet the needs of this unprotected population," said Paul Radspinner, President and Chief Executive Officer of FluGen. "We are pleased that the NIH has selected our M2SR flu vaccine candidate to be studied as part of its CIVICs program, and look forward to sharing further updates, and the initial results of the study, which are expected in the first half of 2023." FluGen's novel supra-seasonal, intranasal M2SR flu vaccine has already been studied in more than 200 subjects aged 9 to 55 years and has shown a strong safety and immunogenicity profile. It is also being studied in a separate ongoing study in adults 55 to 85 years old. The study in pediatric subjects is supported by NIH CIVICs under contract numbers 75N93019C00055 to University of Maryland School of Medicine and 75N93019C00054 to Duke University. In addition to James Campbell, M.D. at the University of Maryland, Emmanuel Walter, M.D. at Duke University, Clarence Creech at Vanderbilt University and Patricia Winokur, M.D. at the University of Iowa will serve as investigators for the study. 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 . About M2SR: The M2 Deleted Single Replication Live Virus Vaccine (M2SR) offers a potentially differentiating clinical value proposition. FluGen's flu vaccine candidate works differently, stimulating mucosal, humoral, and cellular immunity, and offering unprecedented efficacy against infection and illness across seven years of virus drift, and documented immune response for at least six months. SOURCE FluGen, Inc.

– 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 . SOURCE FluGen Inc