FluGen Announces Completion of First Cohort in Age De-escalation Clinical Trial of M2SR Flu Vaccine Candidate in Pediatric Subjects Ages 6 Months to 17 Years

– 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.

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/.

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.