FluGen’s Intranasal M2SR Flu Vaccine, Co-Administered with High Dose Vaccine, in Older Adults Shows Superiority Over Flu Shot Alone
2024年7月12日 - 8:00PM
FluGen, Inc., a clinical-stage vaccine company transforming vaccine
efficacy in infectious respiratory diseases, today announced the
results of its study comparing the coadministration of intranasal
M2SR and the high dose flu shot in an unprecedented study of older
adults ages 65-85 years. The findings are reported today in the
journal Lancet Infectious Diseases
(https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00351-7/fulltext).
The study evaluated the safety, tolerability, and immunological
response to FluGen’s investigational supra-seasonal, live,
single-replication, intranasal influenza (flu) vaccine when
administered with Sanofi’s Fluzone High Dose inactivated influenza
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 evaluated M2SR and Fluzone High Dose alone, and
dosed concomitantly, in healthy adults 65-85 years of age, a
population considered highly vulnerable to mortality from flu.
“Influenza continues to be a major cause of
seasonal respiratory epidemics with significant morbidity and
mortality, especially in older adults. Current vaccines fall short
in three main areas – they don’t last long enough, they don’t
protect against viruses that mutate and they don’t block the
initial infection in the upper respiratory tract,” said Robert
Belshe, MD, founder of Saint Louis University’s Center for Vaccine
Development and recipient of the 2023 American College of
Physicians James D. Bruce Memorial Award for Distinguished
Contributions in Preventive Medicine “The results from this study
represent a potential solution that might save millions of older
adults from getting sick or worse.”
Intranasal vaccines are known to provide a wall
of defense at the site of infection to help prevent influenza
viruses from entering the nasal mucosa. Intranasal M2SR has shown
the ability to elicit mucosal antibodies and also protect against
drifted strains while being durable. Standard flu shots on the
other hand, generate antibodies in the blood to help fight off the
virus after it has already entered the body. Combining the benefits
of both nasally delivered vaccines and the standard shot provide
the best of both worlds.
The study demonstrated M2SR’s ability to
statistically significantly raise mucosal antibodies in the nasal
passages, serum antibodies against matched and drifted strains of
the influenza virus, and cellular immune responses in subjects when
compared to Fluzone High Dose and placebo. 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.
“The idea of delivering two vaccines in one
sitting has become widely accepted,” said Paul Radspinner,
President and Chief Executive Officer of FluGen. “Imagine being at
your local pharmacy for your annual flu shot and also receiving a
quick nasal spray that would greatly enhance your chances not only
of becoming seriously ill but of being infected at all. This
combination solution could have a tremendous impact on the health
of older adults."
Radspinner went on to discuss the possible
impact on influenza pandemic protection. “If H5N1 or any other
mutating influenza strain were to begin infecting millions of
people as SARS-CoV-2 did, imagine the benefits of combining an
intranasal vaccine, which could stop most infections from
occurring, with a strong antibody-based vaccine shot. The impact on
human health could be unequalled in our history.”
The randomized, double-blind, placebo-controlled
Phase 1b study, entitled FluGen H3N2 v006 (ClinicalTrials.gov
NCT05163847) was designed to evaluate a monovalent Cambodia 2020
H3N2 M2SR influenza A vaccine in a healthy, older adult population.
The study enrolled over 300 subjects in four cohorts receiving
either M2SR alone, high dose IIV alone, both vaccines concomitantly
or placebo. The primary endpoint was 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 included evaluation of serum and mucosal
antibody responses to matched and drifted strains of influenza
virus following monovalent M2SR influenza vaccine delivered
intranasally alone or concomitantly with high dose IIV delivered
intramuscularly. Exploratory endpoints included evaluation of
additional immune parameters such as T-cell responses.
This work was supported by The Assistant
Secretary of Defense for Health Affairs endorsed by the Department
of Defense, in the amount of ($11,439,843.00), through the Peer
Reviewed Medical Research Program under Award Number
(W81XWH-21-1-0563). Opinions, interpretations, conclusions, and
recommendations are those of the author(s) and are not necessarily
endorsed by The Assistant Secretary of Defense for Health Affairs
endorsed by the Department of Defense.
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 human 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 positive initial results as a vaccine vector for other
respiratory vaccines and infectious diseases, including a
COVID-19/flu combination and for RSV. For more information about
FluGen, Inc., please visit http://www.FluGen.com/
Contact:
Media – Paul V. Radspinner, 608-658-6095, pradspinner@flugen.com