FluGen Initiates a Phase 1 Clinical Trial of the RedeeFlu™ Universal Influenza Vaccine in Healthy Subjects

MADISON, Wis.–(BUSINESS WIRE)–FluGen Inc., a clinical-stage biopharmaceutical company focused on the
discovery and development of more effective influenza vaccines, today
announced the initiation of the first Phase 1 clinical trial of its
RedeeFlu™ universal influenza vaccine. The trial is a randomized,
blinded, dose-ranging Phase 1 study of the H3N2 RedeeFlu™ influenza
vaccine in 96 healthy adult subjects between 18 and 49 years of age. In
addition to the trial’s primary goal of evaluating the safety of the
vaccine in this population, the study also will evaluate both antibody
and T-cell responses induced by the vaccine.

“The initiation of this first in man study is an important milestone
achieved through the research and development efforts of the FluGen team
and our collaborators. We believe that RedeeFlu™ could be the first
influenza vaccine to show robust protection from drifted or mismatched
flu strains,” said Paul V. Radspinner, President & CEO.

During the 2014-15 flu season in the US, the chosen vaccine strain was
different than the “drifted” circulating virus. As a result, the
existing flu vaccines had dramatically reduced efficacy. During the
2015-16 flu season questions have been raised about the effectiveness of
live attenuated influenza vaccines. The RedeeFlu™ vaccines are novel,
M2-deleted single replication (M2SR) viruses that rapidly induce
antibody and cellular immune responses similar to wild type influenza,
but cannot produce infectious virus. In multiple preclinical models,
RedeeFlu™ (M2SR) vaccines have demonstrated superior protection against
both drifted and completely mismatched strains of influenza when
compared to other live or inactivated influenza vaccine technologies.
RedeeFlu™ vaccines also have protected against influenza in older
animals and in the face of pre-existing immune responses.

“Most of the morbidity and mortality associated with influenza is
experienced by young children and older adults,” said Dr. Dan
Stinchcomb, Executive Chairman. “This trial is the first step in a
clinical development plan designed to assess the safety of H3N2
RedeeFlu™ (M2SR) and to demonstrate the breadth of protection in
multiple age groups. If our preclinical results are reproduced in human
clinical studies, RedeeFlu™ (M2SR) could meet a significant global
health need.”

Additional information regarding the Phase I clinical trial can be found
under ClinicalTrials.gov identifier NCT02822105.

About Influenza

Influenza (flu) is a contagious respiratory disease caused by influenza
viruses. The influenza virus is transmitted easily from person to person
via droplets and small particles produced when infected people cough or
sneeze. Influenza tends to spread rapidly in seasonal epidemics.
Infection usually lasts for about a week, and is characterized by sudden
onset of high fever, aching muscles, headache and severe malaise,
non-productive cough, sore throat and rhinitis. Some people are at high
risk for serious flu complications, including the elderly, young
children, pregnant women, and people with certain health conditions such
as asthma, chronic lung disease, diabetes, heart disease, blood, kidney
or lung disorders, or weakened immune systems. Worldwide, it is
estimated that 3 to 5 million cases of severe influenza and 250,000 to
500,000 influenza-related deaths occur every year.

About FluGen, Inc.

FluGen, Inc. is a privately held biotechnology company founded in 2005
and based in Madison, WI. The company has been developing novel
influenza vaccine technology first invented at the University of
Wisconsin-Madison, in the laboratories of Dr. Yoshihiro Kawaoka and Dr.
Gabriele Neumann, and exclusively licensed to FluGen by WARF. The
RedeeFlu™ influenza vaccine contains mutations in the M2 gene of the
virus. The mutated virus can infect cells, express the entire spectrum
of influenza RNA and proteins, yet fails to produce any infectious virus
particles. Thus, the vaccine does not shed infectious virus and does not
cause any pathological signs of infection. In multiple animal models,
RedeeFlu™ is safe yet induces robust innate, antibody and cellular
immune responses that can protect against “drifted” or even mismatched
influenza strains. The Company is developing RedeeFlu™ to address two
unmet needs in the prevention of human influenza: better protection
against influenza in the elderly and better protection against drifted
influenza strains that can cause influenza epidemics. More information
is available at www.flugen.com.


FluGen Inc.
Paul V. Radspinner
President & CEO