FluGen Begins Enrollment of Clinical Trial of Novel Investigational Influenza Vaccine Against Multi-Season Mismatched …

MADISON, Wis.–()–FluGen, Inc. announced today that the first subject has been dosed in a
clinical study in Belgium which will challenge subjects with an
influenza virus genetically mismatched by six years from the influenza
strain utilized in the vaccine.

“If successful, the results from this challenge study of FluGen’s M2SR
vaccine would represent a significant step forward in bringing a novel
influenza vaccine to patients; and which responds to the need for
broader protection and increased effectiveness, as compared to existing
influenza vaccine options,” said Paul Radspinner, chief executive
officer of FluGen.

“The potential mismatch between current influenza vaccines and the
circulating strains is one of the biggest annual challenges for
prevention of influenza. Even in years when we do get a good match with
all strains, traditional vaccine effectiveness is often less than 50
percent. In years where we do not closely match the vaccine to
circulating virus strains, like this past flu season, it can be much
lower, and low efficacy puts people at risk for potentially severe
illness,” said Robert Belshe, M.D., chair of the FluGen clinical
advisory board and the Diana and J. Joseph Adorjan Endowed Professor of
Infectious Diseases and Immunology, Emeritus, at Saint Louis University.

FluGen’s M2SR vaccine seeks to address this challenge. The vaccine
utilizes a proprietary M2 deleted, single replication (M2SR) influenza
virus. The M2 gene is essential for the influenza virus to spread in the
patient and the deletion of the M2 gene restricts the virus to a single
replication cycle in the host. The body recognizes M2SR as an influenza
infection and activates its robust immune response, but, because the
virus can only replicate once, it cannot spread to other cells and cause
symptoms of a real-world infection.

Patients naturally infected with wild type influenza often are protected
from future influenza illness for many years. By tricking the body into
believing it has been infected with influenza, the M2SR vaccine is
designed to activate this broad and durable wild type immune response,
without causing influenza disease.

“If FluGen’s M2SR vaccine can provide protection against a significantly
drifted strain of influenza, it will give us the potential of increasing
influenza vaccine efficacy by broadening immune responses. M2SR has the
potential to solve one of the greatest problems for prevention of
influenza, selecting the exactly right strain to put in the vaccine. We
expect M2SR to mimic the benefits of high protection seen after natural
infection, but without causing influenza illness that is associated with
community acquired wild type influenza infection,” Belshe added.

Study Design

In the study, being conducted by SGS in Belgium, subjects will be
randomized 1:1 to receive either intranasal placebo, or intranasal M2SR
vaccine, manufactured with the A/Brisbane/10/2007, H3N2 strain of
influenza, which was utilized in marketed influenza vaccines during the
2008-2010 influenza seasons.

Subjects will then be challenged intranasally with the
A/Belgium/4217/2015, H3N2 influenza virus, which is a genetically
drifted virus that caused outbreaks of influenza in 2015. Subjects will
be followed on an ongoing basis for four months. Target enrollment for
the study is 96 total subjects.

The primary endpoint of the study is influenza infectivity in the
placebo group compared to the group vaccinated with M2SR. Safety and
immunogenicity data also will be evaluated for all subjects.

The study is supported by a $14.4 million grant from the Department of
Defense. The U.S. Army Medical Research Acquisition Activity is the
awarding and administering acquisition office and this work was
supported by the Office of the Assistant Secretary of Defense for Health
Affairs through the Peer Reviewed Medical Research Program under Award
No. W81XWH-17-1-0430.

A prior Phase 1a study of FluGen’s M2SR vaccine in 96 subjects showed
the vaccine to be generally safe and well tolerated, and to generate a
robust immune response.

About FluGen, Inc.

FluGen, Inc. is a clinical stage vaccine company focused on improving
the breadth and effectiveness of influenza vaccines. The company’s
technology comes from the laboratory of Dr. Yoshihiro Kawaoka at the
University of Wisconsin, Madison. FluGen’s lead product candidate, an
M2SR vaccine, is a universal flu vaccine which is based on the knowledge
that a natural or wild-type flu infection prevents people from being
infected in subsequent years. The M2SR vaccine has demonstrated a robust
immunology profile that works through multiple immune pathways systems
and appears to trick the body into believing it has been infected,
triggering a robust immune response while not displaying flu symptoms.

For more information about FluGen, Inc., please visit http://www.FluGen.com/

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