Juvaris BioTherapeutics Announces Cooperative Research and Development Agreement...

Juvaris BioTherapeutics Announces Cooperative Research and Development
Agreement With The Centers for Disease Control and Prevention
Collaboration with CDC to Focus on Testing of Juvaris JVRS-100 as an Adjuvant
with existing H5N1 vaccine for dose-sparing and cross protection

PLEASANTON, Calif., Jan. 15 /PRNewswire/ -- Juvaris BioTherapeutics, Inc.
announced today that The Centers for Disease Control and Prevention and
Juvaris BioTherapeutics, Inc. have entered into a Cooperative Research and
Development Agreement (CRADA) for the evaluation of a JVRS-100 adjuvanted H5N1
pandemic influenza vaccine. The ability of JVRS-100 to aid in the induction
of a protective antibody response to the H5N1 vaccine at low doses of vaccine
will be confirmed. This collaborative study will determine if the use of the
Juvaris JVRS-100 adjuvant will extend the limited supply of H5N1 vaccines in
the event of a pandemic.
In preparation for the possibility of an influenza pandemic caused by an
H5N1 avian influenza virus that has obtained the ability to be easily
transmitted from person to person, several strains of H5N1 viruses have been
used to prepare killed-virus vaccines. Vaccine trials in people testing the
immunogenicity of these pre-pandemic vaccines have shown that high vaccine
doses are required to produce an antibody response that is believed to be
protective. In order to lower the dose of vaccine and extend the supply of
available vaccine, a number of immune boosters known as adjuvants are being
tested.
"Although the principal commercial value of JVRS-100 will be as a
mono-immunotherapy, we are pleased to enter into this CRADA with CDC for
testing of the JVRS-100 as an adjuvant for potential extension of the current
supply of H5N1 vaccine," said Martin D. Cleary, Co-founder, President and CEO
of Juvaris. "In preclinical studies using seasonal influenza vaccine our
adjuvant can decrease the amount of vaccine necessary to induce protective
antibody immunity up to fifty-fold, which would be beneficial in case of
limited vaccine supply during an influenza pandemic. Furthermore, preclinical
experiments with inactivated virus have shown greater cross-protection when
our adjuvant is used."
About Juvaris
Juvaris BioTherapeutics was created in 2003 to develop an
immunotherapeutic product platform for the treatment of infectious diseases
and cancers using lipid-DNA complexes. Cationic lipids are formulated with
non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a lipid-DNA
complex, which as a single product will have utility in multiple infectious
disease and cancer applications. The JuvImmune product has been shown to be at
least 50-times more potent at triggering innate immune activation and
interferon release than current immune stimulants.
When combined with disease-specific antigens, the technology creates
JuvaVax vaccines capable of activating substantial antibody- and cell-mediated
immune responses, particularly induction of cytotoxic T lymphocytes (CTL).
Immunological responses elicited by the lipid-DNA complexes have been
successfully demonstrated in both prophylactic and therapeutic settings in a
variety of mammals including rodents, rabbits, cats, dogs and non-human
primates. This platform provides the opportunity to develop many
disease-specific immunotherapy products, for which there are significant unmet
medical needs.
The Company recently completed a Series A financing with Kleiner Perkins
Caufield & Byers as the sole investor. It plans to start up to four clinical
studies in 2008. The first will be a prophylactic vaccine for Influenza A,
the second a therapy for chronic Hepatitis B, the third for chronic Hepatitis
C and a fourth for Acute Myelogenous Leukemia (AML).
The Company encourages partnering inquiries and can be reached at its
website @ http://www.juvaris.com.
Company Contact:
Martin D. Cleary
Juvaris BioTherapeutics, Inc.
925.399.6200
mdcleary@juvaris.com

SOURCE Juvaris BioTherapeutics, Inc.

Martin D. Cleary of Juvaris BioTherapeutics, Inc., +1-925-399-6200,
mdcleary@juvaris.com