Juvaris BioTherapeutics Announces Cooperative Research And Development Agreement With The Centers For Disease Control And Prevention

Juvaris BioTherapeutics,
Inc. announced 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).


Juvaris BioTherapeutics, Inc.

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