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."
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.
SOURCE Juvaris BioTherapeutics, Inc.