Juvaris BioTherapeutics Announces Award of U01 Cooperative Research Partnership from NIAID
Collaboration with Stanford and UC Davis to Focus on Adjuvant Development for the Next Generation of Influenza Vaccines
Dr. Chris Miller of the school's Department of Pathology, Microbiology and Immunology is the principal investigator on a subcontract in the award announced below by Juvaris BioTherapeutics July 31.
Miller's portion of the project aims to determine if reduced doses of influenza vaccine, when combined with the Juvaris adjuvant*, shows an enhanced or equivalent immune response when compared with full-strength vaccine. The rhesus monkey model of influenza virus infection is uniquely suited to this work due to the incredible similarity of the human and rhesus monkey immune systems and the natural susceptibility of the monkeys to Influenza A virus infection.
The award will also allow testing of novel vaccine strategies. Influenza viruses are highly changeable, and current vaccines may not be effective against new strains of virus. Miller's approach is designed to elicit immune responses to viral components that are similar across all influenza variants. Success in this area may help vaccine developers produce a vaccine that is effective even with newly emerging influenza strains. "It is hoped that this award will lead to vaccines that can blunt the impact of seasonal and pandemic Influenza A virus infections on humans," Miller states.
Pleasanton, CA - July 31, 2007
Juvaris BioTherapeutics, Inc. announced today that it has been awarded an estimated $9 million, 5-year grant by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop adjuvants for influenza vaccines. This research will be conducted in collaboration with Dr. David Lewis of Stanford University and Dr. Chris Miller of the National Primate Research Center at the University of California, Davis. The results obtained from research carried out under this cooperative partnership will also be applicable to other viral, bacterial and cancer vaccines using the JuvaVax (TM) adjuvant technology currently in development at Juvaris.
The award will examine the mechanism of action of JuvaVax adjuvanted vaccines and apply that knowledge to determine its efficacy when the influenza vaccination and challenge virus are matched as well as when they are mismatched. The collaboration will further examine the adjuvanting of vaccines currently administered in the U.S. as well as whole virus vaccines, which are used in Europe but not currently in the U.S.
“We are pleased to enter into this cooperative research partnership for influenza product development with NIAID,” said Martin D. Cleary, Co-founder, President and CEO of Juvaris. “We believe that the JuvaVax adjuvant can decrease the amount of vaccine necessary to induce protective immunity up to fifty-fold, which would be beneficial in cases of limited vaccine supply due to production issues or during an influenza pandemic. Furthermore, experiments have shown more cross-protection when the JuvaVax adjuvant is used with influenza vaccines, which would be useful in situations where the vaccination strain does not match the circulating strain. This award in a highly competitive environment reflects the potential of our technology platform, as well as the quality of our collaborators.”
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 (TM) 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 two clinical studies in 2008. The first will be a prophylactic vaccine for Influenza A and the second a therapy for chronic Hepatitis B.
Dr. Jeff Fairman, PI of the cooperative research partnership, will be presenting the Juvaris influenza program at the upcoming BARDA industry day, 11:00 AM August 3 at the Fairmont in Washington, D.C.
The Company encourage investment and partnering inquiries and can be reached at their Web site, www.juvaris.com.
*An adjuvant is a substance that helps and enhances the pharmacological effect of a drug or increases the ability of an antigen to stimulate the immune system--MedicineNet.com
Martin D. Cleary
Juvaris BioTherapeutics, Inc.