Juvaris BioTherapeutics Announces Positive Data from Clinical Trial of JVRS-100 Adjuvanted Flu Vaccine
Burlingame, CA - January 8, 2009
Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines and immunotherapeutics for infectious diseases and cancer, today announced positive results from a Phase 1 clinical trial of its lead compound, JVRS-100, as an adjuvant for influenza vaccines.
Results from the randomized, double blind, controlled trial demonstrated positive effects of the JVRS-100 adjuvant co-administered with a commercial influenza vaccine compared to vaccine alone. Increased antibody responses measured by serum hemagglutination inhibition (HAI) and neutralizing antibody titers were observed in subjects receiving JVRS-100 and vaccine versus vaccine alone in study participants 28 days post-vaccination. HAI and neutralization titers are the accepted correlates of increased protection against illness after exposure to influenza. JVRS-100 administered at the most efficacious dose was well tolerated, with no additional side effects over those associated with influenza vaccine alone. The trial enrolled 128 healthy adult subjects 18 to 49 years of age.
"It is very encouraging to see proof-of-concept in the clinic with this novel adjuvant and the wide margin of safety indicates that JVRS-100 may be effective as a means to not only improve existing vaccines, but also to develop novel preventative and therapeutic vaccines against diseases for which vaccination has not been possible," said Grant E. Pickering, President and CEO of Juvaris.
"The promising results from this clinical trial indicate that JVRS-100 can increase the immune response generated by existing vaccines without additional toxicity," said Thomas P. Monath, MD, acting chief medical officer at Juvaris. "We look forward to advancing JVRS-100 into Phase 2 clinical development in the elderly patient population and into trials with a pandemic (avian) influenza vaccine. There are profound needs for adjuvants to improve vaccine efficacy and these study results will accelerate development of other novel vaccines incorporating the JVRS-100 adjuvant to address previously untreatable infectious diseases."
Seasonal influenza affects approximately one billion people worldwide each year, and results in 5 million severe illnesses and 500,000 deaths. Approximately 90 percent of the deaths occur in the elderly, where flu infection can lead to severe complications from underlying diseases, pneumonia and death. Seasonal influenza vaccines, which are widely used in the U.S. and developed countries are effective in only 30 percent of the elderly population. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines to improve efficacy and reduce vaccine dosage requirements.
JVRS-100 is a cationic lipid-DNA complex that is being developed as an adjuvant to improve the effectiveness of existing vaccines and to develop new vaccines against a variety of infectious diseases. Research indicates that the mechanism of action of JVRS-100 is distinct from other known adjuvants. The adjuvant complex self-assembles with disease-specific antigens and induces substantial antibody- and cell-mediated immune responses, particularly induction of CD4+ and CD8+ T lymphocytes. Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic vaccine settings in multiple species. This platform provides the opportunity to develop many disease-specific immunotherapy products for which there are significant unmet medical needs.
Adjuvants enhance the immunogenicity of antigens incorporated into vaccines. In addition, adjuvants can accelerate and prolong the immune response to vaccination as well as reduce the amount of antigen required per immunization. Adjuvants provide improved immunity to disease antigens by converting soluble protein antigens into particulates and/or by incorporating microbial constituents, which are able to improve antigen presentation and activation of signaling receptors associated with both the innate and adaptive immune response. Vaccines incorporating antigens alone, particularly inactivated vaccines and new generation vaccines based on recombinant and subunit proteins, are not sufficient to protect against or treat many global infectious diseases. Adjuvants will be critical to facilitate development of new vaccines against current and emerging disease pathogens.
Juvaris BioTherapeutics is a clinical stage company developing adjuvanted vaccines and immunotherapeutics to treat infectious diseases and cancer. The Company’s lead product candidate, JVRS-100, is currently in clinical development as an adjuvant to improve the efficacy of seasonal influenza vaccines in the elderly population. The Company is also developing proprietary vaccines for HSV-2, universal flu and pandemic flu and is initiating clinical development of an immunotherapeutic to treat acute leukemia with grant funding from a leading academic institution. Juvaris completed a Series A financing led by Kleiner Perkins Caufield & Byers and has been awarded multiple NIH grants. More information about the Company and its technology can be obtained at its website: www.juvaris.com.
Grant E. Pickering
Juvaris BioTherapeutics, Inc.
863A Mitten Road
650-259-1800 ext. 227