Juvaris BioTherapeutics' Vaccine Adjuvant, JVRS-100, Generates Superior T-Cell Mediated Immune Responses to Influenza in Clinical Trial
Data to be Presented at the 12th Annual Conference on Vaccine Research
Burlingame, CA – April 27, 2009
Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines and immunotherapeutics for infectious diseases and cancer, today announced clinical results demonstrating that its vaccine adjuvant, JVRS-100, when combined with a trivalent inactivated seasonal flu vaccine, generated robust T-cell mediated immune responses and antibody responses. Strong T-cell responses to influenza vaccine in humans have not been evidenced to date and remain an important goal for improved influenza vaccines particularly in elderly subjects. T-cell responses are critical to protection against influenza disease and recovery from infection.
Detailed results of the randomized, double-blind, multi-center Phase 1 clinical study will be presented at a podium presentation at the National Foundation for Infectious Diseases 12th Annual Conference on Vaccine Research meeting in Baltimore, MD, on April 27th, 2009 by Dr. Jeff Fairman, Vice-President of Research at Juvaris.
"The results from this trial confirm the results seen with JVRS-100 in pre-clinical studies, and the clinical data clearly support the broad potential benefits of an adjuvanted vaccine approach via the stimulation of both antibodies and T-cells, antigen dose reduction, single-dose administration, rapid immunity and improved cross-protection," said Grant Pickering, President and CEO of Juvaris. "We believe that JVRS-100 is ideally suited to address the unmet needs in the influenza market, including emerging threats such as the currently circulating swine flu, as well as to adjuvant other vaccines to treat infectious diseases where strong T-cell immunity is required."
In the Phase 1 study, 128 young adult subjects in groups of 20-24 were vaccinated with a licensed trivalent influenza vaccine with or without JVRS-100. The trial was designed to compare safety and immunogenicity 28 days after a single intramuscular immunization.
The efficacy endpoints were antibody measurements based on neutralizing and hemagglutination inhibiting (HAI) antibodies against the relevant flu virus strains, as well as T-cell responses measured by intracellular cytokine staining. Subjects receiving JVRS-100 adjuvanted vaccine were shown to have antibody responses to influenza A that were approximately two-fold higher than recipients of unadjuvanted vaccine. Importantly, significant T-cell responses, including polyfunctional T cells secreting multiple cytokines (interferon- , interleukin-2, and tumor necrosis factor- ) were observed in subjects receiving JVRS-100 adjuvant but not in subjects who received vaccine alone.
The primary safety objective of the study compared the safety and tolerability of JVRS-100 with vaccine vs. vaccine alone. The adjuvant was very well tolerated. The incidence of adverse events following vaccination with JVRS-100 at effective dose levels was similar to that in the vaccine-alone groups.
"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, M.D., 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. The elderly appear to have functional defects in plasmacytoid dendritic cell (pDC) responses during immune stimulation. Recent research data from Juvaris indicate that JVRS-100 can increase immune responses in the absence of pDCs, suggesting that the adjuvant will be effective in the elderly."
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 approximately one-third of the elderly population. The emergence of new, highly pathogenic strains, like the swine influenza virus currently affecting Mexico and the U.S., illustrate the need for improved vaccines. 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.
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 vaccines for HSV-2, universal flu and pandemic flu and has initiated 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.
866 Malcolm Road, Suite 100
Burlingame, CA 94010
650-259-1800 ext. 227