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Juvaris Beotherapeutics, Inc.

Juvaris BioTherapeutics Initiates Phase I Clinical Trial of JVRS-100 Adjuvanted Seasonal Influenza Vaccine

Burlingame, CA - May 28, 2008

Juvaris BioTherapeutics, Inc., a biotechnology company developing therapeutics and adjuvanted vaccines for infectious diseases and cancer, today announced the initiation of a Phase 1 clinical trial of its lead compound, JVRS-100. The trial will compare the safety, tolerability and immunogenicity of the JVRS-100 adjuvant co-administered with a commercial influenza vaccine compared to vaccine alone.

"JVRS-100 has demonstrated the ability to significantly increase immune responses of existing vaccines in preclinical studies, providing a potential opportunity to improve influenza vaccine efficacy," said Grant E. Pickering, President and CEO of Juvaris.  "This double blind trial will evaluate varying dose amounts of JVRS-100 and is designed to provide safety information, dose determination and the primary immunological response data used to determine efficacy for adjuvanted vaccines. While one influenza vaccine will be used in the study, we believe the results will inform about the broad applicability of JVRS-100 for use with many available vaccines."

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.  Seasonal influenza vaccines, which are widely used in the U.S. and developed countries, have modest effectiveness in children and young adults, but are effective in only 30 percent of the elderly population. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines in order to improve efficacy and reduce vaccine dosage requirements due to supply constraints.

"There is a great need to improve upon the efficacy of influenza vaccines particularly given their ineffectiveness in the elderly, who stand to benefit the most from vaccination, but unfortunately receive the least amount of protection," said Eric A. Sheldon, M.D., Medical Director and Director of Vaccine Development at Miami Research Associates and an investigator for the Juvaris trial. "The JVRS-100 adjuvant has demonstrated promising preclinical activity and we look forward to evaluating this candidate in a randomized Phase 1 trial."

The randomized, double blind, controlled Phase 1 trial is expected to enroll 128 healthy subjects in four treatment cohorts. The study will evaluate a licensed trivalent, inactivated, split influenza vaccine with ascending dose levels of JVRS-100 compared to the vaccine alone.  JVRS-100 will also be studied with reduced doses of the influenza vaccine to assess its effectiveness and vaccine dose-sparing effects. Primary objectives of the study are to assess the safety and tolerability of the JVRS-100 adjuvant and its ability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine.

About JVRS-100
JVRS-100 is a toll-like receptor-directed cationic lipid-DNA complex that is being developed as a therapeutic and an adjuvant to treat multiple diseases.  JVRS-100 has been shown to be at least 50-times more potent at triggering innate immune activation and interferon release than current immune stimulants indicating its potential to treat multiple infectious diseases and cancers.  When combined with disease-specific antigens, JVRS-100 is 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 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.

About Adjuvants
Adjuvants are used to enhance the effects of a vaccine by stimulating the immune system to respond to the vaccine more robustly, providing improved immunity to disease by stimulating antigen presenting cells such as dendritic cells (DCs), lymphocytes and macrophages.

About Juvaris
Juvaris BioTherapeutics is a clinical stage company developing a platform of toll-like receptor-directed therapeutics and adjuvanted vaccines to treat infectious diseases and cancer. The Company’s lead product candidate, JVRS-100, is currently being evaluated as an adjuvant to improve the efficacy of seasonal influenza vaccines. The Company plans to initiate additional clinical studies with JVRS-100 in hepatitis C and acute myelogenous leukemia.  Juvaris completed a $12.3M Series A financing led by Kleiner Perkins Caufield & Byers and has been awarded multiple NIH grants including a recent award for approximately $9M to develop adjuvants for influenza vaccines. The Company also recently announced a major world-wide licensing agreement for Juvaris technology’s use in the animal health field with Bayer Healthcare AG.  More information about the Company and its technology can be obtained at its website: www.juvaris.com.

Company Contact:
Grant E. Pickering
Juvaris BioTherapeutics, Inc.
863A Mitten Road
Burlingame, California
650-259-1800 ext. 227
gpickering@juvaris.com

© 2014 Juvaris BioTherapeutics.