Adjuvanted Vaccines

Seasonal Influenza: Juvaris is developing an adjuvant for seasonal influenza vaccines to improve the quantity and quality of immune responses achievable for the elderly population. Approximately 90% of the deaths occur in the elderly, where flu infection can lead to severe complications of underlying disease, pneumonia and death. The Company has completed a randomized, double-blind, well-controlled Phase I study (N=128) combining JVRS-100 with trivalent seasonal flu vaccine in normal, healthy adults. The adjuvant was deemed to be safe and showed improvement in both antibodies and T-cells.

Juvaris is currently conducting a randomized, well-controlled, double-blind Phase II study (N=472) combining JVRS-100 with trivalent seasonal flu vaccine in the elderly. That study is designed to demonstrate the adjuvant's safety and its ability to produce significantly better antibody and T-cell responses versus seasonal flu vaccine alone.

The worldwide incidence of seasonal influenza exceeds one billion cases annually resulting in 5 million severe illnesses and 500,000 deaths. Seasonal influenza vaccines are in wide use in the US and other countries, but have poor efficacy (25%-30%) in the elderly. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines to improve efficacy and reduce dosage requirements. The worldwide market for seasonal influenza vaccines was $2 billion in 2006, and is expected to double to over $4 billion by 2010 (Datamonitor, 2007). Growth in this sector is driven by expanded CDC recommendations for vaccination, an aging population, and increased awareness.

Pandemic Influenza (Avian-H5N1): Juvaris is developing an adjuvant for pandemic influenza vaccines against avian influenza H5N1 to produce single-dose protection, efficacy against drifted and shifted strains and to reduce dose requirements. Influenza pandemics occur when the influenza virus recombines with an animal influenza virus to produce a new or "shifted" strain against which humans have no immunity. An influenza pandemic could have devastating consequences that could result in a 2- to 10-fold increase in the number of influenza cases and deaths. Because of the emergence of a new virus strain, the human population has no pre-existing immunity and is, therefore, highly susceptible to infection. The avian flu case fatality rate of ~60% is 100-fold higher than the .06% mortality rate of the H1N1 or "swine" flu. Due to the high level of travel in the modern world, a new influenza virus strain can spread domestically and internationally in a very short time frame and therefore influenza is a continuing major threat. While it is impossible to predict the emergence of a pandemic flu and the causative strain, the economic and human impact could be catastrophic. The Juvaris adjuvant has been shown to increase the effectiveness of the current pandemic influenza vaccine by increasing immunogenicity to matched strains and also providing cross-reactive antibodies to drifted strains of the avian flu virus (H5N1).

Herpes Simplex Virus-2 (HSV-2): Juvaris is developing a novel proprietary adjuvanted prophylactic HSV-2 vaccine employing multiple antigenic constructs. HSV-2 is a member of the herpesvirus family, and is the leading cause of genital herpes. In the US, approximately 50 million people (20%-30%) have genital herpes infection and new infections occur at a rate of approximately one million per year. HSV-2 infections are chronic and result in viral shedding in both symptomatic and asymptomatic individuals. Antiviral regimens have become a standard of care in the treatment of the HSV-2 infection. The necessity for daily administration and the high cost during the lifetime of the patient exemplifies the need for alternative preventative methods for reduction of HSV-2 viral shedding and transmission to uninfected individuals. HSV-2 positive individuals are also at a five-fold higher risk of contracting HIV versus those that are uninfected. A JVRS-100 adjuvanted vaccine has demonstrated substantial and long-term protection in the guinea pig HSV-2 infection model, the established standard for assessing pre-clinical efficacy.

Universal Influenza: Juvaris is developing a novel, proprietary adjuvanted universal influenza vaccine employing conserved antigenic epitopes for both Influenza A and Influenza B strains. The objective of a universal influenza vaccine is to improve the reliability and quality of protection by raising cross-protective immunity to all strains of influenza. A universal vaccine could be stockpiled and utilized year after year without the need to prepare an annual seasonal vaccine, and would protect against epidemic virus strains mismatched with the annual seasonal vaccine (currently a common occurrence) and new pandemic strains that may arise before appropriate vaccines can be developed.

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