Flu vaccine for elderly JRV-100 in clinical trials: Juvaris Biotherapeutics

JVRS-100, a seasonal influenza vaccine for the elderly from Juvaris BioTherapeutics, Inc is currently undergoing human studies.

Juvaris BioTherapeutics, Inc has begun enrolling patients in a Phase 2 clinical trial of its lead compound, JVRS-100, as an adjuvant for seasonal influenza vaccines in the elderly population.

“There is a significant need to improve the efficacy of seasonal influenza vaccines for elderly individuals given that current vaccines are effective in only a fraction of this population,” said Tom Monath, M.D., acting Chief Medical Officer of Juvaris, in an official release.

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.

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.

JVRS-100 enhances both antibody and T-cell mediated immune responses in both prophylactic and therapeutic vaccine settings in multiple species and thus holds potential for the development of improved influenza protection, especially in a population more susceptible to complications from influenza infection,results from our first clinical trial demonstrated that JVRS-100.

Moreover, this was the first time an adjuvant has shown the ability to induce CD8+ cytotoxic T-cells in humans. This finding has broad implications for development of new vaccines against infectious diseases and cancer, Tom Monath stated.

JVRS-100 has been studied in randomized, double-blind, controlled trial will enroll approximately 472 subjects 65 years and older and compare antibody and T-cell responses to trivalent inactivated influenza vaccine administered with and without the JVRS-100 adjuvant.

JVRS-100′s study’s primary objectives of the study are to assess its safety, tolerability and ability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine. The study is also intended to define the most effective dose of the JVRS-100 adjuvant and will evaluate three different doses. Enrollment will take place at six centers across the United States.

JVRS-100′s phase 2 trial in the elderly will yield proof-of-concept for JVRS-100 in this underserved patient population, Juvaris said.

Juvaris expects to complete in mid-2010.

Seasonal influenza affects approximately one billion people worldwide each year resulting in 5 million severe illnesses and 500,000 deaths.

Approximately 90 percent of deaths occur in the elderly. Seasonal influenza vaccines, which are widely used in the U.S. and developed countries, are generally effective in children and young adults, but are effective in only 30-50 percent of the elderly population.

Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines in order to improve efficacy and reduce vaccine dosage requirements.

Juvaris BioTherapeutics is a clinical stage company developing adjuvanted vaccines to treat infectious diseases.

Apart from JVRS-100, Juvaris is also developing vaccines for HSV-2, universal flu and pandemic flu.

Juvaris recently closed a Series B financing led by SV Life Sciences along with existing investor Kleiner Perkins Caufield & Byers.