Juvaris BioTherapeutics was created in response to the breakthrough finding that cationic lipid-DNA complexes (JuvImmune^TM) are 10 to 50-times more potent at triggering immune activation and interferon release than current, best known immune stimulants. (Figure 1)

JuvImmune^TM
The immunological responses elicited by JuvImmune^TM have been successfully demonstrated in a variety of mammals including mice, rats, rabbits, cats, dogs, goats, and monkeys. The company's initial product focus is based on immunotherapeutic applications for cancer and chronic infectious diseases.

JuvImmune^TM has been demonstrated to induce immunological responses capable of reducing tumors in animal models with well established pre-existing tumors. (Figure 2)

JuvImmune^TM has also demonstrated efficacy in dogs with spontaneously occurring tumors that have failed prior chemotherapy.

The JuvImmune^TM system, employing a non-coding plasmid and lipid-based complex, offers substantial advantages over oligonucleotide-based immunotherapeutics including simplicity of construction and formulation, reduced cost of production, dose efficiency and potency, and broad activity in multiple species by a variety of administration routes.

Juvaris BioTherapeutics aims to commercialize JuvImmune and offer superior products as anti-bacterial, anti-viral and anti-cancer therapeutics, and as a potent, broadly applicable vaccine adjuvant.

JuvaVax^TM
Juvaris has also discovered that the JuvImmune^TM system can be combined with specific antigens to produce extremely effective disease-specific vaccines. These lipid-antigen-DNA complexes (JuvaVax^TM) are remarkably effective at inducing T cell responses with very low antigen doses. The T cell responses induced by JuvaVax^TM vaccines are more potent than responses elicited by conventional approaches, including dendritic cell and viral-vectored vaccines. (Figure 3)

An equally striking feature of JuvaVax^TM vaccines is their ability to induce pronounced CD8+ T cell responses against protein antigens, a property that few other vaccines possess. These CD8+ cytotoxic T lymphocyte (CTL) responses are critical for effective immunity against viruses, intracellular bacteria and tumor cells.

In addition, JuvaVax vaccines activate strong antibody responses that are equivalent to those elicited by Freund's adjuvant without the unwanted side effects. Furthermore, JuvaVax^TM has been demonstrated to elicit potent antibody responses against immunologically challenging polysaccharide antigens.

JuvaVax^TM has also exhibited the ability to be effective in an immunocompromised [e.g., CD4 knock-out, T-cell deficient] mouse model (Figure 4). This remarkable finding suggests the specific activation of the CTL immune response, independent of mature CD4 T cell helper function, which supports the concept that the Juvaris immunostimulant could be employed in immunocompromised-patient clinical situations (e.g., HIV, cancers).

The original discovery by the Juvaris founders has now been confirmed by several years of pre-clinical research and clearly represents a new frontier in vaccine design. The recognition that there is a synergistic effect of combining nucleic acids complexed with lipids and low antigen doses to produce a very potent immunostimulatory response, provides a compelling opportunity for development of a new generation of therapeutic vaccines. The Juvaris technology platform comprised of antigens (e.g., peptides, proteins) combined with the lipid/DNA complexes can potentially provide a robust and specific immune response-generating capability that is significantly greater than any existing technology.