Technology Platform
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. 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 infectious diseases.

Overview of the Immune System
The immune system provides a multi-faceted natural defense mechanism in mammals against invading infectious pathogens, such as bacteria, viruses and parasites and also plays a critical role in recognizing and preventing abnormal cell expansion such as cancer. The immune system is comprised of a variety of cell types and soluble factors, working in concert, to generate an immediate (hours to days) first-line response to pathogens, termed innate immunity as well as a more specialized longer duration (weeks) response, termed adaptive immunity.

The innate and adaptive immune responses represent separate, but coordinated immunological pathways by which the body defends itself against disease. Phagocytic scavenger cells (macrophages and dendritic cells) recognize and engulf foreign invaders that enter or arise in the body and when activated, these cells produce substances (cytokines) that alert other cells of the immune system to the presence of the infectious agent or abnormal cells. The activation of the innate immune response initiates an immediate cascade of immune-related events to stop the initial infection. In addition following phagocytic digestion, various components (i.e., proteins, peptides, etc.) of the invading organism or abnormal cells are presented  by antigen-presenting cells (dendritic cells) to specialized immune modulatory helper T lymphocytes, called Th1 and Th2 cells, which become specifically activated. The Th1 and Th2 cells subsequently interact with the primary immune effector cells, T lymphocytes and B lymphocytes of the adaptive immune response, and ultimately develop into antigen-specific cytotoxic T killer lymphocytes (CTL) and antibody-producing cells, respectively.

Viruses, bacteria, and cancer cells generally activate Th1 responses, whereas, parasitic infection triggers a Th2 type of response. The Th1 response leads to the production of specific cytokines that include interferons (alpha, gamma) and interleukin-12 (IL-12) as well as the activation of natural killer (NK) cells and CTL. In contrast, Th2 response activation results in the production of a different group of cytokines (IL-4, IL-5 and IL-13) that attract inflammatory cells, which eliminate parasites as well as leads to the production of a specialized type of antibody, IgE, associated with allergic types of reactions. The Th1 response is believed to be the most potent immune response the body can generate against diseases (viruses, bacteria, and cancer).

Innate immunity develops rapidly in the face of pathogen invasion resulting in a generalized short-term immune (i.e., cytokine) activation. In contrast, the adaptive immune response requires a longer period of time (days to weeks) to become sensitized, expand, and differentiate into mature immune effectors, but results in a more highly specific and powerful activity conferring long-term immunity. Under normal conditions, the innate and adaptive immune pathways provide an immune surveillance and protection function for the body.

Many pathogens and cancer cells, however, have evolved mechanisms (i.e., mutations, immune suppression) to evade or hide from the immune system and, in this manner, chronic infectious diseases and cancers are able to establish themselves. Current vaccines are generally administered prophylacticly, i.e., before encountering the disease agent, and are primarily designed to produce specific antibodies that are able to clear the invading pathogen before it can infect the host. However, treatment of established diseases (e.g., chronic infections and cancer) requires a much more powerful immune response to overcome the existing disease process, not only by better recognition of the disease target, but also through more effective elimination of the causative agent. Scientists generally agree that the CD8+ CTL response is critical for eliminating established diseases such as cancer and chronic infections. Therefore, efficient and broadly effective therapeutic immunostimulants are essential to boost these specialized immune effector systems in the context of an ongoing disease process.

The Juvaris technology platforms, JuvImmune^TM and JuvaVax^TM, are designed to meet this challenging immunotherapeutic medical need. The Juvaris vaccine platform can be employed for either prophylactic (disease prevention) or more challenging therapeutic (disease treatment) applications. The synergistic combination of lipid and non-coding DNA, with or without disease-specific antigens, provides a unique and potent immunological stimulus, which activates substantial Th1-mediated responses. This immunological activation results in the generation of superior CTL and antibody-mediated immune responses, making the technology very appropriate for therapeutic purposes. The Juvaris therapeutic vaccine platform provides an enhanced immune stimulation of both the innate and adaptive immune responses to create a powerful immunotherapeutic approach for the treatment of cancer and chronic infectious diseases.