Vaccine Adjuvant

Phage’s proprietary peptide immunoadjuvant ligand is being developed to be administered in a composition containing the specific antigen of interest. The utility of the adjuvant has been studied in the animal model of the protection to anthrax.

Additional studies in animals funded by an NIH grant are getting underway at Duke University. Phage’s vaccine adjuvant can be applied to the prevention and treatment of viral, bacterial, and protozoan infectious diseases, such as HIV, malaria, tuberculosis, and leishmanias. Today’s vaccines are compounds which only activate man’s second line of defense (the adaptive immune system) and do not trigger the primary, innate immune system. There is a large unmet need for an adjuvant that can enhance both adaptive AND innate immunity, like the compound Phage is developing.

Phage Pharmaceuticals, Inc. is developing a family of mucosally administered cytotoxic T-lymphocyte (CTL) vaccine products for the prevention and treatment of pathogenic diseases and cancer. Phage’s technology is based on the novel discovery that key natural peptides stimulate CTL, elicit T-cell helper-1 (Th1) dominant immune responses, and enhance major histocompatibility complex (MHC) Class I restricted cross-presentation of non-infectious fragments of a pathogen or tumor associated antigen. Phage is seeking licensing partners to in-license specific uses of the adjuvant for infectious diseases and cancer in both man and animals. The utility of the adjuvant has been studied in the animal model of the protection to anthrax. Additional studies in animals funded by an NIH grant are getting underway at Duke University. The market competitors are compounds, which induce adaptive immune responses, but do not activate the primary protective innate immune response. There is a large unmet need for an adjuvant that can induce innate immunity.

A vaccine capable of producing a robust CTL immune response is essential to successfully prevent and treat diseases such as HIV. To date, attempts to induce a CTL response with adjuvants such as cholera toxin and cytokines have demonstrated limited success and can produce localized cytokine release syndrome. As a result, there is no approved vaccine capable of initiating an antigen-specific, Th1 dominant, CTL response.

Phage’s proprietary immuno-adjuvant ligand is administered in a composition containing the antigen of interest. The novel innate immune response of these compositions is based on the observation that activation of a specific family of regulatory transmembrane G-coupled protein receptors (GCPR) increases innate and adaptive immune surveillance for the co-administered antigen(s).

As part of the ligand-GCP receptor regulatory mechanism, receptor signaling can initiate a Th1 mediated immune response propagated by a pattern recognition receptor (PRR) genetically-programmed to elicit a cell mediated immune (CMI) response against the parent antigen. This response can include induction of CMI against a non-infectious antigen fragment of an otherwise infectious antigen.

There are at least 4 unique major epitopes of this ligand activated GCPR. These G-coupled protein receptors are naturally occurring regulators of cellular growth, repair, and apoptosis. This regulatory pathway is a highly conserved in nearly every vertebrate. Activation of the receptor up regulates the immunologic activity of immune cells (NK Cells, CD4+, CD8+, CD3, MØ, dendritic cells, and HPC (human progenitor cells).