Peter Nara
KEYSTONE BIO is a highly compact PharmaBiome company focused on the newly emerging oral-systemic healthcare market(s). More specificly the company is bringing a bio-therapeutic (“Preveventtm”-monoclonal antibody) through pre-clinical development and clinical trials. The biotherapeutic will address an unusaual disease paradigm of a single bacterial agent (Keystone pathogen) that following infection is capable of inducing a set of interelated multi-systems inflammatory disease processes throughout the body. A specific keystone bacterial pathogen (Porphyromonas gingivalis), of oral origin and community acquired over decades of life, plays a key role in the establishment of a chronic lifelong infection of the oral cavity-more specifically the subgingiva (gums). This infection leads to additional recruiting of other red complex anerobic bacteria that then form a poly-microbial dysbiotic biofilm that eventually after many years attack the gums and teeth locally. By this time the locally oral silent infection has progressed to visual gum disease it has been causing continuous major systemic vascular inflammation without fever and found assocaited with a multi-systems disease profile in humans (e.g. atherosclerosis, CVD/CAD, Alzheimer’s disease, stroke, NASH, TD-2 diabetes, esophageal, lung, colon and pancreatic cancers, glioblastoma and rheumatoid arthritis). The monoclonal has been shown in its first clinical study, a study designed to evaluate its role in periodontal disease, to be safe and highly effective in eliminating the bacteria with a few closely spaced oral topical treatments (INFECTION AND IMMUNITY, Vol. 64, No. 2 1996). The IgG1 monoclonal antibody is directed at the surface hemagglutinins of P. gingivalis and recognized by the antibody that include RgpA (Gingipain R1; also known as prpR1 or hemagglutinin HagE), Kgp (Lys-gingipain) and HagA (Hemagglutinin A). The phase 1 and 2 clinical trials will first address the well-defined area of its association of CAD/CVD.