AbstractBackgroundThe ever increasing list of broad adverse medical conditions associated with Porphyromonas gingivalis (Pg) infection associated with the long term, oral, biofilm‐associated colonization in humans leading to a state of chronic systemic inflammation with multiple organ system diseases (atherosclerosis, cardiovascular, stroke, diabetes type 2/metabolic syndrome, cancer, Alzheimer, etc.), stands in stark contrast to a grossly lacking set of effective treatments and/or prophylactic interventions.MethodUsing multiple technologies in microbiology, protein chemistry, proteomics, molecular biology, nucleic acid and protein sequencing, immunochemistry, scanning electron microscopy, biologics development, mid and large scale up hybridoma monoclonal antibody production and human chimeric antibody development and enzymology, an updated status of a newly developed precision biological will be presented.ResultKB‐001 a murine IgG1 binds directly to a unique hetero‐multimer antigen involved in the bacterial cargo IX transporter secretion protein complex through a high affinity bi‐valent binding (kD 10‐8‐9). About 40‐60 antibody molecules bind to emerging OMVs per bacterial are observed. In addition isolated OMVs demonstrate binding to the outer and inner membranes. Mechanism of action studies demonstrate that the antibody interferes with the proteolytic processing of the larger parent protein required for subsequent endo‐peptidase activity and assembly. More specifically, the binding of antibody to this complex prevents the maturation of the gingipains/LPS endo‐protease/peptidase system‐needed for its absolute survival and the production of its secreted outer membranes vesicles (OMVs) responsible for the majority of its systemic multi‐systems pathology. In an earlier human clinical trial, following its topical oral administration in advanced Pg infected periodontal patients, long term (12 months) prevention of re‐colonization of P. gingivalis following standard dental therapy was observed. In addition, the paratope binding domain from this murine Mab was successfully grafted onto a human IgG1 framework thus creating a second generation human‐chimeric, bio‐therapeutic antibody.ConclusionThese data now demonstrate the two precision bio‐therapeutics could be valuable for treating and/or preventing P. gingivalis infection in humans.