Symvivo’s bacTRL platform is a perfect fit to rapidly respond to current and future outbreaks of emerging infectious diseases. Our orally administered, genetically modified probiotic bacteria colonize the gut, bind directly to intestinal epithelial cells and constitutively replicate, secrete and deliver plasmid DNA molecules encoding antigenic transgenes and neutralizing nanobodies. Akin to natural viral infection, transgenic antigens are translated into proteins that localize to their natural cellular or extracellular locations in addition to being recycled and presented through MHC-class I activity. Durable multivalent antigen expression in the gastrointestinal lymphoid tissues initiate robust mucosal and systemic humoral and cell-mediated immunity, whereas expression of neutralizing nanobodies provide immediate passive immunity. As the vaccine constitutes a living-medicine, gene delivery rates are sustained throughout the life of the bacterial colony, resulting in extensive transgene expression throughout the epithelial lining. Presently, we are manufacturing, preclinically testing, and clinically evaluating a bifidobacteria monovalent SARS-CoV-2 DNA vaccine called bacTRL-Spike to rapidly induce both cellular and humoral immunity against Spike protein to prevent COVID-19 infection. Second, we are including the spike protein in addition to nucleocapsid protein and matrix glycoprotein for a trivalent vaccine called bacTRL-Tri. In addition, the third candidate is an immunoprophylaxis agent employing neutralizing nanobody encoding sequences for immediate infection protection.
Symvivo COVID-19 products are presented as oral lyophilized gel-capsules similar to traditional consumer probiotic supplements. As DNA transfection of colonic epithelial cells have been demonstrated to be immediate, immunoprophylaxis recipients should experience protective neutralizing antibody levels within hours and vaccine recipients should generate durable protective humoral and cellular immunity. The rapid manufacturing of large quantities with known, proven methods is very achievable. Symvivo’s bacTRL platform has the potential protect large populations from a wide range of emergent pathogens, through a unique combination robust and targeted transgene delivery technology coupled with the benefits of a readily customized, rapidly scalable manufacturing foundation.