Lead Candidate Finalization and a Comprehensive Biological Assessment of a New Class of Pneumococcal Vaccines

PROJECT SUMMARYThe illnesses caused by Streptococcus pneumoniaeandapos s transition from carriage to disease results in a mortality rate between approximatelyin adults andin elderly patients in the United StatesFurthermorepneumococcal disease devastates resource poor countriescausing an estimatedof vaccine preventable deaths in children below age fiveto succumb to pneumococcal infection annuallyThe most effective vaccinespolysaccharide protein conjugatesrequire a complicated process of collecting polysaccharide antigens from pneumococci serotypes and conjugating them to a protein adjuvantAbcombi Biosciences has developed a pneumococcal vaccine using liposomal encapsulation of polysaccharidesLEPSwhich has demonstrated conjugate like efficacy againstserotypes of Spneumoniae via animal challenge models and opsonophagocytosis activityOPATo our knowledgethis represents the broadest protection demonstrated by a conjugate like vaccine to date using an OPA assaywhich is recognized as the gold standard for clinical efficacy against SpneumoniaeIn the proposed Phase I applicationAbcombi Biosciences outlines a plan to overcome the risk for potential negative side effects associated with the LEPS vaccineandapos s current formulationBrieflythe inclusion one pneumococcal virulent proteinGlpOand his tags creates the potential for off target effectsIn this approachserum from GlpOvaccinated mice will be evaluated for cross reactivity against a representative set commensal microflora using immunofluorescence and OPA assaysIn additiona portfolio of protein to liposome attachment strategies will be immunologically characterized by quantifying antibody titersantibody class shiftingand OPA activityUpon completing these studieswe will consult with our CMC and regulatory advisors to select the most promising candidate for long term manufacturingThis candidate will then be subjected to a comprehensive immunological and toxicological assessment in preparation for IND enabling studiesThis work will serve as the basis for process optimization studies that will be conducted in a future Phase II study PROJECT NARRATIVEThe proposed Phase I project will build upon the effectiveness of polysaccharide and protein for vaccination applications in pneumococcal treatmentSuccess will provide a clinically viable vaccine formulation capable of the broadest protection against pneumococcal diseasee gpneumonia and middle ear infectionand the continued progress of commercial translation