IDBIOLOGICS INC — Department of Health and Human Services STTR Phase I: NIAID

Description

Our overarching goal is to develop a monoclonal antibody based product for the prevention of seasonal influenza in high risk patientsIt is estimated there aredeaths annually related to seasonal influenza worldwideIn the United Statestheinfluenza season was classified a high severity season withdeathsandhospitalizations attributed to influenzaserving as a reminder of the continued severity of influenza and the immense unmet needAt presentthe only approved drug for influenza prevention is the influenza vaccinewhich is available in multiple seasonally adjusted formulationsInfluenza vaccine effectiveness is poorranging fromtoMonoclonal antibodymABtherapeutics are in clinical developmentbut these are currently focused on treatment indications and not formulated to be practical for influenza preventionIn collaboration with the Crowe laboratory at Vanderbilt University Medical Centerwe propose to develop a combination of next generation mAbs that broadly and potently prevents seasonal influenzaThe backbone of the combination will be a novel class of fully human antiinfluenza mAbs that binds a highly conserved epitope in hemagglutininHAwith exceptional potency and breadth and acts through a new mechanismWhen used in combination with fully human mAbs against other antigenic sitesthis product can deliver a safe and effective vaccine like product profileIn this STTR Phase Iwe will establish the composition of the combinationin vivo efficacyand developability of lead mAbsenabling advancement of the optimized lead product in Phase IITo accomplish thiswe propose the following AimsAimIdentify the candidate components for a combination of human anti influenza mAbsWe will assess diverse anti influenza mAbs and combinations for breadth and potency to select components to be tested in AimWe have rationally selected mAb combinations to ensure noncompetitive binding of epitopes for neutralization testing against a panel of Hand Hinfluenza virusesAimDetermine in vivo efficacy of anti influenza mAb candidates and select leadWe will assess in vivo efficacy ofanti influenza mAb candidate combinationspre selected based on findings of AimWe will perform a series of influenza AH Nand H Nescalating dose mouse challenges studies using combinations of mAbs to select a single lead candidate and back upAimAssess manufacturing computational liability and identify candidate siblings with optimized performance and manufacturing computational liabilityWe will use a commercially available in silico sequence liability assessment platform to perform a multi parameter assessment of the manufacturability of the lead and back up candidates from AimAt the end of this Phase I SBIRwe will have established proof of concept for our optimized lead anti influenza mAb combinationand enabled Phase II studies to pursue full preclinical development of this lead IDBiologics proposes to develop a prevention for seasonal influenza infectionAlthough there is an influenza vaccineits effectiveness is lowleaving patientsparticularly the elderlyat risk for complications including deathTaking a page from the human immune systemwe are using monoclonal antibodies to attack the influenza virusby using the latest information about the virus and the latest technologies in antibody engineering