MAPP BIOPHARMACEUTICAL, INC. — Department of Health and Human Services SBIR Phase II: NIAID

Description

PROJECT SUMMARY Mapp BiopharmaceuticalIncMappis developing antibody based therapeutics to treat a number of infectious agentsincluding some of the most dangerous known to manthe filovirusesMarburg virus is a filovirus endemic to Africa and causes an often lethal hemorrhagic feverPresently there are no approved vaccines or therapeutics to treat Marburg virus infections and this remains a major unmet medical needAlong with its collaboratorsMapp has screened overantibodies from a number of different species that bind to or neutralize Marburg virus in vitroSeveral of these have been shown to block the infection of cells and a few have shown potency when tested in animal models of MarburgRecentlyseveral fully human monoclonal antibodies have been identified and recovered from a Marburg virus infection survivorMRthe lead candidate and the focus of this proposalhas been shown to completely protect non human primates when challenged with a lethal dose of Marburg virus or the related Ravn virusMapp proposes to develop MRas a therapeutic candidate to treat Marburg and Ravn virus infectionsA Chinese Hamster OvaryCHOcell line to produce MRwill be createdcharacterizedand cell banks will be generatedThis cell line will support production of MRat a research scale that will be tested in a non human primate model of Marburg virus infection to determine the therapeutic windowi ehow late after infection can MRbe administered and still result inefficacyas well as dose determination studiesi ewhat is the lowest dose that givesefficacyAdditionallythe toxicity of MRwill be evaluated in non human primates and the data will enable the submission of a New Investigational Drug ApplicationINDto the U SFood and Drug AdministrationUpon completion of the scope of this projectMapp will be positioned to produce MRin compliance with current Good Manufacturing PracticescGMPsin advance of submitting the INDThis will enable the conduct of the first in human studies for this important filovirus MCM PROJECT NARRATIVE There are currently no approved medical countermeasures for Marburg virus infectionsThe efforts outlined in this proposal will aid in the development of a therapeutic drug candidate for treating and potentially preventing infection with Marburg virusSuccessful development of MRwill transform the medical options in the event of a natural outbreak or the intentional use of Marburg virus as a weapon