SANARIA INC. — Department of Health and Human Services SBIR Phase II: NIAID

Description

ABSTRACT Sanaria s Plasmodium falciparumPfsporozoiteSPZvaccines development program is receiving overwhelming global supportEleven trials of Sanaria s two primary PfSPZ vaccines which includesubjectswere initiated in lateTanzaniaU Sor will start in earlyKenyaGhanaEquatorial GuineaEGBurkina FasoGermanyand the U SThese trials will assesstodose regimens based on a trial in Germany showingprotective efficacy against controlled human malaria infectionCHMIweeks after the last dose of adoseweek regimenProtective efficacy is durable against CHMI for at least a yearand against intense natural transmission in Mali for at leastmonthsThis success has led to the developmentin collaboration with the International PfSPZ Consortiumof astage clinical development planThe completed trialsstageand above mentioned new trialsstageare intended to optimize immunization regimens in preparation for pivotal phaseclinical trialsstageto support a Biologics License ApplicationBLAto the FDA and commercializationlaunchStagepost licensureincludes a mass vaccine administrationMVAcampaign to halt transmission of Pf and eliminate the parasite from the andgtpopulation of Bioko IslandEGThrough SBIR grants and U Smilitary contractsSanaria is scaling up manufacturing and improving its vaccine manufacturing facility to meet phaseand launch complianceHowever there are critically importantunfunded components of our quality assuranceQAquality controlQCmanufacturingregulatoryand clinical quality and data management programswhich must be upgraded and finalizedThis CRPP project will address several of these key componentsThe overarching goal is to augment Sanaria s current efforts to achieve commercialization readiness and optimize chances of a successful phaseprogramBLAproduct launchand post launch phasetesting and maintenanceWe willEstablish and implement a QA and QC program that meets harmonized regulatory standards with appropriate organizational and systems infrastructureFormally assess manufacturing processesincluding Failure Modes and Effects AnalysisFMEArisk assessment and validation of the aseptic manufacturing processesTransition to regulatory submissions in electronic common technical documenteCTDformatestablish a platform for hosted regulatory document managementdevelop a strategic framework for FDA submissions and interactionsand develop and implement plans for BLA submission and regulatory SOP completionandDevelop phasecompliant clinical quality systemsincluding clinical SOPsestablish a CDISC compliant clinical data management platformimport data from clinical trialsgenerate Clinical Study ReportsCSRsfor all clinical trials lacking CSRsand conduct a quality review audit of trial master filesFunding of this proposal will significantly shorten the time until product licensure and launchwhich will lead to sales and income at least a year earlier than otherwise possibleand will save many lives PUBLIC HEALTH RELEVANCEProject NarrativeMalaria afflicts over two billion peoplekilling overindividuals each year mostly children in AfricaA powerful tool is needed for eliminating Plasmodium falciparum malaria from defined geographical areasThe ideal tool would be a highly effectivelong acting vaccine that prevents infectiondisease and parasite transmissionthe SanariaPfSPZ Vaccine is the leading candidate that fits these characteristicsThis proposal will accelerate to market Sanaria s PfSPZ Vaccine by providing support for Quality AssuranceQuality ControlManufacturing complianceregulatory and clinical QA and reportingThis support will allow the submission of BLAs for the vaccine and post licensure management