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

Description

Project Summary AbstractThe annual estimated burden of malaria has increased toM clinical episodes anddeathsand annual losses of andgt $B of GDP to malaria in Africa aloneThe world needs a malaria vaccineSanaria s Plasmodium falciparum sporozoitePfSPZvaccines have protectedof subjects against controlled human malaria infectionCHMIin five clinical trials in the U SGermanyTanzaniaand Maliprotected adults at least formonths against intenseheterogeneous transmission of Pf in two clinical trials in Maliand are now being assessed in clinical trials inmonths toyear old s inAfrican countries and in adults inEuropean countries as well assites in the USThe plan is to initiate the first Phaseclinical trials to support submission of a Biologics License Application to the FDA in the US in the second half ofand in Africa in the first half ofSanaria s PfSPZ based vaccines contain asepticpurifiedcryopreservedlive Plasmodium falciparumPfsporozoitesSPZthat are manufactured in aseptically reared Anopheles stephensi mosquitoesThe current method of aseptic mosquito productionwhile robust and reproduciblerelies heavily upon manpower and large quantities of expensive consumablesand requires significant spaceSemi automation of mosquito dissection to remove salivary glands developed under another SBIR grant is expected to increase the efficiency of the process tomosquitoes per hour per operator in the first half ofThusproduction of mosquitoes is now the bottleneck and most expensive step in the GMP manufacture of PfSPZ vaccinesThe overarching aim of this project is therefore to develop methods to reduce manpower and consumable costs and overall space requirements by developing a semiautomated system for culturingmanufacturingaseptic mosquitoesIn specific aimwe will designbuild and test a bioreactor for hands freeaseptic culturing from eggs to larvae to adult mosquitoesThis bioreactor will be developed tomeet all GMP requirementsremove the need for expensive consumables to increase outputreduce human costseliminate the need for many of the biological safety cabinets used in mosquito productionandbe adaptable for eventual removal of incubators from mosquito productionWe will demonstrate that the new bioreactor is capable of maintaining the critical aseptic environment for the larval culturesand that the mosquitoes raised in the larval bioreactor show equivalence with those produced by current methodsIn specific aimwe will develop apparatus for automated harvesting of adult mosquitoesOur aim is to be able to transfer newly emerged adult mosquitoes directly and hands free from the larval bioreactors into big aseptic mosquito containers in which the mosquitoes will be fed upon gametocytes and maintained until the day of extraction of PfSPZ from mosquitoesDeveloping the larval bioreactor will lead to a sea change in Sanaria s capacity to manufacture its PfSPZ productsputting Sanaria on track for mass scale manufacturing at phaseGMP compliance at a significantly reduced cost PROJECT 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 transmissionBoth Plasmodium falciparumPfsporozoiteSPZVaccinePfSPZ Vaccineand PfSPZ chemoprophylaxis vaccinePfSPZ CVacprovide durableprotective immunity against controlled human malaria infectionCHMIAs manufacture of PfSPZ Vaccine moves into phaseand launchthe manufacturing must be scaled upBoth PfSPZ Vaccine and PfSPZ CVac are manufactured in aseptically reared mosquitoesThis proposal aims to develop a unique bioreactor system that will support the aseptic rearing of mosquitoes in a hands freesemi automated unitSuccess in this project will allow massive scale up of mosquito production in support of the manufacture of PfSPZ vaccinesand simultaneously greatly reduce cost of goods