PAI LIFE SCIENCES INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

PROJECT SUMMARYLymphatic filariasisLFis one of only a small number of diseases classified as potentially eradicableInthe World Health Assembly passed a resolution to eliminate LF as a public health problem and the approach involved yearly concurrent mass drug administrationMDAto the at risk population incountriesAccording to the WHOaboutmillion people are at risk of acquiring LF and need annual MDA treatmentAfter nearlyyears of MDA to the at risk population and spending several billion dollarsthe incidence of LF infection has not significantly declinedThis is likely due to subject non compliance and lack of effectiveness of the drugs against the adult parasites living within the lymphatic systemThusreliance on the drug therapy approach alone is ineffective in limiting disease transmissionIn factchemotherapy only treats current infections and does not prevent future re infections leaving the patients susceptible to the diseaseSeveral recent studies show that the disease is reemerging in several parts of the worldThereforethere is a critical need for developing an effective prophylactic vaccine that can support the current MDA approach for preventing disease transmission and total elimination of the disease from endemic regionsUnlike most other infectious organisms such as virusesbacteria or protozoathe lymphatic filarial parasites do not replicate within their definitive hostsThereforethe prophylactic vaccine against LF need not induce sterilizing immunity to be effective for controlling the infectionIn factthe World Health OrganizationWHOhas determined that helminth vaccines that can prevent worm establishment bywill be effective in reducing overall morbidity and mortalityNone of these candidates of the past two decades have advanced beyond rodent testingpartially because of poor protection and or lack of resources to advance the technologyWe have developed and established the first successful multivalent recombinant fusion protein vaccineBmHAXTfor the prophylaxis of LFThe vaccine gives close to sterile immunity in rodents and significant protection in non human primateswhen given along with the TLRagonist GLA on alum adjuvantBmHAXT is now ready to move into the next phase of pre clinical development as a tag freerecombinant protein adjuvanted with the TLRagonist GLA on alumLFguardThusthe major focus of this project is toAimdevelop a reliabledependableand consistent manufacturing process for the tag free rBmHAXT GLA Alum vaccine formulationLFguardthat can be moved towards phasehuman clinical trials andAimto confirm that the newly developed LFguardvaccine formulation has similar or greater prophylactic potential than the his tagged BmHAXT research vaccine in experimental animal models PROJECT NARRATIVE This project aims to manufacture the first human helminth vaccine for lymphatic filariasisa gruesome disfiguring disease that affectsmillion people incountriesThe vaccineonce availablewill benefitmillion people who are at risk of acquiring the disease impacting global health