ACCELEVIR DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase II: NIAID

Description

Project Summary AbstractHuman immunodeficiency virus typeHIVis a retrovirus that infects CDT cells of the immune systemIf left untreatedHIVinfected individuals will progress to AIDS and may ultimately die as a resultCombination antiretroviral therapy is extremely effective at stopping the replication of HIVin infected individualsDespite the success of this therapy at suppressing HIVreplication to clinically undetectable levelsantiretroviral therapy is not curativeThis is due to the persistence of HIVin a silentor latentstate within a subset of CDT cells known as resting memory CDT cellsIn this latent statethese infected cells are not targeted by antiretroviral drugs and cannot be eliminated by the immune systemIn HIVinfected individualslatently infected CDT cells are found at extremely low frequenciesper million resting memory CDT cellsHoweverthis population of latently infected cells is very stabledemanding that HIVinfected individuals remain on antiretroviral therapy indefinitelyThereforethis population of latently infected CDT cells is the main barrier to curing HIVinfectionDeveloping strategies to eliminate latently infected cells is a major focus of the NIHNIAIDand the HIVresearch fieldTo demonstrate the efficacy of therapeutics targeting the latent reservoirwe must be able to measure the frequency of latently infected cells using rapid and accurate assays that can be scaled for widespread clinical useHoweversuch assays are not currently availableAccelevir DiagnosticsLLC is therefore developing a new molecular assay to accurately measure the size of the latent reservoir by quantifying the number of intactreplication competent proviruses present in CDT cells from HIVinfected patientsBroadlythis proposal aims to define critical assay kit controlsperform analytical validation studiesbenchmark our novel assay against available research assays for latent HIVcollect baseline data from HIVinfected individuals on suppressive therapyproduce commercial prototype kits for beta testingand develop a data analysis framework for assay readouts and associated clinical metadataThe overall goals of this proposal are to complete development of our commercial test for latent HIVand collect the foundational performance data needed to enable market entry!Project NarrativeFor HIVinfected individuals on suppressive antiretroviral therapylatent HIVinfection of resting memory CDT cells is the major barrier to a cureElimination of these latently infected cells by has been proposed as a strategy to cure infected individualsThis proposal details the development and optimization of a new molecular assay to measure the number of latently infected cells in patients by Accelevir Diagnosticsfor use in monitoring the efficacy of HIVcure therapies