TRACE-ABILITY INC — Department of Health and Human Services SBIR Phase I: 102

Description

ImmunoPETPositron Emission Tomographyhas been specifically identified in Blue Ribbon Panel reportpgas a transformative research recommendation for achieving Cancer Moonshot s ambitious goal of making a decade s worth of progress inyearsThe broad long term objective of this application is to expand availability of ImmunoPET from select few top tier research centers to the broad cancer patient population across the USThe main issue preventing such expansion today is rooted in production complexity of ImmunoPET tracersradioactively labeled antibodies used as contrast agentsThese activities are directly related to the mission of the NCITrace Ability proposes to automate the entire production procedure including radio labelingQC and immunoassay with results available before the PET scanProduction staff will need only to add the radionuclideinitiate the process and return to collect the product along with QC reportSuch solution will enable more facilities to produce ImmunoPET tracerseach facility to support more patients and fewer patients having to repeat scans due to low immunoreactivity of the tracerTracer QC is a radically innovative automated solution for QC of PET tracers based on integration of plate readerliquid handler and HPLC machineA kit of reagents and consumables enables hands free operationTracer QC platform will be used to automate the complete production process including synthesisQC and pre release immunoreactivityThe level of automation in the resulting system was previously inconceivable because traditional synthesis and QC processes rely on highly specialized procedures and cannot share system componentsNew capabilities that need to be enabled on Tracer QC for ImmunoPET applications are radiolabeling and immunoreactivity assayPET tracer chosen for this project isZr DFO Pembrolizumabtargeting PDreceptors expressed on the surface of activated T cellsproposed based on the breadth of its applications in cancer imagingSpecific AimDemonstrate feasibility of automatedZr DFO Pembrolizumab synthesis on Tracer QC platformRadiolabelingwhich falls outside of QC procedure scope has never been enabled on Tracer QCalthough it appears conceptually feasibleQuantitative milestonesaAutomated synthesis ofZr DFO Pembrolizumab starting withZroxalate finished using only Tracer QC and no manual operationsbRadiochemical yieldSpecific AimDemonstrate completeZr DFOPembrolizumab QC performed on Tracer QCQC of antibody based tracers includes tests similar to FDG plus a binding assay that takeshQuantitative milestonesaBinding affinity measured by TracerQC and traditional method agree withinbBinding assay completed in andlthourscDemonstration of all otherZr DFO Pembrolizumab QC measurements on Tracer QC By expanding availability of ImmunoPETPositron Emission Tomography imaging based on radiolabeled antibodiesto broad cancer populationproposed work enables timely and more educated treatment decisions that should lead to improved outcomesFurthermoreby dramatically simplifying production of radio labeled antibodiesthis project enables further research in ImmunoPET field as directed by the Cancer Moonshot Initiative Blue Ribbon Panel report