Sofie Biosciences, Inc. — Department of Health and Human Services SBIR Phase II: NCI

Description

PROJECT SUMMARY ABSTRACT Positron Emission TomographyPETis a molecular imaging modality that utilizes radiolabeled moleculesprobesto target and measure biological processesResearchers can use the same probes to examine microorganismscellsand mice as they do in patients to visualize and characterize the biology of diseasemonitor its progressionand evaluate therapeutic efficacyOverPET probes have been developed to help answer a variety of biological questionsbut only the glucose analogF FDG is routinely used for molecular imaging diagnostics in patient careThere is still an unmet need to develop additional probes which can annotate other key aspects of cancer biochemistryincluding those in which the diagnostics share common targets with drugsto truly establish it as a key technology for realizing improved treatment and monitoring in personalized medicineThe clinical translation of next generation PET probes is hampered by a lack of multi site infrastructure to robustlyreliablyand cost effectively support their supply to fulfill the initial data generation required to determine safety and efficacy in humansThis is often a key issue in bridging thegapbetween proof of concept research and FDA approvalPharma and Biotechwho face increasing pressure to use diagnostics to develop drugs more efficientlyrequire significant validation studies and a reliable supply to realize the value of a novel PET probe to their clinical program and invest in future studiesThusearly clinical studies in this gap are currently relegated to single site productionor must undergo a costand time prohibitive assimilation into a commercial radiopharmacy before they ve been clinically vettedTo facilitate a paradigm shift in the enablement of novel PET probes for the clinical trial communitya fundamental change in production ideology and infrastructure re imagining is requiredCreating a network of academic radiochemistry cores that standardize and share synthesispurificationformulationand quality control protocols through automation and cloud based applications for clinical production serves to reduce barriers to translating PET probes from the preclinical research environment to first in human studiesas well enable rapid dissemination of PET probes across multiple sites to spur and de risk academic and industry collaborationThe overall goal of this proposal is to establish and deploy a novellow costscalable approach to the clinical translation of a next generation PET probes for cancerstarting with candidate probeF CFAwith potential commercialization as a predictive response biomarker for cancer immunotherapies in solid tumorsi eCTLAPDblockadea pharmacodynamic biomarker for dCK inhibitorsand a predictive response biomarker for chemotherapy nucleoside prodrugs