ISOPLEXIS CORPORATION — Department of Health and Human Services SBIR Phase II: 100

Description

With this PhasesubmissionIsoPlexis proposes to deliver a single cell proteomic solution for ultra sensitive detection of unique correlative biomarkers in pre clinical mouse modelsin an automated system that can be used to accelerate the discovery of potential immune therapeuticsThe recent revolution in new basic science discovery is failing to translate into improved patient treatmentThe reduction of new drug and biologic applications submitted to the FDA every year is directly due to onlyof promising preclinically approved treatments eventually advancing to marketAs the pharmaceutical biotech industry embarks on capitalizing on new immunotherapy discoveriesthe complex human immune system presents challenges to the development of new treatmentsWhile improved humanized mouse modelssuch as the Humanized Immune SystemsHISare a step forwarda need exists for an enabling biomedical technology to improve immune biomarker detection that de risks therapy selection translating to success in human treatmentA platform whichmeasures secreted protein polyfunctionality in a single cell platform for miceandgathers this data from limited mouse samples is necessaryThe technology should be able to measure multiplexedemergingprotein biomarkers that have proven critical to such immune therapies in humansdrastically improving clinical successWith the successes from the Phase I part of the projectIsoPlexis has developed such a high resolution immune response biomarker detection systemSCBCdelivering a comprehensive evaluation of the full polyfunctional protein secretion response of each immune cell to treatmentan analysis that has proven valuable in other immunotherapy arenasThis approach will maximize the potential data obtained from HIS mouse preclinical studies to advance the very best treatmentsThe two year project will accomplish the followingAimDevelop an integratedflow cellconsumable cartridgewith a andgtplex single cell protein panel to evaluate human T cell response in HIShumanizedmice and other genetically engineered mouse modelsGEMMsAimDevelop an automated system to enable the handling of limited murine sample size and increase assay throughputfor larger scale mouse screening studies in pre clinical laboratoriesAimsDemonstrate proof of concept utility of this technology across four trialsfor profiling polyfunctional response in HIS mice and other GEMMsadvancing biomarkers that lead to success in human treatments Given their spectacular initial successesimmunotherapy solutions are actively being sought for a wide range of diseasesbut run into the clinical challenges of inappropriate immune responsessuch as inflammation from Cytokine Release Syndrome or triggering of autoimmune diseaseIsoPlexis will deliver a system to detect unique correlative biomarkers for these treatments in pre clinical mouse models to select better treatments with fewer side effects prior to entering expensive clinical trialsThe IsoPlexis automated system will accelerate the discovery of potential immune therapeutics by providing detailed single immune cell responses to treatment and delivering greater value for each test from genetically engineered micesuch as the humanized immune system mouse models