Eutropics Pharmaceuticals, Inc. — Department of Health and Human Services SBIR Phase II: 102

Description

Abstract The Eutropics PraediCare Dxis an emerging clinical diagnostic assay that will be used to predict patient response to specific chemotherapiesUnlike existing assaysPraediCare Dxpredicts response to specific chemotherapies by direct evaluation of cancer cells potential to enter into an apoptotic state following exposure to therapyPraediCare Dxhas the potential to provide actionable data for guiding the use of available treatment options in numerous cancersThe current iteration of the PraediCare Dxtest measures the functionality of the mitochondriaMitochondria are the key energy providers within the cell and disruption in their function to signal impacts susceptibility to chemotherapy induced cell deathOur functional biomarker approach has proven predictive value in several blood cancersThe assay is currently being used as a stratification tool to guide clinical treatment in Acute Myelogenous LeukemiaAMLIf successful the test will become a Cdx for that treatment and a partnership with the pharma company is now in placeIn additionthe platform has been used in Chronic Lymphocytic LeukemiaCMLand Multiple myelomaMMclinical studies and will be used to guide treatment in those indicationsThe company is now in position to provide tailored algorithm readouts as stratifying tools for different clinical trialsLicensing agreements for each Cdx algorithm will provide near term revenuesIn addition the clinical test for standard of care has been verified in two separate studies and is nearing commercial launchEutropics is also preparing related clinical tests as treatment specific biomarkers for prostatebreastlung and pancreatic cancersThis next generation PraediCare Dxplatform is now in development and we are in discussions with several pharma companies about partnering the new formatinitially for RUO use Narrative Given the large amount of phenotypic and genetic diversity in AML and MMthe need for predictive tests that can accurately guide use of the growing number of new treatment options is pronouncedThe information held in the genetic makeup of the individual and the individual s tumor holds enormous informationand new technologies have made mining that information practical and amenable to clinical applicationThere is clearlythough clinically relevant information about the non geneticepigeneticphysiologic state of the cancer cell that is available through measurements using various other methodsThis information may prove to be additive to genetic measurements to improve sensitivityor may provide better biomarkersPraediCare DxTM assay determines the functional sensitivity of cancer cells to cell death to accomplish this goalFunctional characterization of individual patient cancer cells provides insights that can be used to then guide treatment by determining the likelihood that a patient will respond to specific therapies that are dependent on these cell death signalsThis information can be used clinically to predict patient responseoutcomeor risk for certain adverse eventsThis strategy can be used to ensure appropriate stratification of patients into biologically relevant subcategories to enable more patient specific treatment selection