PRESAGE BIOSCIENCES, INC. — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTIONprovided by applicantImprovements in cancer diagnostics and therapeutics have positively impacted outcomes for oncology patients within select clinical nichesHoweversignificant therapeutic uncertainty awaits the majority of today s oncology patients who present in the clinic with cancer that will relapse after exhibiting an initial response or whose cancer is already refractory to standard of careSOCtherapyUnfortunatelythe absence of technology that accurately predicts a patient s non response to SOC means many patients will experience toxic side effects to systemic therapy without receiving clinical benefitSuch patients will also lose valuable time and money that could be used to identify and finance more effective treatments andin some cases under the selective pressure induced by suboptimal therapywill develop pan resistance rendering alternate treatments ineffectiveSuccessful translation of Presage s innovative CIVO technology into the oncology clinic will provide a personalized system that identifies patients whose cancer is not going to respond to SOCthereby limiting unwarranted exposure to costlyineffective therapy and its associated toxicity while increasing time available for evaluation of new therapeutic modalities at earlier stages of diseaseSpecificallyCIVO is a hand held microinjection device engineered to deliver minute amounts of up to eight drugs or drug combinations directly into a patient s solid tumorCIVO is complemented by an automated analytical package that measures tumor cell specific and microenvironment alterations at the single cell levelrevealing comprehensive profiles of an individual s tumor response to each injected agentFurthermoreCIVO is superior to alternative platforms developed to predict tumor response to chemotherapy due to CIVO s enablement of evaluating drug response in vivoin the patients living tumorin the natural context of native tumor stroma and the host immune systemThe CIVO clinical trial detailed in this application is designed to establish the negative predictive valueNPVof CIVO in diffuse large B cell lymphomaDLBCLpatients who are candidates for one of three second line SOC therapiesThe initial training stage of the trial will be a nonblindedretrospective study used to establih CIVO quantitative thresholds for determining if a patient s lymphoma is "non responsive" to microinjected drug in relation to the patient s response to systemic therapyThe second stageor "Test" phaseof the trial will employ the quantitative threshold sobtained from the training stage to determine if CIVO can predict non response to systemic second line therapySBIR support in establishing CIVO clinical NPV in DLBCL will build the clinical foundation required to expand translation of CIVO into additional tumor typesserving to drive more efficient and cost effective patient segregation and therapeutic selection in the oncology clinic