EVORX TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTIONprovided by applicantHeris expressed inof breast cancers and correlates with highly aggressive diseaseHertargeted therapies are highly efficacious against Herpositive canceryet no clinical imaging agents can assess Herstatus in vivoEvoRx Technologies has developed a method to discover cyclic peptides that have antibody like affinities and selectivitieshigh stability in serumand rapid systemic clearanceIn our Phase I contractwe showed that EVOhas rapidhigh levels of tumor uptake with minimal background in mouse modelsdeveloped an efficientautomated radiochemical synthesisand obtained preliminary PET CT images in mice showing specific tumor uptake as well as rapid clearance and low liver uptakeIn Phase IIwe aim to complete pre clinical experimentsenabling first in human PET CT imaging studies with EVOWe will use mouse model imaging studies of primary and metastatic cancer models to establish the sensitivity and limit of detection for Herpositive diseaseoptimize EVOradiochemical synthesis for clinical productionperform GMP validation studiesand establish dosimetry in rodent and primate models to determine tracer toxicity and establish the maximum safe dose for patient trialsLastlywe will obtain an IND to deploy our PET tracer in patients with Herpositive inflammatory breast cancer to demonstrate safety and concordance with biopsy proven Herpositive disease