Agilvax, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Agilvax s AXis an Immunotherapy for Triple Negative Breast CancerAgilvax is developing cancer immunotherapies and vaccines with its proprietary virus like particleVLPplatform technologyAgilvax s lead productAXis an immunotherapy for triple negative breast cancerTNBCtargeting cancer stem cellsCSCthat is designed for use in combination with existing and emerging therapiesTNBC is extremely aggressive with high rates of recurrence and overall poor outcomes as compared to other forms of breast cancerThe averageyear survival rate for metastatic patients with TNBC is onlyTNBC is more likely to occur in women under the age ofand the rate of incidence is higher in African American and Hispanic populations as compared to Caucasian populationsIt is estimated thatwomen will be diagnosed with TNBC inAXTargets Breast Cancer Stem Cells to Prevent Relapse and MetastasisWith no CSC targeted therapies currently availablethere is a critical need for the development of therapeutics for patients impacted by TNBCAXis composed of a VLP that displays a specific portion of a proteinxCTthat is overexpressed in breast cancer stem cellsBCSCand contributes to chemotherapeutic drug resistance and metastasisAXis favorably positioned in the emerging market of various treatment approaches targeting TNBCwhich will increasingly segment the patient population by novel biomarkers and molecular targetsDue to their resistance to radiation and chemotherapiesBCSC represent a reservoir for the relapsemetastatic evolution and progression after initial treatmentAXproduces an oligoclonal antibody response against the BCSC targetxCTthat will eliminate BCSC as a source of recurrenceAgilvax s Aims for the Fast Track SBIR Include Preclinical WorkcGMP Manufacturing and a Toxicology StudyAgilvax s goals for this grant are to complete its preclinical workincluding upstream and downstream process development of AXbased on processes the company successfully used in developing another VLP based productAs part of its first goalAgilvax will strengthen AXefficacy by determining the optimal dosage regimenconfirming efficacy in a second tumor modeland assess the combination of AXwith other chemotherapeutic agents in planning for the Phase I trial designAgilvax will proceed with cGMP production and validation of research and master cell banks in order to complete cGMP manufacturing and release testing of AXdrug substance and drug productUpon the recommendation of Agilvax s Key Opinion Leaders in breast cancera single nonclinical toxicology study using New Zealand white rabbits is planned Breast cancer stem cellsBCSChave unique biological properties that represent a key cellular reservoir for relapsemetastatic progression and therapeutic resistanceAXis an immunotherapy candidate based on Agilvax s virus like particle technology that targets the BCSC protein xCTSLC Aand inhibits metastasesAgilvax s Aims for the Fast Track SBIR includedosage regimen optimizationcGMP manufacturing and a nonclinical toxicology study