AKSTON BIOSCIENCES CORPORATION — Department of Health and Human Services SBIR Phase II: 200

Description

PUBLIC DESCRIPTION Akston is developing a subcutaneously administered therapeutic for preventing or delaying the onset of diabetes in pre diabetic patients who are at high riskthose who display autoantibodies for insulinGADIAand ZnTfor developing TypediabetesT DThe therapeutic is designed to delete a subset of B cells that likely play a role in disease development using a patient s own antibody directed cell cytotoxicity machineryThe work covered in this submission builds on PhaseSBIR results obtained from mouse models of T DBefore entering into the IND stagehoweverAkston seeks to develop a clinically acceptable manufacturing processevaluate safety in rodent and non human primatesand confirm the therapeutic performance with human cells obtained from T D patientsDoing so will provide a critical risk reduction to justify further IND enabling safety and efficacy workandeventuallyclinical testing of the therapeutic in manThe impacts to public health as a result of this project are potentially significantHealthcare costs directly attributable to T D patients currently account for nearly $billion annuallyIn addition to themillion Americans who currently live with T Dnew T D patients are diagnosed each yearwith the rate of newly diagnosed patients ltyears of age increasing byin just the past decadeIf successfulAkston s therapeutic could lead to a significant reduction in health care costs and possibly free pre T D children and teenagers from a lifetime of glucose monitoring and insulin injections