Aldevron — Department of Defense STTR Phase II: A12a-T028

Description

In this Phase II STTR proposal we will demonstrate the scalability and ruggedness of the production system necessary for the commercialization of the goose egg-derived immunoglobulin product that is a countermeasure to the lethal (40 %) Hantavirus Pulmonary Syndrome caused by Andes Virus (ANDV). A major objective will be creating a Quality System (QS) around the global process that aligns it with standards commensurate with FDA guidance. Related objectives will be the development of critical assays and the harmonization of the related Standard Operating Procedures into the QS. Pharmacokinetic and repeat dose studies will be performed that will allow us to better evaluate the quantities to be used and routes of delivery for the anti-ANDV product in the challenge study. Endpoints as measures of success would be the reproducible production of 5 g lots of low impurity anti-ANDV and the use of such lots affording clinically significant protection up to five days after challenge. These results would indicate the commercial viability of a platform that is based on the use of genetic immunization in geese as a means of creating therapies for Category-A pathogens for which no countermeasures or vaccines exist.