DEVELOPMENT OF ENZYME-LINKED IMMUNOSORBENT ASSAYS (ELISAS) FOR NINDS NIH BLUEPRINT NEUROTHERAPEUTICS (BPN) BIOLOGICS PROJECT

Battelle Centers/Pub Hlth Res & Evaluatn, Columbus OH

Investigators

Abstract

The National Institute of Neurological Disorders and Stroke (NINDS), via its Blueprint (BPNBiologics) network, is funding a cooperative agreement for the development of an antibody for treatment of Duchenne’s muscular dystrophy (DMD). The goals of the BPN-Biologics cooperative agreement are to optimize the lead antibody, evaluate short-term in vivo efficacy of the optimized lead antibody(ies), complete pre-clinical studies and manufacturing, and progress the lead clinical candidate antibody(ies) through IND-enabling studies and an IND regulatory filing. A single down-selected lead progeny antibody with optimal characteristics will then progress to IND-enabling in vivo and in vitro studies and to clinical trial evaluation. The mission of the National Institute of Neurological Disorders and Stroke is to seek fundamental knowledge about the brain and nervous system, such as DMD, and to use that knowledge to reduce the burden of neurological disease for all people.