Regeneron Pharmaceuticals signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services to develop, test, and manufacture a monoclonal antibody therapy for the treatment of Ebola virus infection. HHS will provide initial funding of approximately $17 million to support preclinical development and antibody manufacturing.
This initial funding is designed to support an Investigational New Drug application with the FDA. Options in the agreement provide for an additional $21 million for a Phase 1 study in healthy volunteers, which is planned for January 2016, and further manufacturing and development studies.
Regeneron used its proprietary VelociGene® and VelocImmune® technologies, which reportedly enable the identification and preclinical validation of fully human monoclonal antibodies, to develop a novel antibody therapy “cocktail” which includes a mixture of three antibodies. These technologies reportedly enable the identification and scaleup of the investigational antibody therapy. To date, Regeneron has conducted preclinical studies in animal models of Ebola virus infection. These antibodies have been discovered and developed pursuant to Regeneron's 2009 antibody discovery and development agreement with Sanofi and are subject to Sanofi's opt-in rights for development and commercialization.
Regeneron's proprietary antibody response platform also has been used to generate antibodies for Middle East Respiratory Syndrome (MERS) and has the potential to address other emerging infectious diseases, according to Regeneron officials.