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 U.S. Food and Drug Administration (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 utilized its proprietary VelociGene® and VelocImmune® technologies, which enable the rapid 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 enabled the rapid identification and scale-up of the investigational antibody therapy. To date, Regeneron has conducted pre-clinical 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.
"We're proud to work with BARDA to apply our unique rapid response capabilities to Ebola, one of the most critical global health crises of recent times," said Neil Stahl, Ph.D., Executive Vice President of Research and Development at Regeneron. "Regeneron's mission is to use science and technology to transform outcomes for people living with serious diseases. In the midst of an emerging outbreak, every day counts for people who are infected or at risk. Regeneron's technologies create manufacturing-ready cell lines of validated fully human antibodies in just months, offering the distinct promise of better treatments in shorter timeframes."
In addition to Ebola, Regeneron's proprietary antibody rapid response platform has been used to generate antibodies for Middle East Respiratory Syndrome (MERS) and has the potential to address other emerging infectious diseases.