BARDA, an agency of the U.S. Department of Health and Human Services (HHS), agreed to provide the funding to support packaging and labeling of the antibodies for human use, the preparation and submission of an IND application with the FDA, and a National Institutes of Health (NIH)-conducted clinical trial in healthy volunteers.
Last year, Regeneron researchers published a paper in Proceedings of the National Academy of Sciences (PNAS) disclosing how its proprietary VelociGene® and VelocImmune® technologies enabled rapid identification and preclinical validation of the MERS antibody candidates.
The MERS antibodies are subject to Sanofi opt-in rights for development and commercialization, having been discovered and developed pursuant to Regeneron's antibody discovery and preclinical development agreement with the pharma giant.
There are no medicines or vaccines approved by the FDA to treat or prevent MERS.
Regeneron and BARDA agreed in September 2015 to advance a potential Ebola therapy discovered and developed at Regeneron using VelociGene and VelocImmune, with HHS agreeing to provide initial funding of approximately $17 million to support preclinical development and antibody manufacturing.
The investigational Ebola therapeutic recently entered a Phase I human clinical study, Regeneron said, and has received the FDA’s Orphan Drug Designation.
“In addition to the programs in MERS and Ebola that we are advancing with BARDA, we are also quickly progressing a preclinical program targeting the Zika virus,” Neil Stahl, Ph.D., Regeneron evp of R&D, said in a statement.