TARRYTOWN, N.Y.—In pursuit of new options for Middle East respiratory syndrome (MERS), Regeneron Pharmaceuticals Inc. has begun an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) to study and manufacture a pair of antibody therapies for this indication.
Per the terms of the agreement, Regeneron will receive up to $8.9 million from HHS to support packaging and labeling of the antibodies for human use, the preparation and submission of an Investigational New Drug application with the U.S. Food and Drug Administration and a clinical trial in healthy volunteers conducted by the National Institutes of Health.
"Regeneron has built a unique rapid response platform to address emerging infectious disease threats. 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," Dr. Neil Stahl, executive vice president of Research and Development at Regeneron, said in a press release. "We are committed to partnering with the government and other organizations to swiftly address these emerging public health emergencies."
Regeneron notes that its proprietary VelociGene and VelocImmune technologies “enable the rapid identification and preclinical validation of fully human monoclonal antibodies.”
MERS was first reported in Saudi Arabia in 2012, according to the U.S. Centers for Disease Control (CDC), and since then cases have been reported throughout the Middle East as well as in South Korea, the United States, Africa and other countries in Asia. It is caused by a coronavirus known as Middle East Respiratory Syndrome Coronavirus (MERS-CoV), and those infected face severe acute respiratory illness, with symptoms that include fever, cough and shortness of breath. The CDC reports that 3 to 4 of every 10 patients stricken with MERS have died, and at present, there are no options for prevention or treatment of MERS.
This is not the first time Regeneron has teamed up with BARDA; in September 2015, the company announced an agreement with BARDA to develop, test and manufacture a monoclonal antibody therapy for Ebola. It was slated to begin Phase 1 studies in January 2016, and the U.S. Food and Drug Administration has granted it Orphan Drug Designation.
The MERS antibodies in question were discovered and developed pursuant to Regeneron's antibody discovery and preclinical development agreement with Sanofi, and as such are subject to the latter's opt-in rights for development and commercialization.
Regeneron and Sanofi have collaborated since 2007 on the discovery, development, manufacture and commercialization of fully human monoclonal antibodies using Regeneron's VelociSuite technologies. They expanded the collaboration in 2009 with the aim of moving 20 to 30 antibodies into clinical development by 2017. Last July, they announced a global collaboration for the discovery, development and commercialization of antibody cancer treatments in immuno-oncology.