Regeneron Pharmaceuticals has announced two new collaborations with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to develop new treatments combating infectious diseases. The first collaboration is focused on discovery, research, development and manufacturing of a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health, starting with Influenza virus. The second collaboration (announced by HHS on September 29) builds on a prior agreement to develop and manufacture Regeneron's potential therapy for Ebola virus. This investigational treatment has completed a Phase 1 clinical study and received Orphan Drug Designation from the U.S. Food and Drug Administration.
Both drug development efforts utilize Regeneron's proprietary VelociSuite® technologies that facilitate rapid identification, preclinical validation and development of suitable antibody candidates.
"We look forward to expanding upon our prior work with BARDA, as we continue our joint efforts to address serious public health threats," said George Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Our decades of investment in foundational technology platforms have resulted in a cutting-edge approach to drug discovery and development, and we're proud to apply this technology against serious infectious threats such as Influenza virus and Ebola virus."
The emerging pathogens treatment portfolio will be pursued using an Other Transaction Agreement (OTA), which provides a funding and collaboration vehicle for HHS to promote innovation in technology for advanced research and development. Under the OTA, which has a term of 10 years, HHS will fund 80 percent of Regeneron's costs for research, development and manufacturing activities for antibodies that are selected to move forward. Up to 10 target pathogens may be jointly selected by BARDA and Regeneron. The first selected program will target Influenza virus and receive initial funding of more than $18 million for early-stage antibody discovery, development and manufacturing.
"Influenza and other emerging infectious diseases present serious threats to our nation's health security," said Rick Bright, Ph.D., BARDA Director. "This partnership will support much-needed treatment options for those who are severely ill with influenza and the rapid drug development that is critical to save lives when a new disease emerges."
"Regeneron's unique rapid response platform enables us to move from preclinical research to clinical development in a matter of months instead of years," said Neil Stahl, Ph.D., Executive Vice President of Research and Development at Regeneron. "We can apply our technologies swiftly against known and currently unknown infectious agents, giving us the dexterity to potentially help as many people as possible should a public health emergency arise."
Under the separate Ebola agreement, HHS will provide approximately $40 million in initial committed funding for continued development of REGN3470-3471-3479, a single therapy that contains three monoclonal antibodies. Subsequent phases of funding may support clinical investigation, a potential Biologics Licensing Application (BLA) and initial procurement of the therapy for the Strategic National Stockpile. BARDA and Regeneron announced in September 2015 an agreement to support development of this antibody therapy through its first Phase 1 trial.
Regeneron and BARDA also have an existing agreement to develop a treatment for Middle East Respiratory Syndrome (MERS). Regeneron has identified and validated Spike-protein blocking antibodies, and an NIH-sponsored Phase 1 clinical trial in adult patients is expected to be initiated by the end of the year.