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.
About Regeneron Pharmaceuticals, Inc.
Regeneron (REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for nearly 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and more than a dozen product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, and infectious and rare diseases. Regeneron is accelerating and improving the traditional drug development process through its unique VelociSuite® technologies, including VelociGene® and VelocImmune®, and ambitious initiatives such as The Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.