The agreement also includes Sanofi Pasteur's production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product. Sanofi Pasteur will also create a clinical development and regulatory strategy.
WRAIR will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV, biologic samples generated during the performance of non-human primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV. WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID) - part of the U.S. National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) - part of the Health & Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response - have been coordinating pre-clinical development of the candidate encouraged by new, pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center. NIAID will sponsor a series of phase 1 ZPIV trials while the technology transfer process is occurring.
"In addition to exploring our own vaccine technology used in our new dengue fever vaccine, we are looking at other pathways to get a Zika vaccine into the clinic as soon as possible. Therefore, this exciting collaboration with the WRAIR creates the opportunity to rapidly move forward," said David Loew, Executive Vice President, Head of Sanofi Pasteur.
John Shiver, PhD, Sr. VP for R&D at Sanofi Pasteur, explained that while simultaneously working on the WRAIR technology, Sanofi Pasteur is performing pre-clinical studies, utilizing a technology previously and successfully developed for both its dengue fever and Japanese encephalitis vaccines. "Zika, Japanese encephalitis, and dengue belong to the same family of viruses (Flavivirus), are transmitted by the same type of mosquito, and share some similarities at the genetic level, and we already licensed vaccines against those flaviviruses."
However, he continued, since that pathway will take longer to get a Zika vaccine candidate into the clinic, Sanofi Pasteur has been exploring partnerships with external experts to rapidly advance a vaccine candidate. "We're looking at this from both a short- and long-term perspective, collaborating to get into the clinic quicker to provide a vaccine in response to the current emergency, and adapting our own technology to ensure production capacity of a vaccine for years to come."
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development.