Sanofi, WRAIR Sign Research Pact For Zika Vaccine
Sanofi has formed a research agreement with the Walter Reed Army Institute of Research (WRAIR), a government biomedical research laboratory under the US Department of Defense, for the joint development of a Zika vaccine candidate. The Silver Springs, Maryland-based WRAIR will transfer its vaccine technology for Zika purified inactivated virus (ZPIV) to Sanofi Pasteur, the global vaccines business unit of Sanofi.
The agreement also includes clinical trial material produced by Sanofi Pasteur to support Phase II testing and characterization of vaccine product. The collaboration will also optimize the upstream process to improve production yields.
Sanofi Pasteur will create a clinical development and regulatory strategy while WRAIR will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV. WRAIR will also share biologic samples generated during non-human primate studies and biologic samples generated from human safety and immunogenicity studies using ZPIV.
WRAIR is coordinating pre-clinical development of the vaccine candidate based on new pre-clinical research it has conducted with Boston, Massachusetts-based Beth Israel Deaconess Medical Center as well as with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
NIAID will sponsor a series of Phase I ZPIV trials while the technology transfer process is occurring. NIAID is part of the US National Institutes of Health. Meanwhile, BARDA is a part of the Health & Human Services Office of the Assistant Secretary of Preparedness and Response.
While simultaneously working on the WRAIR technology, Sanofi Pasteur has been performing pre-clinical studies, utilizing a technology that was previously and successfully developed for vaccines used against dengue fever and Japanese encephalitis. The company has said that Zika, Japanese encephalitis, and dengue belong in the same family of viruses, known as Flavivirus, which are transmitted by the same type of mosquito. They share some similarities at the genetic level, and the company already has licensed vaccines against the latter viruses.
Sanofi Pasteur has been exploring partnerships with external experts to rapidly advance a Zika vaccine candidate because the pathway to developing a Zika vaccine candidate will take longer than of the previous Flavavirus vaccines they have already licensed.