Sanofi and its vaccines global business unit, Sanofi Pasteur, have announced a co-operative research and development agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. According to the terms of the agreement, WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to Sanofi Pasteur, opening the door for a broader collaboration with the US government.
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 US 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 co-ordinating preclinical development of the candidate encouraged by new, preclinical 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 preclinical 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,” he said.
However, he continued, as 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.”