The Walter Reed Army Institute of Research will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to French drugmaker
Sanofi is to co-develop a Zika vaccine candidate with the US-based Walter Reed Army Institute of Research (WRAIR).
The partners have signed a Cooperative Research and Development Agreement under which WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to the French drugmaker's vaccines business unit Sanofi Pasteur, forming a broader collaboration with the US government.
Sanofi Pasteur will also produce clinical material in compliance with current GMP (Good Manufacturing Practices) to support Phase II testing, optimise the upstream process to improve production yields, and characterise the vaccine product.
In addition, the firm will create a clinical development and regulatory strategy.
WRAIR will share data related to the development of immunologic assays designed to measure neutralising 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.
We are looking at other pathways to get a Zika vaccine into the clinic as soon as possible
WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), which is 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 Centre. NIAID will sponsor a series of Phase I 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.
While simultaneously working on the WRAIR technology, Sanofi Pasteur is performing pre-clinical studies, using a technology previously and successfully developed for its dengue fever and Japanese encephalitis vaccines, which belong to the same family of viruses as Zika.
But as that pathway will take longer to get a Zika vaccine candidate into the clinic, the firm 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,' said John Shiver, Senior VP for R&D at Sanofi Pasteur.