Sanofi Pasteur enters co-development agreement with WRAIR for Zika vaccine
Posted: 6 July 2016 | Victoria White, Digital Content Producer | No comments yet
Sanofi Pasteur has signed a Cooperative Research and Development Agreement with the 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.
Commenting on the agreement, David Loew, Executive Vice President, Head of Sanofi Pasteur, said: “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.”
The agreement also includes Sanofi Pasteur’s production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support Phase II testing, optimisation of the upstream process to improve production yields, and characterisation 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 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. WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA) have been coordinating preclinical development of the candidate encouraged by new, preclinical 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.
Sanofi Pasteur utilises technology successfully developed for dengue vaccines
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, utilising 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.”