Sanofi said today it is partnering with the Walter Reed Army Institute of Research (WRAIR) to co-develop a Zika vaccine candidate through a collaboration whose value was not disclosed.
According to terms of a Cooperative Research and Development Agreement between the partners, WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to the pharma giant’s Sanofi Pasteur vaccine unit.
“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,” said David Loew, evp, head of Sanofi Pasteur. “This exciting collaboration with the WRAIR creates the opportunity to rapidly move forward.”
Sanofi Pasteur has agreed to produce GMP-compliant clinical material to support Phase II testing, as well as 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, added Sanofi, which is among more than a dozen vaccine developers scrambling to produce a Zika vaccine.
In return, WRAIR has agreed to 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 nonhuman primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV.
WRAIR, the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA) have been coordinating preclinical development of the vaccine candidate.
That work has been encouraged by new preclinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center. In a study published last week in Nature, a single dose of the WRAIR vaccine “afforded complete protection against [Zika] as measured by absence of detectable viremia following challenge,” corresponding author Dan H. Barouch, M.D., Ph.D., of Beth Israel Deaconess and Harvard Medical School and investigators concluded.
“Our findings suggest that the development of a [Zika] vaccine for humans will likely be readily achievable,” Dr. Barouch and investigators added.
NIAID will sponsor a series of Phase I ZPIV trials while the technology transfer process is occurring, Sanofi Pasteur said. A Phase I trial will start in October, Col. Nelson Michael, co-lead of WRAIR’s Zika program, told The Wall Street Journal.
While simultaneously working on the WRAIR technology, Sanofi Pasteur is performing preclinical studies using a technology previously and successfully developed for both its dengue fever and Japanese encephalitis vaccines. Because that pathway will take longer to get a Zika vaccine candidate into the clinic, Sanofi Pasteur has been exploring partnerships with external experts to advance a vaccine candidate rapidly, said John Shiver, Ph.D., the company’s svp for R&D.“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,” Dr. Shiver added.