Paris-based Sanofi and its vaccines global business unit Sanofi Pasteur have announced a cooperative 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.
The agreement also includes Sanofi Pasteur’s production of clinical material to support phase 2 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 immunological assays designed to measure neutralizing antibody responses after natural infection and vaccination with ZPIV; biological samples generated during the performance of non-human primate studies; and biological samples generated during the performance of human safety and immunogenicity studies using ZPIV.
The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor a series of phase 1 trials of ZPIV while the technology transfer process is under way.
John Shiver, PhD, senior vice president for research and development at Sanofi Pasteur, reported that while simultaneously working on the WRAIR technology, Sanofi is performing preclinical studies, using a technology previously 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, Shiver continued, that pathway will take longer to get a Zika vaccine candidate into the clinic, so Sanofi Pasteur has been exploring partnerships with external experts to rapidly advance a vaccine candidate.
Sanofi is the only major drug-maker working on a vaccine against the Zika virus, which has been linked to birth defects and neurological disorders, although more than a dozen smaller biotech firms and other groups are also active in the field, according to a Reuters press release.
The WRAIR vaccine is one of the furthest advanced in development and could be ready for testing in human subjects in October. In a study published in Nature last week, a single dose of the vaccine was shown to confer 100% protection in mice against the Zika virus.
Source: Sanofi; July 6, 2016.
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