Sanofi Pasteur said today its partnership with the Walter Reed Army Institute of Research (WRAIR) to carry out R&D of a Zika virus vaccine has been broadened to include the Oswaldo Cruz Foundation, through an expanded collaboration whose value was not disclosed.
The collaboration builds on one launched over the summer by Sanofi’s vaccines unit and WRAIR, in which the partners agreed to carry out R&D of a Zika vaccine using the Institute’s inactivated-virus vaccine (Zika purified inactivated virus, ZPIV) technology.
The Foundation is partnering through its Immuno-biological Technology Institute known as Bio-Manguinhos/Fiocruz with Sanofi Pasteur and WRAIR. Sanofi said Fiocruz’ activities will complement those of the company and Institute, deliver additional expertise, and increase the likelihood of successfully developing and licensing a safe and effective Zika vaccine as quickly as possible.
Areas of collaboration with Fiocruz could include process development, vaccine characterization, epidemiological studies, preclinical and clinical evaluation, and clinical assay optimization, Sanofi said.
“It only makes sense for the pursuit of public health that we combine our expertise and resources on Zika with Fiocruz, which is ideally based in Brazil where the heart of the current Zika experience lies,” John Shiver, Ph.D., svp for R&D at Sanofi Pasteur, said in a statement.
WRAIR is providing its ZPIV candidate to Sanofi Pasteur to produce clinical material in compliance with current GMP to support Phase II testing, optimize the upstream process to improve production yields, and characterize the vaccine product. WRAIR and the U.S. National Institute for Allergy and Infectious Diseases (NIAID) have agreed to sponsor and support a series of Phase I trials.
Last month, Sanofi disclosed that the Biomedical Advanced Research and Development Authority (BARDA) agreed to award $43.2 million toward Sanofi Pasteur’s manufacture of the inactivated Zika vaccine for Phase II development.
Sanofi Pasteur is working to create a clinical development and regulatory strategy while WRAIR and NIAID are conducting the Phase I ZPIV trials. The BARDA contract includes an option allowing the agency to continue supporting the R&D work through Phase III industrial and clinical development, Sanofi added.