Protecting Newborns from RSV by Immunizing Moms-to-Be
International nonprofit organization PATH has provided Novavax with some $2 million in initial funding as part of a clinical development partnership focused on Novavax’ respiratory syncytial virus (RSV) vaccine candidate designed to protect newborns from RSV infection through immunization of pregnant women. The initial funds will support a Phase II study evaluating the immune response to different doses of the vaccine in women of childbearing age. With additional PATH funding the partners may then advance clinical development of a recombinant RSV fusion F protein vaccine that is administered to pregnant women to trigger the production of protective antibodies that are transferred to their offspring in utero.
Under terms of the partnership PATH could fund up to 50% of Novavax’ external clinical development costs. The firm will retain global rights to commercialize the vaccine, and has made a commitment to make it affordable and available in low-resource countries.
Maternal immunization is widely used for protecting infants against diseases such as neonatal tetanus. However, there is currently no approved RSV prophylactic vaccine available, and Novavax estimates the global market for such a product could exceed $5 billion.
“This partnership with PATH complements our corporate strategy to develop this RSV vaccine for multiple indications in affected patient populations, in all markets throughout the world with multiple partners,” remarks Stanley C. Erck, president and CEO of Novavax. “This partnship further validates the promise of our recombinant nanoparticle vaccines.”
Novavax is leveraging its virus-like particle (VLP) and recombinant nanoparticle technologies, and manufacturing platform, to develop vaccines against a broad range of infectious diseases. Its clinical pipeline is headed by VLP-based seasonal and pandemic influenza vaccines, which are in Phase II development.
The agreement with PATH follows just two days after Novavax announced a collaboration with CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a VLP-based malaria vaccine in India.