Novavax’s RSV jab protects infants in PhII, nets $89M Gates Foundation grant

This grant will also support regulatory licensing efforts, providing a path to World Health Organization prequalification.

The trial was a randomized, observer-blinded, Phase 1 study to evaluate the safety and immunogenicity of the RSV F Vaccine, with one or two doses, with or without aluminum phosphate adjuvant, in healthy pediatric participants two to six years of age.

The Bill & Melinda Gates Foundation has awarded a grant of about $89m to Novavax for supporting development of the RSV F Vaccine Phase 3 clinical trial in pregnant women.

Biotechnology firm Novavax Inc said records typically from center-point in time study found that immunizing women who are pregnant because of its RSV vaccine worked in securing infants beginning with the viral infection.

Novavax will take RSV F into Phase III in early 2016, the company said. “It should not be lost on those interested in Novavax that this announcement is the fifth positive clinical trial readout provided during the third quarter of this year, a pivotal achievement for the Company made possible by the power of our recombinant nanoparticle platform technology and this dedicated and experienced team”.

Now, with $89 million in new funding, Novavax is moving the RSV vaccine into phase 3. MedImmune’s monoclonal antibody Synagis(palivizumab)-which gained initial USA approval in 1998-targets the RSV F protein and is indicated for prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. They were followed through the remainder of their pregnancies, delivery and for an additional 180 days postpartum to assess safety and immunogenicity as measured by serum RSV anti-F IgG, microneutralising, and palivizumab-competing antibody (PCA) titers. There are no approved RSV vaccines now available. Women who received the placebo showed no significant change in their antibody levels. The estimated half-lives of infant PCA, anti-F IgG, RSV/A and RSV/B microneutralizing antibodies, based on data through day 60, were 41, 30, 36 and 34 days, respectively. In the trial, the company reported that the vaccine was safe, transferred effectively from mother to infant, and generated a significant antibody response.

“Our groundbreaking Phase II results in both maternal and older adult target populations, underscore the promise of our RSV F Vaccine programs”, Novavax President and CEO Stanley C. Erck stated.