Novavax’ preclinical influenza nanoparticle study published in Vaccine

Data suggest that NanoFlu has the potential to elicit a broader, more robust immune response, resulting in greater protection than the market-leading licensed influenza vaccine in older adults.

The manuscript describes the formulation of Novavax’ novel seasonal influenza vaccine candidate, NanoFlu, based on the 2017-2018 World Health Organization (WHO) recommended influenza strains. The study, conducted in ferrets, found that NanoFlu induced hemagglutination-inhibition (HAI) and microneutralizing (MN) antibodies against a broad range of influenza subtypes. In a head-to-head comparison against standard-dose and high-dose (HD) inactivated influenza vaccines in ferrets, NanoFlu elicited higher HAI and MN antibody responses exceeding those induced by the high-dose vaccine against recent (homologous) A(H3N2) by 7-fold, A(H1N1) by 26-fold, and B strain viruses by 2-fold. Additionally, NanoFlu induced superior protection in a ferret challenge model against a homologous and a 10-year old drifted influenza strain spanning over a decade.

“These data suggest that NanoFlu has the potential to elicit a broader, more robust immune response, resulting in greater protection than the market-leading licensed influenza vaccine in older adults, Sanofi’s Fluzone High-Dose. NanoFlu outperformed standard dose Fluzone and Fluzone HD in HAI assays, an established surrogate marker of protection,” said Gregory Glenn, President, Research and Development. “Further, these data suggest NanoFlu has the potential to address the problem of annual strain mismatch due to its ability to induce highly neutralizing antibodies against a broad range of influenza strains. These data show that NanoFlu provides improved protective responses to both the current recommended influenza strains as well as drifted strains.”

“Novavax has over a decade of experience in developing both seasonal and pandemic influenza vaccine candidates. Based on the superior attributes of our nanoparticle based vaccine candidates, we transitioned our influenza development activities to our nanoparticle vaccine platform,” said Stanley C. Erck, President and CEO. “The data in this publication further validate our nanoparticle vaccine platform and provide a strong rationale for advancing NanoFlu into a Phase I/II clinical trial. Our goal is to deliver a superior, differentiated vaccine to the greater than $3 billion global seasonal influenza commercial market.”