Nanovax’s seasonal flu vaccine meets Phase 3 endpoints and matches Sanofi’s Fluzone
pharmafile | March 24, 2020 | News story | Manufacturing and Production, Research and Development | NanoFlu, Nanovax, influenza, pharma
Nanovax has reported positive Phase 3 data for its vaccine NanoFlu, with the candidate meeting its primary endpoints in the prevention of influenza.
The study compared Nanovax’s “recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant” to Sanofi Pasteur’s US-approved Fluzone Quadrivalent vaccine candidate in adult patients of at least 65 years old.
Throughout the trial, the vaccine showed non-inferior immunogenicity to Sanofi’s candidate as measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. In all four flu strains, NanoFlu met its primary endpoints using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR).
“In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents,” commented Dr Gregory Glenn, President of Research and Development of Novavax. “NanoFlu demonstrated significant improvement against four drifted H3N2 strains that are co-circulating this year. These data, similar to what was shown in our Phase 2 clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift.”
The candidate was also found to have a comparable safety profile to Fluzone Quadrivalent, with a “modest increase” in adverse events experienced by patients.
“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” remarked Stanley C Erck, President and Chief Executive Officer of Novavax. “These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”
Matt Fellows
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