"In March 2020, we announced positive top-line results from our Phase 3 clinical trial of our nanoparticle seasonal quadrivalent influenza vaccine candidate, including our proprietary Matrix-M™ adjuvant (NanoFlu™). The trial was a randomized, observer-blinded, active-controlled trial in approximately 2,652 healthy older adults (aged 65 years and older) across 19 clinical sites in the United States. The trial evaluated the immunogenicity and safety of NanoFlu™ compared to a US-licensed quadrivalent vaccine, Fluzone® Quadrivalent. The trial’s primary objective was to demonstrate noninferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous seasonal influenza strains compared to a licensed seasonal vaccine and to describe its safety profile.
NanoFlu achieved all the primary endpoints, was well tolerated, and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events. NanoFlu also achieved statistical significance in key secondary endpoints. This positive data will support a US biologics license application (BLA), which will include process performance qualification (PPQ), a lot consistency clinical trial, and licensure of NanoFlu using the US Food and Drug Administration’s (FDA) accelerated approval pathway."