Novavax Initiates Phase 1/2 Trial of NanoFlu(TM) Vaccine in Older Adults

• Recently published NanoFlu(TM) preclinical data provide strong rationale for Phase 1/2 clinical trial based on robust antibody titers and improved protective responses against both current and drifted strains
  
• Data from trial expected by the end of 2017

GAITHERSBURG, Md., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults.

The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).

"The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD," said Gregory Glenn, M.D., President of Research and Development. "We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.

"Our recent preclinical data further indicate NanoFlu elicits improved protective responses against drifted strains, which could be a key differentiating factor of the vaccine. Current influenza vaccine protection is typically limited to strain-specific immune responses. Strain mismatch or antigenic drift between seasonal vaccines and circulating influenza strains can lead to reduced protection."

"The data described in our recent Vaccine publication provided strong rationale for advancing our NanoFlu program into the clinic," said Stanley C. Erck, President and CEO. "Seasonal influenza remains a significant threat to older adults, with nearly three million infections and over 250,000 hospitalizations annually¹. Our goal is to deliver a differentiated flu vaccine to the greater than $3 billion global seasonal influenza commercial market² and we look forward to delivering clinical data from this trial by the end of the year."