NanoFlu Influenza Vaccine Phase 3 Study Launches
Novavax NanoFlu is a Matrix-M adjuvanted recombinant nanoparticle vaccine eliciting antibodies that neutralize circulating flu viruses and the newly evolved H3N2 viruses
A Maryland based biotechnology company announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged 65 and over.
The late-stage trial, for which the 1st participants have been enrolled, will evaluate the immunogenicity and safety of NanoFlu with its proprietary Matrix-M™ adjuvant, compared to a U.S.-licensed quadrivalent influenza vaccine.
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences.
Stanley C. Erck, President and Chief Executive Officer of Novavax, said in a press release, “With current vaccine efficacy at 12 percent in older adults, NanoFlu may address a major unmet need.”
The phase 3 trial will enroll approximately 2,650 healthy older adults across 19 U.S. clinical sites. Top-line clinical data from the randomized, observer-blinded, active-controlled trial is expected in the first quarter of 2020.
Previously, positive top-line results of the Phase 2 clinical trial of NanoFlu in older adults released in January 2019 showed that NanoFlu induced improved immune responses when compared to the best-selling flu vaccine in the older adult market.
Gregory Glenn, M.D., President of Research and Development of Novavax, added, “We have shown that NanoFlu, a Matrix-M adjuvanted recombinant nanoparticle, elicits antibodies that neutralize the predicted circulating viruses, historic circulating viruses, and the newly evolved H3N2 viruses.”
“In addition, the induction of robust flu specific effector T cells in older adults further distinguishes NanoFlu from licensed comparators.”
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children, and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans.
An estimated one million deaths globally each year are attributed to influenza, said the company.
Novavax, Inc. (NASDAQ: NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. For more information, visit Novavax.
Influenza vaccines news published by Precision Vaccinations