GAITHERSBURG, Md.—Novavax Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced recently that it will utilize the accelerated approval pathway for licensure for NanoFlu, its nanoparticle seasonal influenza vaccine candidate. The U.S. Food and Drug Administration (FDA) acknowledged in a recent letter that the accelerated approval pathway is available to Novavax for its NanoFlu vaccine.
Furthermore, Novavax expects to initiate its pivotal Phase 3 clinical trial by the fall of 2019, with top-line clinical data expected in the first quarter of 2020. These immunogenicity data are expected to support a U.S. biologics license application (BLA).
Novavax will conduct an end-of-Phase 2 meeting with the FDA in the third quarter of 2019 to discuss the proposed Phase 3 clinical trial design and other topics that will support the future BLA. The accelerated approval pathway enables Novavax to conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.
“NanoFlu’s encouraging results observed in prior clinical trials, which demonstrated improved immune responses against licensed comparators, provide us confidence in the future success of the Phase 3 clinical trial,” said Dr. Gregory M. Glenn, president of research and development of Novavax. “The accelerated approval pathway allows us to potentially obtain U.S. licensure more expeditiously, and ideally, deliver a greatly needed improved flu vaccine, which could reduce the tremendous medical and economic burden of influenza.”
“The accelerated approval pathway, combined with the strategic partnership we announced ... with Catalent Biologics, allow us to efficiently and cost-effectively complete the clinical development of NanoFlu through BLA and licensure,” added Stanley C. Erck, president and CEO of Novavax. “The Catalent deal provides an $18-million cash infusion and flexible manufacturing capacity, supported by the experienced professionals transferred from Novavax to Catalent.”
Earlier this year, Novavax released positive top-line results of its Phase 2 clinical trial of NanoFlu in older adults. The data showed NanoFlu induced improved immune responses when compared to the best-selling flu vaccine in the older adult market. The Phase 2 clinical trial compared the safety and immunogenicity of various quadrivalent formulations of NanoFlu with or without the Matrix-M adjuvant with two licensed influenza vaccines in 1,375 healthy older adults. All formulations of NanoFlu were well tolerated and elicited vigorous immune responses to the four strains included in the vaccine. NanoFlu also demonstrated significantly improved hemagglutinin inhibition antibody responses against wild-type H3N2 viruses, including drifted strains when compared to Fluzone High-Dose, the leading flu vaccine in older adults.
