On Apr. 8, 2020, Novavax announced it had identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax proprietary nanoparticle technology, and planned to initiate a first-in-human trial in mid-May. Novavax proprietary Matrix-M adjuvant was incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.

The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 clinical trial is a placebo-controlled observer blinded study of ~130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety results in July.

As previously announced, in March, Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials. This agreement offers the potential to leverage Emergent’s rapid deployment capabilities and expertise that provide Novavax scalability and capacity to produce vaccine product. Also in March, the Coalition for Epidemic Preparedness Innovations (CEPI) awarded an initial funding of $4 million to support Novavax’ efforts, with additional funding discussions ongoing.

Novavax is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax recently initiated development of a vaccine program against COVID-19, with human results expected in July of 2020.