Novavax sets first-in-human trial for coronavirus vaccine candidate in mid-May


Novavax (NASDAQ:NVAX) identified a coronavirus vaccine candidate, NVX-CoV2373, using its nanoparticle technology, and will initiate a first-in-human trial in mid-May.

Novavax’s Matrix-M adjuvant will be 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 about 130 healthy adults and includes assessment of dosage amount and number of vaccinations. Preliminary immunogenicity and safety results are expected in July.

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. Also, in March, the Coalition for Epidemic Preparedness Innovations awarded Novavax $4-million to support its efforts, with additional funding discussions ongoing.

“This progress demonstrates the ability of our recombinant nanoparticle technology to rapidly create vaccine candidates for emerging viruses like SARS-CoV-2,” Stanley Erck, president and CEO of Novavax, said in a statement.

“In addition, the performance of NVX-CoV2373 in multiple preclinical studies and testing gives us increased confidence in its potential to protect against COVID-19 disease,” he added.

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