Novavax Identifies COVID-19 Vaccine Candidate, Human Testing To Begin In Mid-May

Novavax, Inc. NVAX, which has been working on a vaccine to treat the new coronavirus that causes COVID-19, announced Wednesday that it has identified a candidate, NVX-CoV2373.

The vaccine candidate is a stable prefusion protein made using Novavax's proprietary nanoparticle technology, according to the company. Novavax said its proprietary Matrix-M adjuvant will be incorporated into the vaccine candidate to enhance its immune response and stimulate high levels of neutralizing antibodies.

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Antibodies Seen After Single Immunization

With NVX-CoV2373, a high level 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, Novavax said. 

Additionally, high microneutralization titers, which are considered evidence that a vaccine is likely to be protective in humans, increased eight-fold with a second dose, the company said. 

"This is strong evidence that the vaccine created by Novavax has the potential to be highly immunogenic in humans which could lead to protection from COVID-19 and helping to control the spread of this disease," Matthew Frieman, associate professor at the University of Maryland School of Medicine, said in a statement. 

Novavax's Clinical Development Timeline, Plan

Novavax said it is working closely with Emergent Biosolutions Inc EBS to transfer its production technology to manufacture a GMP vaccine for clinical trials.

The company plans to combine a Phase 1/2 approach to rapidly advance the vaccine candidate. The Phase 1 trial is a placebo-controlled, observer-blinded study of about 130 healthy volunteers that will assess the dosage amount and number of vaccinations.

Novavax said it expects to commence the study in mid-May and release preliminary immunogenicity and safety results in July — weeks ahead of schedule. 

At last check, Novavax shares were adding 11.64% to $16.63.

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