Novavax said Wednesday that its coronavirus vaccine candidate, dubbed NVX-CoV2373, will be evaluated in a Phase I clinical trial starting the middle of next month. The company said its Matrix-M adjuvant will be incorporated with NVX-CoV2373, a stable prefusion protein made using the firm's nanoparticle technology, in order to "enhance immune responses and stimulate high levels of neutralising antibodies."
The placebo-controlled study will enrol approximately130 healthy adults and includes assessment of dosage amount and number of vaccinations, the company said. Gregory Glenn, who heads R&D, indicated that recent funding from the Coalition for Epidemic Preparedness Innovations, together with the vaccine candidate's "excellent early results, put us in position to have preliminary human data in July."
According to Novavax, a single immunisation with NVX-CoV2373 in preclinical testing has been shown to induce "high levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralising antibodies." The company also pointed out that "the already high micro-neutralisation titers seen after one dose increased eight fold with a second dose."
CEO Stanley Erck said that "this progress demonstrates the ability of our recombinant nanoparticle technology to rapidly create vaccine candidates for emerging viruses like SARS-CoV-2."
Last month, Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with vaccine product for use in its clinical trials. The deal, which covers Novavax's recombinant quadrivalent seasonal influenza vaccine candidate NanoFlu, includes an option to allocate capacity for a potential scaled-up COVID-19 programme.
Earlier this week, Inovio Pharmaceuticals said the FDA authorised the company to move ahead with a Phase I trial of its experimental DNA vaccine candidate INO-4800 to prevent COVID-19 infections. Meanwhile, a Phase I clinical study of Moderna's experimental mRNA vaccine mRNA-1273 against SARS-CoV-2, partnered with the National Institute of Allergy and Infectious Diseases, dosed its first patient in the US in mid-March, with a mid-stage trial potentially getting underway "in a few months."
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