Editor’s Note: This story first appeared in the Washington Business Journal. It appears here in an abbreviated format. See the original post here.
Novavax is taking its coronavirus vaccine program to the next stage faster than expected, despite the remaining challenge of securing more funding and support for the program.
The Gaithersburg biotech has identified the candidate it will take to its first phase of clinical trials, now with an expectation of starting its first human study a few months sooner than planned, in mid-May, the company said early Wednesday. The company is positioned to have preliminary data from this study, which will just test the candidate's safety levels in humans, in July.
The candidate Novavax has decided to advance, called NVX-CoV2373, successfully produced immune responses and produced high levels of antibodies against the novel coronavirus in preclinical animal tests, said Dr. Gregory Glenn, Novavax’s president of research and development, in a statement.
“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,” said Matthew Frieman, associate professor at the University of Maryland School of Medicine, in a statement. Frieman worked with Novavax to identify the vaccine candidate.
Novavax is working with neighboring biotech Emergent BioSolutions Inc. (NYSE: EBS) to push this vaccine forward on a tight timeline — as well as Novavax's flagship flu vaccine, which successfully emerged from a phase 3 trial toward the end of March. Novavax also has a $4 million investment from the Coalition for Epidemic Preparedness Innovations.
But the company will need a lot more cash — hundreds of millions of dollars — to get its coronavirus program through regulatory approval, which could still take more than a year. Such testing normally requires two more, larger phases of human clinical trials before the approval process even begins.
