Novavax continues to advance its late-stage clinical program for a Covid-19 vaccine candidate, amid the ongoing search for a defense against the coronavirus and end to the pandemic.
The Montgomery County biotech expects to start its pivotal trial in the U.S. and Mexico by the end of November, rather than mid-October as originally planned, after both “significant progress in large-scale manufacturing” and “delays experienced versus original timing estimates,” Novavax said Tuesday in a release.
“Process development and scale-up to large scale commercial manufacturing is all part of a complex process and it all takes time,” Novavax said in an email to the Washington Business Journal.
The study entails enrollment of up to 30,000 participants across diverse populations — in age, race and ethnicity, and comorbidities — most vulnerable to the virus. It will use production from Tokyo-based Fujifilm Diosynth Biotechnologies' Morrisville, North Carolina, site, through the companies' partnership.
The company’s trial in the United Kingdom, which started at the end of September, is moving ahead, also with changes. It now has 5,500 volunteers enrolled toward a larger target than originally planned, up from 10,000 to 15,000 participants. That increase is designed to help assess safety and efficacy of the candidate, NVX-CoV2373, “in a shorter time period,” Novavax said.
“We are grateful for the support of the U.K. Government’s Vaccines Taskforce (VTF) and the National Institute for Health Research (NIHR) for our pivotal trial,” said Dr. Gregory Glenn, Novavax’s president of research and development, in a statement. “Recognizing the recent, large increase in the number of COVID-19 cases in the U.K., as well as the rapid progress in participant enrollment for our trial, in consultation with the VTF and NIHR, we adjusted our plans and increased enrollment.”
The company expects to reach full enrollment in the U.K. by the end of November, with the potential for interim data as soon as early in 2021 “dependent on the overall Covid-19 attack rate,” it said. Data from this study would serve as a foundation to seek regulatory approvals globally, according to Novavax.
Novavax’s stock was trading up 5% to $91.76 per share Tuesday morning.
The company has posted its protocol for this trial on its website, and said it plans to do the same for its U.S. study when it begins.
Novavax, meanwhile, has resumed work on its seasonal flu vaccine program, after pressing pause earlier this year to focus on its Covid-19 vaccine program. In doing so, the Gaithersburg biotech has promoted Russell “Rip” Wilson, its senior vice president of business development since 2011, to executive vice president and NanoFlu general manager — a new position created to focus on advancing its NanoFlu seasonal flu vaccine candidate. He’s heading up a new, separate development unit within the company focused on the flu program, which had come out of late-stage trials in March with positive data. He’ll also lead the charge in exploring a potential combined flu and Covid-19 vaccine “that could be used in a postpandemic setting,” the company said in mid-October.
Novavax is also hiring, looking to bring on more than 100 employees this year across the business, the company said in a recent email to the WBJ. It now has more than 90 open positions.
And to accommodate that growth — and support its NanoFlu program —the biotech is now working to finalize plans for an expansion, it said to the WBJ, declining to provide further details. But that growth has already started, with a recently inked lease for lab space at 704 Quince Orchard Road in Gaithersburg.
