Biopharma companies are attacking the COVID-19 pandemic from many fronts. Emergent BioSolutions is among those leading the fight.
Biopharma companies are attacking the COVID-19 pandemic from many fronts. Emergent BioSolutions is among those leading the fight. The company has a proven track record, partners and extensive networks to advance vaccines or therapeutics quickly toward trials.
Emergent BioSolutions supplies the Strategic National Stockpile with vaccines against anthrax and smallpox, and treatments against anthrax, botulism and smallpox vaccine complications. Its pipeline includes vaccines against Chikungunya and anthrax (again), treatments targeting Zika and Influenza A, and now, COVID-19.
The company plans to take its COVID-19 treatments directly into Phase II trials – bypassing Phase I – in late summer.
“We have seven approved products on our platforms, manufacturing is scaled up and the assays are validated, so we only have to add the COVID-specific assays. That reduces the steps required to get to clinical trials,” Laura Saward, Ph.D., SVP and therapeutics business unit head, told BioSpace.
Emergent’s antibody therapeutics platform is key in its COVID-19 fight.
“It generates antibodies using two approaches,” Saward said. “One collects convalescent serum from recovered COVID-19 patients. The other does much the same, purifying antibodies from inoculated horses. Both aim to prevent the severity of the disease and thus limit disease progression.”
Of the two approaches, “the equine platform is more scalable. We can vaccinate more horses and get plasma more quickly, but this method doesn’t produce a fully human antibody. Therefore, we remove part of that antibody to make it safe for humans,” Saward said.
But that’s not the sum of Emergent’s contributions. It also is a contract development and manufacturing organization (CDMO). It recently signed contracts to help Vaxart, based in South San Francisco, and Novavax, headquartered in Gaithersburg, Maryland, develop COVID-19 vaccines.
For Vaxart, Emergent is producing clinical materials for a Phase I study for an oral recombinant vaccine based on Vaxart’s proprietary VAAST™ platform. The most successful candidate will be advanced to Phase I trials, which are expected to begin early in the second half of 2020.
For Novavax, Emergent is producing an experimental vaccine based on Novavax’s proprietary recombinant protein nanoparticle technology platform. It uses proprietary Matrix-M™ adjuvant to enhance immune responses. A Phase I clinical study is anticipated to begin in June.
Emergent also is manufacturing a seasonal flu vaccine for Novavax. NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, was made using the Matrix-M™ adjuvant. It met all primary objectives in its Phase III clinical trial, which evaluated immunogenicity and safety in adults aged 65 and older.
To support these and other endeavors, “We have a broad spectrum of capabilities in-house and through partnering,” Dr. Saward added. Emergent has 19 locations. Nine are development and manufacturing facilities, mostly in North America. The company has a product development facility in Southern California.
Emergent is just one of the companies actively engaging in the COVID-19 fight. More are joining that battle daily, developing diagnostics, vaccines and therapeutics, as well as funding foundations and relief efforts, and making critical resources available to make troubling times at least a little less troubling.
