Emergent BioSolutions has struck an agreement with Vaxart, a clinical-stage biotechnology company, to develop and manufacture Vaxart’s experimental oral vaccine candidate for the COVID-19 coronavirus.
As part of the deal, Emergent will utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop the vaccine.
Development services will begin immediately. Emergent will produce clinical material expected to enable Vaxart to initiate a Phase 1 clinical study anticipated early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST platform.
“Emergent is pleased to deploy our nimble CDMO expertise to support fellow innovators, like Vaxart, and advance an experimental COVID-19 vaccine candidate,” Syed Husain, senior vice president and CDMO business unit head at Emergent BioSolutions, said. “We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxart’s potential need for future scalability and large-scale capacity for commercial quantities.”
Emergent will provide development services out of its Gaithersburg, Md. office and manufacture drug substance at its Bayview facility in Baltimore, Md. The facility has been designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services.
The Bayview facility is also used to manufacture drug substance for the company’s recently announced Novavax collaboration. The facility has the capacity to produce tens to hundreds of millions of doses of vaccine annually, based on the platform technology being leveraged. It also has the capability of producing at clinical scale and getting vaccine candidates quickly into the clinic. It can also scale up to produce commercial volumes to meet customer demand.
“I’m pleased that we are joining forces with an experienced manufacturer such as Emergent to help advance our oral COVID-19 vaccine to the clinic,” Wouter Latour, chief executive officer of Vaxart, said. “We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign, and Emergent is a great partner to help in this endeavor.”