Emergent BioSolutions has entered into an agreement with Vaxart, a clinical-stage biotechnology company, whereby Emergent has agreed to utilize its molecule-to-market contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for coronavirus disease (COVID-19). Development services will begin immediately, and upon Vaxart’s election, Emergent agrees to 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,” said Syed T. Husain, senior vice president and CDMO business unit head, Emergent BioSolutions. “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 location and manufacture drug substance at its Bayview facility in Baltimore, MD, designated a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services. Emergent’s Bayview CIADM is the same facility 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 on an annual basis, based upon the platform technology being leveraged. Additionally, it has the unique capability of producing at clinical scale, to get vaccine candidates quickly into the clinic, and in parallel, scaling up to produce commercial volumes to meet customer demand.
 
Wouter Latour, chief executive officer, Vaxart, said, “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. 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.”