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Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.
Emergent BioSolutions is pursuing different avenues of therapy for the coronavirus (COVID-19). On March 18, 2020, the company announced an agreement with Vaxart, a clinical-stage biotechnology company, for an oral vaccine candidate. Earlier in the month, the company announced that it is developing antibody therapeutics for treating the disease in.
Under the agreement with Vaxart, Emergent will use its contract development and manufacturing (CDMO) services to develop and manufacture Vaxart’s experimental oral vaccine candidate for COVID-19. Development services will begin immediately, and, upon Vaxart’s election, Emergent will produce clinical material that will enable Vaxart to initiate a Phase I clinical study, which is anticipated for early in the second half of 2020. Vaxart’s oral recombinant vaccine candidate is based on its proprietary variant annotation analysis and search tool (VAAST) platform.
Emergent will provide development services out of its Gaithersburg, MD, location and manufacture drug substance at its Bayview facility in Baltimore, MD. The Baltimore site is a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the United States Department of Health and Human Services. This facility has the capacity to produce tens to hundreds of millions of doses of vaccine annually, based on the company’s platform technology. Additionally, it is capable of producing at clinical scale and in parallel, allowing scale-up to produce commercial volumes.
“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 at Emergent BioSolutions, in a company press release.
“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,” said Wouter Latour, MD, CEO of Vaxart, in the press release. “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.”
Meanwhile, on March 11, 2020, Emergent announced that it began development of plasma-derived product candidates. The company is developing two product candidates using its hyperimmune platforms, which comprise polyclonal antibody therapeutics derived from plasma. These antibodies leverage the immune response in humans or animals and can provide immediate protection from infection, the company has reported.
One product candidate, COVID-HIG, manufactured from human plasma with antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), will be developed as a potential treatment for severely ill hospitalized patients as well as protection for at-risk individuals. The second product candidate, COVID-EIG, manufactured from plasma of immunized horses with antibodies to SARS-CoV-2, will be developed in parallel as a potential treatment for severely ill hospitalized patients.
Emergent has initiated plasma collection efforts for both human and equine platforms with a goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter of 2020.
The company’s hyperimmune platforms and related in-house manufacturing infrastructure support several products approved by FDA, including the company’s treatments for smallpox vaccine complications, botulism, and anthrax, VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine)], and Anthrasil [Anthrax Immune Globulin Intravenous (Human)], respectively.
“As a company focused on public health threats, we are committed to responding to this novel coronavirus and will use our broad capabilities and platforms to advance solutions. On the heels of our collaboration with an industry partner to develop an experimental vaccine candidate for clinical testing, we are pleased to leverage our existing infrastructure to help expedite development of our product candidates for COVID-19, founded on our decades of experience in hyperimmune manufacturing,” said Robert G. Kramer Sr., president and CEO at Emergent BioSolutions, in a company press release.
“Emergent is advancing these programs based on our hyperimmune platforms and using existing infrastructure and capabilities that we deployed for our recently completed Phase [II] clinical trial for our influenza hyperimmune FLU-IGIV to treat patients hospitalized with Influenza A,” said Laura Saward, senior vice-president and therapeutics business unit head at Emergent BioSolutions, in the press release. “By leveraging our platform and capabilities that are already in place, Emergent is in a state of readiness to develop treatment options for COVID-19 to potentially protect healthcare workers and others on the frontline, as well as treat individuals who have fallen ill.”