Vaxart Announces Selection of its Oral COVID-19 Vaccine Lead Candidate

KindredBio Selected as Second Contract Manufacturing Organization

GMP Production for Phase 1 Study Initiated

SOUTH SAN FRANCISCO, CA, USA I May 20, 2020 I Vaxart, Inc. (“Vaxart” or the “Company”) (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that it has selected its lead COVID-19 vaccine candidate and has contracted with KindredBio to manufacture bulk vaccine under cGMP to complement the manufacturing capacity of partner Emergent BioSolutions.

“All our COVID-19 vaccine constructs were highly immunogenic in preclinical testing, and we are taking the candidate forward that is expected to generate the broadest immune response in humans,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “In a phase 2 efficacy study that was recently published in the Lancet Infectious Diseases, we have demonstrated that our oral H1 flu tablet vaccine protected against influenza infection after just one dose.  Based on these results, we believe our vaccines are ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes COVID-19.”

In January 2020, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAASTTM oral vaccines platform. The Company evaluated multiple vaccine candidates in its preclinical models and has chosen the lead candidate for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response. Vaxart has contracted with Emergent BioSolutions (“Emergent”) and Kindred Biosciences, Inc. (“KindredBio”) to produce bulk vaccine under cGMP for upcoming clinical trials.  The vaccine tablets will be manufactured at Vaxart.

“We are very pleased to have an experienced partner such as KindredBio to help us meet global demand for our COVID-19 vaccine,” said Wouter Latour, MD, chief executive officer of Vaxart. “The program with Emergent BioSolutions is progressing very well, and we expect KindredBio will add additional capacity to help produce bulk vaccine.  An important benefit of our platform is that our vaccines are produced in tablet form and we don’t need the sterile fill and finish that is required for the production of injectable vaccines.  Manufacturing of our COVID-19 vaccine is on track to start a first phase 1 study in the second half of this year, possibly as early as the summer.”

About Vaxart
Vaxart is a clinical-stage biotechnology company primarily focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxart’s vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer. Vaxart’s vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tablet vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (“RSV”), as well as a therapeutic vaccine for human papillomavirus (“HPV”). For more information, please visit www.vaxart.com.

SOURCE: Vaxart

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