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COVID-19 vaccine - VAXART

Drug Profile

COVID-19 vaccine - VAXART

Alternative Names: Corona virus vaccine - VAXART

Latest Information Update: 29 Apr 2020

At a glance

  • Originator Vaxart
  • Class Viral vaccines; Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 21 Apr 2020 Immunogenicity data from a preclinical data in COVID-19 infections released by Vaxart
  • 19 Mar 2020 Vaxart signs development services agreement with Emergent BioSolutions for COVID-2019 vaccine development
  • 19 Mar 2020 Preclinical trials in COVID-2019 infections in USA (PO)

Development Overview

Introduction

A recombinant oral vaccine is being developed by Vaxart in collaboration with Emergent BioSolutions for the treatment of COVID-19 infections. Vaccine candidate is based on its proprietary VAAST™ platform. Preclinical development is underway in the US.

Company Agreements

In May 2020, Kindred Biosciences entered into an agreement with Vaxart for the manufacture of Vaxart's oral vaccine candidate for COVID-19. Under the terms of the agreement, KindredBio will provide manufacturing services from its biological development and cGMP manufacturing facility in Burlingame, CA. KindredBio will produce the candidate vaccine bulk drug substance under Good Manufacturing Practices, and provide it to Vaxart to be formulated into an oral tablet. KindredBio will manufacture the vaccine for clinical trials beginning in the second half of 2020.
[1]

In March 2020, Vaxart signed a development agreement with Emergent BioSolutions for the former's COVID-2019 candidate. Development services are to begin immediately and upon Vaxart’s election, Emergent is expected to produce bulk cGMP vaccine for a planned phase I trial. [2]

Key Development Milestones

In May 2020, Vaxart announced that it has chosen the lead candidate for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response [3] .

In March 2020, Vaxart had produced five COVID-19 vaccine candidates for testing in its preclinical models. Each of the COVID-19 vaccine constructs is based on a different coronavirus antigen combination, and Vaxart expects to advance the best performing vaccine to manufacturing for further clinical trials. Positive preclinical data were released by Vaxart in April 2020 [4] [5] [6] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Tablet
  • Class Viral vaccines, Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7A9 (Other specified single component)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical USA PO / Tablet Vaxart 19 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Vaxart Originator USA
Vaxart Owner USA
Emergent BioSolutions Collaborator USA

Scientific Summary

Immunogenicity

Summary

Oral administration of COVID-19 vaccine in animal models demonstrated statistically significant antibody responses in comparison to the control. IgG anti-SARS CoV-2 antibodies were observed in serum two weeks following first vaccination. Robust response was observed after both the first and second dose, with a clear boosting effect after the second dose. In all vaccinated groups, antibody responses were statistically significant (p < 0.002), with median ELISA IgG antibody titers more than 10 000 compared to a median titer of 1 in the untreated controls indicating a larger than 10 000 fold increase [4] [5] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Trial Update Vaxart plans a phase I trial for COVID-19 in USA in the second half of 2020 (PO) (700320031) [7] 26 Mar 2020

Development History

Event Date Update Type Comment
21 Apr 2020 Scientific Update Immunogenicity data from a preclinical data in COVID-19 infections released by Vaxart [5] [4] Updated 29 Apr 2020
19 Mar 2020 Licensing Status Vaxart signs development services agreement with Emergent BioSolutions for COVID-2019 vaccine development [2] Updated 24 Mar 2020
19 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (PO) Updated 23 Mar 2020
18 Mar 2020 Trial Update Vaxart plans a phase I trial for COVID-19 in USA in the second half of 2020 (PO) [7] Updated 26 Mar 2020

References

  1. Kindred Biosciences Announces COVID-19 Vaccine Manufacturing Agreement with Vaxart.

    Media Release
  2. Vaxart Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update.

    Media Release
  3. Vaxart Announces Selection of its Oral COVID-19 Vaccine Lead Candidate.

    Media Release
  4. Vaxart Announces First Quarter 2020 Financial Results and Provides Corporate Update.

    Media Release
  5. Vaxart Announces Positive Pre-Clinical Data for its Oral COVID-19 Vaccine Program.

    Media Release
  6. Vaxart Provides Update on its Oral COVID-19 Vaccine Program.

    Media Release
  7. EMERGENT BIOSOLUTIONS SIGNS DEVELOPMENT AND MANUFACTURING AGREEMENT WITH VAXART FOR THEIR EXPERIMENTAL ORAL VACCINE CANDIDATE FOR CORONAVIRUS DISEASE.

    Media Release
  8. VAXART ANNOUNCES IT ENTERED INTO AN AGREEMENT WITH EMERGENT BIOSOLUTIONS FOR THE DEVELOPMENT AND MANUFACTURING OF ORAL CORONAVIRUS (COVID-19) VACCINE CANDIDATE.

    Media Release
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