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Research programme: antiviral vaccines - Vaxart

Drug Profile

Research programme: antiviral vaccines - Vaxart

Alternative Names: Chikungunya vaccine - Vaxart; Hepatitis B vaccine - Vaxart; Herpes simplex virus vaccine - Vaxart; Zika virus vaccine - Vaxart

Latest Information Update: 03 Mar 2021

At a glance

  • Originator Vaxart
  • Class Hepatitis B vaccines; Papillomavirus vaccines; Synthetic vaccines; Viral 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

  • Discontinued Chikungunya virus infections; Hepatitis B; Herpes simplex virus infections; Herpes simplex virus type 2 infections; Zika virus infection

Most Recent Events

  • 24 Feb 2021 Vaxart files for patent protection for proprietary technology, VAAST™ platform, and creations for oral vaccination using adenovirus and TLR3 agonists in USA and other countries
  • 28 Dec 2020 No recent reports of development identified for preclinical development in Herpes simplex virus type-2 infections in USA (PO, Tablet)
  • 28 Dec 2020 No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA (PO, Tablet)

Development Overview

Introduction

Orally administered vaccines are being developed by Vaxart, for the prevention of viral infections including chikungunya virus and zika virus infection, and a therapeutic vaccine for herpes simplex virus (HSV), including HSV 2. The vaccines are based on the company's oral recombinant vaccines technology, VAAST™ platform, and are composed of a non-replicating chimeric adenovirus-5 (Ad5) vector as a delivery vehicle, and a toll-like-receptor-3 (TLR) ligand as a vaccine adjuvant. Direct delivery of the vaccines into the gut using the Ad5 vector is expected to avoid neutralisation of the vaccine by immune cells based in the blood or muscle tissue. Vaxart's vaccines are produced using a standardised manufacturing method that is essentially the same for each vaccine, enabling rapid production of new vaccines against emerging pathogens. Potential advantages of the oral vaccines over injected vaccines include ease of administration, stability at ambient temperatures, reduced distribution costs, reduced medical waste and risk of needle-stick injury associated with injectable vaccines, and increased safety over other vaccines that contain killed or attenuated virus strains. Development was at the preclinical, proof-of-concept stage in the US.

A lead vaccine from this programme, respiratory syncytial virus vaccine oral, has entered clinical development [see Adis Insight Drug profile 800045759] and another vaccine product for the prevention of norovirus infection has also entered clinical development [see Adis Insight Drug profile 800047121]

Vaxart is also developing oral vaccines for the prevention of influenza virus infections, and vaccines for use in biodefense purposes [see Adis Insight Drug profiles 800030309, 800037541].

As at July 2016, no recent reports of development had been identified for preclinical development in Herpes-simplex-virus-infections in USA. As at October 2015, no recent reports on development of vaccine for hepatitis B were identified. As at December 2020, no recent reports of development had been identified for preclinical development in Herpes simplex virus type-2 infections in USA (PO, Tablet), preclinical development in Zika-virus-infection (Prevention) in USA (PO, Tablet).

As at March 2021, the development of vaccines for Chikungunya, Herpes-simplex-virus-infections, Herpes simplex virus type-2 infections, and Zika-virus-infection (Prevention) in USA (PO, Tablet) has been discontinued by Vaxart.

Key Development Milestones

Chikungunya virus infections

In April 2018, Vaxart presented positive immunogenicity data for a recombinant adenovirus vaccine vector was made that expresses the structural proteins of chikungunya virus at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID- 2018). The data demonstrated that the construct was highly immunogenic when administered in BALB/c and C57BL/6 mice after a single or a two-dose vaccination schedule. Additionally, immunization of CL57BL/6 mice with this vaccine construct generated high levels of chikungunya virus neutralizing antibodies and prevented footpad swelling and viremia in animals challenged with the chikungunya virus infection [1] .

Zika virus infections

In March 2016, Vaxart announced the initiation of preclinical trials for its oral recombinant vaccine against Zika virus infections [2] .

Herpes simplex virus infections (HSV)

Vaxart is also conducting preclinical studies of tablet vaccine candidates for RSV and HSV 2 [3] . The tablet vaccine is in proof-of-concept investigation in guinea pig model.

As at October 2015, no recent reports on development of vaccine for hepatitis B were identified.

Patent Information

Prior to February 2021, Vaxart has filed broad domestic in USA and international patents covering its proprietary technology, VAAST™ platform, and creations for oral vaccination using adenovirus and TLR3 agonists [4] .

In July 2011, Vaxart was issued US patent No. 7 879 602, which covers the company's re-usable oral-delivery platform technology [5] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Tablet, unspecified
  • Class Hepatitis B vaccines, Papillomavirus vaccines, Synthetic vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-C (Hepatitis vaccines)

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7A9 (Other specified single component)

    J7E4 (Hepatitis vaccines)

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Chikungunya virus infections - Prevention Discontinued (Preclinical) USA unspecified / unspecified Vaxart 19 Oct 2020
Hepatitis B - Prevention Discontinued (Preclinical) USA PO / unspecified Vaxart 19 Oct 2020
Herpes simplex virus infections - Prevention Discontinued (Preclinical) USA PO / unspecified Vaxart 19 Oct 2020
Herpes simplex virus type 2 infections - Prevention Discontinued (Preclinical) USA PO / Tablet Vaxart 19 Oct 2020
Zika virus infection - Prevention Discontinued (Preclinical) USA PO / Tablet Vaxart 19 Oct 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Vaxart Originator USA
Vaxart Owner USA

Scientific Summary

Pharmacodynamics

Summary

In preclinical trial, chikungunya vaccine elicited neutralizing antibodies and protected mice against chikungunya virus induced footpad swelling [6] .

Development History

Event Date Update Type Comment
24 Feb 2021 Patent Information Vaxart files for patent protection for proprietary technology, VAAST™ platform, and creations for oral vaccination using adenovirus and TLR3 agonists in USA and other countries [4] Updated 26 Feb 2021
28 Dec 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Herpes simplex virus type-2 infections in USA (PO, Tablet) Updated 28 Dec 2020
28 Dec 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA (PO, Tablet) Updated 28 Dec 2020
19 Oct 2020 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for Chikungunya virus infections (Prevention) in USA (unspecified route) Updated 03 Mar 2021
19 Oct 2020 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for Hepatitis B (Prevention) in USA (PO) Updated 03 Mar 2021
19 Oct 2020 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for Herpes simplex virus infections (Prevention) in USA (PO) Updated 03 Mar 2021
19 Oct 2020 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for Herpes simplex virus type 2 infections (Prevention) in USA (PO) Updated 03 Mar 2021
19 Oct 2020 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for Zika virus infection (Prevention) in USA (PO) Updated 03 Mar 2021
30 May 2019 Scientific Update Pharmacodynamics data from a preclinical study in Chikungunya virus infection released by Vaxart [6] Updated 03 Jun 2019
21 Apr 2018 Phase Change - Preclinical Preclinical trials in Chikungunya virus infections (Prevention) in USA before April 2018 [1] Updated 08 May 2018
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Herpes-simplex-virus-infections in USA (PO) Updated 16 Jul 2016
03 Mar 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection (Prevention) in USA (PO) [2] Updated 07 Mar 2016
30 Oct 2015 Phase Change - No development reported(Preclinical) No development reported - Preclinical for Hepatitis B (Prevention) in USA (PO) Updated 30 Oct 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Herpes simplex virus type-2 infections in USA (PO) Updated 10 Jan 2015
01 Feb 2013 Phase Change - Preclinical Preclinical trials in Hepatitis B in USA (PO) Updated 13 Feb 2013
01 Feb 2013 Phase Change - Preclinical Preclinical trials in Herpes simplex virus infections in USA (PO) Updated 13 Feb 2013

References

  1. Mateo R, Dora E, Rossi S, Weaver S, Tucker S. An oral vaccine approach against chikungunya virus (CHIKV). ECCMID-2018 2018; abstr. O0886.

    Available from: URL: http://www.eccmidlive.org/#resources/an-oral-vaccine-approach-against-chikungunya-virus-chikv
  2. Vaxart Begins Preclinical Testing of an Oral Zika Virus Vaccine.

    Media Release
  3. Vaxart Completes Financing to Fund Expanding Development Portfolio.

    Media Release
  4. Vaxart to Provide 2021 Business Outlook on Tuesday, March 2, 2021.

    Media Release
  5. Vaxart Begins First Oral Vaccine Clinical Trial.

    Media Release
  6. New Publication in Vaccine Highlights Preclinical Results of Vaxarts Mucosal Chikungunya Vaccine.

    Media Release
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