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Research programme: recombinant protein subunit vaccines - Hawaii Biotech

Drug Profile

Research programme: recombinant protein subunit vaccines - Hawaii Biotech

Latest Information Update: 28 Mar 2020

At a glance

  • Originator Hawaii Biotech
  • Class Parasitic vaccines; Recombinant proteins; Subunit vaccines; Viral envelope proteins; 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

  • No development reported Crimean-Congo haemorrhagic fever virus infections; Encephalitis virus infections; Malaria; Zika virus infection

Most Recent Events

  • 28 Mar 2020 No recent reports of development identified for preclinical development in Zika-virus-infection in USA (Parenteral)
  • 28 Mar 2018 No recent reports of development identified for research development in Crimean-Congo-haemorrhagic-fever-virus-infections in USA (Parenteral)
  • 30 Aug 2016 Hawaii Biotech receives SBIR grant from National Institute of Allergy and Infectious Disease (NIAID) for vaccine development in Chikungunya

Development Overview

Introduction

Hawaii Biotech is developing vaccines against tick-borne encephalitis, malaria and Crimean-Congo haemorrhagic fever, chikungunya and Zika virus infections. The company plans to use its proprietary recombinant protein production platform to produce the subunit vaccines. The tick-borne encephalitis vaccine is being developed containing the tick-borne encephalitis envelope glycoprotein; the infection is caused by a virus that is a member of the family Flaviviridae. Hawaii Biotech is developing its malaria subunit vaccine in collaboration with researchers from the University of Hawaii-Manoa. Development is at the preclinical stage for the encephalitis, chikungunya virus, Zika virus infections and malaria vaccines, and under early research for the Crimean-Congo haemorrhagic fever virus infections vaccine, in the US.

As at July 2016, no recent reports of development had been identified for preclinical development in Encephalitis-virus-infections in USA (Parenteral), preclinical development in Malaria in USA (Parenteral).

As at March 2018, no recent reports of development had been identified for research development in Crimean-Congo-haemorrhagic-fever-virus-infections in USA (Parenteral).

As at March 2020, no recent reports of development had been identified for preclinical development in Zika-virus-infection in USA (Parenteral).

Company Agreements

In November 2011, Merck and Co (via the subsidiary Merck Sharpe and Dohme) granted Hawaii Biotech an exclusive license to vaccine technology for tick-borne encephalitis and malaria, and a non-exclusive license for recombinant protein expression technology. These technologies were previously developed by Hawaii Biotech and acquired by Merck as part of a transaction in 2010 [1] .

Key Development Milestones

In August 2016, Hawaii Biotech received a Small Business Innovation Research (SBIR) phase I grant from The National Institute of Allergy and Infectious Diseases, to develop a vaccine to protect against infection caused by the mosquito-borne chikungunya virus. Hawaii Biotech will be collaborating with Baylor College of Medicine and the Sabin Vaccine Institute on this joint award [2] .

In August 2009, Hawaii Biotech received a three-year Small Business Innovation Research (SBIR) Phase II grant from the National Institute of Allergy and Infectious Disease (NIAID) to continue development of a vaccine to protect healthy subjects from tick-borne encephalitis. The company stated that the funding would enable completion of preclinical development and preparation for clinical trials of the vaccine. The funds would be used to establish safety, immunogenicity and efficacy of the vaccine in suitable animal models [3] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Parasitic vaccines, Recombinant proteins, Subunit vaccines, Viral envelope proteins, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-A (Encephalitis vaccines)

    J07B-X (Other viral vaccines)

    J07X (Other vaccines)

    P01B-X (Other antimalarials)

  • EPhMRA code

    J7A9 (Other specified single component)

    J7C (All Other Vaccines)

    J7E9 (All other viral vaccines)

    P1D (Anti-Malarials)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Crimean-Congo haemorrhagic fever virus infections - - No development reported (Research) USA Parenteral / unspecified Hawaii Biotech 28 Mar 2018
Encephalitis virus infections - - No development reported (Preclinical) USA Parenteral / unspecified Hawaii Biotech 16 Jul 2016
Malaria - - No development reported (Preclinical) USA Parenteral / unspecified Hawaii Biotech 16 Jul 2016
Zika virus infection - - No development reported (Preclinical) USA Parenteral / unspecified Hawaii Biotech 28 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Hawaii Biotech Originator USA
Hawaii Biotech Owner USA
Merck Sharp & Dohme Technology Provider England
National Institute of Allergy and Infectious Diseases Funder USA
Sabin Vaccine Institute Collaborator USA
Baylor College of Medicine Collaborator USA

Development History

Event Date Update Type Comment
28 Mar 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection in USA (Parenteral) Updated 28 Mar 2020
28 Mar 2018 Phase Change - No development reported No recent reports of development identified for research development in Crimean-Congo-haemorrhagic-fever-virus-infections in USA (Parenteral) Updated 28 Mar 2018
30 Aug 2016 Company Involvement Hawaii Biotech receives SBIR grant from National Institute of Allergy and Infectious Disease (NIAID) for vaccine development in Chikungunya [2] Updated 01 Sep 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Encephalitis-virus-infections in USA (Parenteral) Updated 16 Jul 2016
16 Jul 2016 Phase Change - No development reported No recent reports of development identified for preclinical development in Malaria in USA (Parenteral) Updated 16 Jul 2016
03 Feb 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection in USA before February 2016 (Parenteral) (Hawaii Biotech pipeline, February 2016) Updated 03 Feb 2016
04 Feb 2014 Phase Change Early research in Crimean-Congo haemorrhagic fever virus infections in USA (Parenteral) Updated 11 Mar 2014
01 Nov 2011 Phase Change - Preclinical Preclinical trials in Malaria in USA (Parenteral) Updated 02 Nov 2011
11 Aug 2009 Company Involvement Hawaii Biotech receives SBIR grant from National Institute of Allergy and Infectious Disease (NIAID) for vaccine development in Tick-borne encephalitis Updated 17 Aug 2009
11 Aug 2009 Phase Change - Preclinical Preclinical trials in Encephalitis virus infections in USA (Parenteral) Updated 17 Aug 2009

References

  1. Hawaii Biotech Licenses Vaccine Technology From Merck.

    Media Release
  2. Hawaii Biotech Awarded Grant To Develop Chikungunya Virus Vaccine.

    Media Release
  3. Hawaii Biotech Receives Tick-Borne Encephalitis Vaccine Grant.

    Media Release
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