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Research programme: coronavirus vaccines - Soligenix/University of Hawaii

Drug Profile

Research programme: coronavirus vaccines - Soligenix/University of Hawaii

Alternative Names: COVID-2019 vaccine - Soligenix; SARS-CoV-2 virus vaccine - Soligenix

Latest Information Update: 20 Apr 2020

At a glance

  • Originator Soligenix; University of Hawaii
  • Class Subunit 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

  • Research Coronavirus infections; COVID 2019 infections

Most Recent Events

  • 16 Apr 2020 Soligenix signs agreement with Protherics for CoVaccine adjuvant
  • 23 Mar 2020 Soligenix expands collaboration with University of Hawaii at Mānoa to develop thermostable vaccines for Coronavirus infections and COVID-2019 infections
  • 23 Mar 2020 Early research in Coronavirus infections (Prevention) in USA (Parenteral)

Development Overview

Introduction

Soligenix, in collaboration with the University of Hawaii at Mānoa is developing thermostable alum adjuvanted coronavirus vaccines for protection against coronavirus infections including COVID-2019 infections. Soligenix will utilise ThermoVax® technology which was in-licensed from the University of Colorado, to stabilise components of the vaccines at high temparature. The vaccines will be based on well-defined surface glycoprotein(s) from one or more coronaviruses, including SARS-CoV-2 virus. Initially, the company will focus the development on a SARS-CoV-2 virus vaccine, for the treatment of COVID-2019 infections. Early research is underway in the US.

The vaccines will be made from purified surface glycoprotein(s) from one or more coronaviruses, which will be manufactured with a proprietary insect cell expression system and aluminum salt, (known colloquially as Alum) as an adjuvant to activate cell as well as humoral immunity in heat stable formulation. The Alum adjuvanted vaccines, manufactured using ThermoVax® technology eliminate the need for cold chain production and transportation.

Company Agreements

In April 2020, Soligenix signed an agreement with BTG for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant. CoVaccine HT is component of Soligenix's vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. [1]

In March 2020, Soligenix and John A. Burns School of Medicine (JABSOM), University of Hawai'i at Manoa (UH Manoa) expanded the collaboration to develop thermostable coronavirus vaccines; including a vaccine for COVID-2019 infections. Earlier in May 2015, Soligenix entered into a collaboration agreement with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawai'i at Manoa (UH Manoa) and Hawaii Biotech, Inc. (HBI) to develop a heat stable subunit Ebola vaccine. Under the terms of the agreement, Soligenix will evaluate its proprietary vaccine thermostabilization technology, ThermoVax™, licensed from the University of Colorado, to stabilize components of the vaccine. Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage. [2] [3]

In January 2011, Soligenix, Inc. entered into a definitive license agreement with the University of Colorado (CU) for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures. Soligenix has been developing this stabilization technology under an option-to-license agreement from CU that was initiated to support the technology development efforts funded by a $US9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The license agreement has an expanded scope for thermostable vaccines for biodefense as well as all potential vaccine indications. The novel technology involves the use of several unique process and formulation steps that fix sensitive vaccine ingredients in native configuration. For biodefense indications, the company is using the stabilization technology to advance RiVax(TM), its subunit vaccine against ricin toxin, as well a subunit vaccine for anthrax prevention. The underlying technology has been developed by Drs. Amber Clausi, John Carpenter and Theodore Randolph at CU-Boulder. The terms of the license were not disclosed. [4]

Drug Properties & Chemical Synopsis

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

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Research USA Parenteral / unspecified Soligenix, University of Hawaii 23 Mar 2020
Coronavirus infections - Prevention Research USA Parenteral / unspecified Soligenix, University of Hawaii 23 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
University of Hawaii Originator USA
Soligenix Originator USA
University of Hawaii Owner USA
Soligenix Owner USA
University of Colorado at Boulder Technology Provider USA
Protherics Collaborator United-Kingdom

Development History

Event Date Update Type Comment
16 Apr 2020 Licensing Status Soligenix signs agreement with Protherics for CoVaccine adjuvant [1] Updated 20 Apr 2020
23 Mar 2020 Licensing Status Soligenix expands collaboration with University of Hawaii at Mānoa to develop thermostable vaccines for Coronavirus infections and COVID-2019 infections [3] Updated 28 Mar 2020
23 Mar 2020 Phase Change Early research in Coronavirus infections (Prevention) in USA (Parenteral) [3] Updated 28 Mar 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (Parenteral) [3] Updated 28 Mar 2020
27 Jan 2011 Licensing Status Soligenix in-licenses vaccine thermostabilisation technology from the University of Colorado [4] Updated 28 Mar 2020

References

  1. Soligenix Announces Exclusive Licensing Agreement for Novel Vaccine Adjuvant from BTG Specialty Pharmaceuticals.

    Media Release
  2. Soligenix Announces Collaboration with the University of Hawai'i at Manoa and Hawaii Biotech to Develop Heat Stable Ebola Vaccine.

    Media Release
  3. Soligenix and University of Hawaii at Mnoa Initiate Work on Novel Coronavirus Vaccine for COVID-19.

    Media Release
  4. Soligenix Executes Exclusive License with the University of Colorado for Vaccine Thermostabilization Technology.

    Media Release
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