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Research programme: COVID-2019 vaccines - HaloVax/Massachusetts General Hospital

Drug Profile

Research programme: COVID-2019 vaccines - HaloVax/Massachusetts General Hospital

Alternative Names: HaloVax™ - HaloVax/Massachusetts General Hospital; SAV - HaloVax/Massachusetts General Hospital; Self-Assembling Vaccine - HaloVax/Massachusetts General Hospital

Latest Information Update: 17 Jun 2021

At a glance

  • Originator HaloVax; Massachusetts General Hospital
  • Class COVID-19 vaccines; Peptide 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

  • 17 Jun 2021 Hoth Therapeutics announces intention to complete IND-enabling studies in 2021
  • 09 Feb 2021 Voltron Therapeutics initiates preclinical studies for COVID-2019 infections (Prevention) in USA (Parenteral)
  • 09 Feb 2021 Voltron Therapeutics initiates preclinical studies for COVID-2019 infections in USA (Parenteral)

Development Overview

Introduction

A pipeline of COVID-2019 vaccine candidates are being jointly developed by HaloVax (a joint venture of Voltron Therapeutics and Hoth Therapeutics), and Vaccine and Immunotherapy Center (VIC) of the Massachusetts General Hospital (MGH), to prevent, intercept or treat COVID-2019 infections. The company intends to utilise VaxCelerate, a self-assembling vaccine (SAV) platform, exclusively licensed by Voltron from the VIC at MGH, for the development of the vaccine candidates. The two lead vaccine candidates are built on a base of a heat shock protein (HSP70) bound at high affinity to the immunogenic peptides from the COVID-2019 virus via Avidin and Biotin. Preclinical development is underway in the US.

The bacterial heat shock protein (HSP70) portion of the vaccine is extremely potent at presenting vaccine antigens to immune cells, resulting in both antibody and cell-mediated immunity. The avidin portion of the vaccine enables rapid iteration and change in the antigen to enable rapid production and accommodate potential changes in the pathogen, or new evolving pathogens. The vaccine focuses on both DNA and internal / external mutated proteins providing the immune system with more potential targets to attack.

Company Agreements

In March 2020, HaloVax entered into a licensing agreement with Hoth Therapeutics, to advance an application of a self-assembling vaccine (SAV) platform from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH). The agreement is to develop a vaccine designed to protect patients at risk of coronavirus (COVID-19) infection. Hoth shall be granted the right for receiving single digit royalties from the sale of any products developed, with the right to acquire up to a 30% equity interest in HaloVax. [1] [2]

In April 2020, HaloVax, signed a Sponsored Research Agreement with the Vaccine and Immunotherapy Center (VIC) of the Massachusetts General Hospital (MGH), for the co-development of a Self-Assembling Vaccine designed to protect patients at risk of novel coronavirus (COVID-19) infection. The agreement intends to boost candidate development and animal model testing of the vaccine. [2]

In April 2020, Voltron Therapeutics entered into a a Sponsored Research Agreement with the Vaccine and Immunotherapy Center (VIC) of the Massachusetts General Hospital (MGH). The goal of the collaboration is to co-develop a new vaccine designed to protect patients at risk of novel coronavirus (COVID-19) infection, leveraging the Self-Assembling Vaccine (SAV) platform developed by the VIC and licensed exclusively to Voltron [3]

Key Development Milestones

In February 2021, Voltron Therapeutics announced that it has initiated second set of preclinical animal testing Self-Assembling Vaccine (SAV) against COVID-2019 infections. These studies will investigate an updated construct, on the basis of the previous testings, so as to ascertain an optimum balance of immune responses to prevent COVID-2019 infections [4] .

In July 2020, Voltron Therapeutics announced that HaloVax initiated preclinical animal testing Self-Assembling Vaccine (SAV) against COVID-2019 infections. Proof-of-concept mouse model data supported an immune response is achieved after inoculation. Voltron plans to take two different vaccines, with differing sets of targets into preclinical testing, to identify the best balance of immune responses for prevention of this pandemic pathogen [5] .

In April 2020, Hoth Therapeutics announced its intention to initiate clinical trials for COVID-19 vaccine.

In April 2020, Hoth Therapeutics announced the selection of two lead vaccine candidates for animal testing [6] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class COVID-19 vaccines, Peptide 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 - - Preclinical USA Parenteral / unspecified HaloVax, Massachusetts General Hospital 03 Jun 2020
COVID 2019 infections - Prevention Preclinical USA Parenteral / unspecified HaloVax, Massachusetts General Hospital 03 Jun 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Massachusetts General Hospital Originator USA
HaloVax Originator USA
HaloVax Owner USA
Massachusetts General Hospital Owner USA
Hoth Therapeutics Collaborator USA
Voltron Therapeutics Collaborator USA

Future Events

Expected Date Event Type Description Updated
31 Dec 2021 Trial Update Hoth Therapeutics announces intention to complete IND-enabling studies in 2021 [7] 17 Jun 2021
31 Mar 2021 Trial Update Halovax and Massachusetts General Hospital plans trial in humans for COVID-19 infections in late 2020 or early 2021 [8] 03 Jul 2020
30 Sep 2020 Trial Update Voltron Therapeutics and Massachusetts General Hospital plans to enter into animal testing this quarter [8] 13 Jul 2020
02 May 2020 Trial Update HaloVax and Massachusetts General Hospital plan preclinical development in COVID-2019 infections by May 2020 [2] 07 Jun 2020

Development History

Event Date Update Type Comment
17 Jun 2021 Trial Update Hoth Therapeutics announces intention to complete IND-enabling studies in 2021 [7] Updated 17 Jun 2021
09 Feb 2021 Trial Update Voltron Therapeutics initiates preclinical studies for COVID-2019 infections (Prevention) in USA (Parenteral) [4] Updated 11 Feb 2021
09 Feb 2021 Trial Update Voltron Therapeutics initiates preclinical studies for COVID-2019 infections in USA (Parenteral) [4] Updated 11 Feb 2021
08 Jul 2020 Trial Update HaloVax initiates preclinical animal testing for COVID-19 infections in USA [5] Updated 13 Jul 2020
09 Jun 2020 Trial Update Voltron Therapeutics and Massachusetts General Hospital plans to enter into animal testing this quarter [8] Updated 13 Jul 2020
09 Jun 2020 Trial Update Halovax and Massachusetts General Hospital plans trial in humans for COVID-19 infections in late 2020 or early 2021 [8] Updated 03 Jul 2020
03 Jun 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) Updated 07 Jun 2020
03 Jun 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (Parenteral) Updated 07 Jun 2020
02 Apr 2020 Trial Update HaloVax and Massachusetts General Hospital plan preclinical development in COVID-2019 infections by May 2020 [2] Updated 07 Jun 2020
02 Apr 2020 Licensing Status Voltron Therapeutics signs sponsored research agreement with Massachusetts General Hospital to develop vaccine for COVID-2019 infections [3] Updated 08 Apr 2020
02 Apr 2020 Licensing Status HaloVax signs sponsored research agreement with Massachusetts General Hospital to develop vaccine for COVID-2019 infections [2] Updated 07 Apr 2020
24 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (Parenteral) Updated 07 Apr 2020
24 Mar 2020 Trial Update HaloVax plans a preclinical trial for COVID-19 infections Updated 07 Apr 2020
23 Mar 2020 Licensing Status HaloVax in-licenses self-assembling vaccine (SAV) platform from Massachusetts General Hospital [1] [2] Updated 07 Apr 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (Parenteral) Updated 07 Apr 2020

References

  1. HaloVax(Tm) Announces Agreement with Hoth Therapeutics to Joint Develop a Self-Assembling Vaccine (SAV) to Protect Patients at Risk of Coronavirus (COVID-19) Infection.

    Media Release
  2. Hoth Update on HaloVax Partnership Vaccine to Fight COVID-19 with Sponsored Research Agreement with the Vaccine and Immunotherapy Center (VIC) of the Massachusetts General Hospital (MGH).

    Media Release
  3. Voltron Therapeutics, Inc. Enters into Sponsored Research Agreement with The Vaccine & Immunotherapy Center at the Massachusetts General Hospital to Develop Potential COVID-19 Vaccine.

    Media Release
  4. Voltron Therapeutics, Inc. Initiates Additional Animal Testing of Self-Assembling Vaccine in Fight Against COVID-19.

    Media Release
  5. Voltron Therapeutics, Inc. Initiates Animal Testing of Self-Assembling Vaccine in Fight Against COVID-19.

    Media Release
  6. Hoth Therapeutics, Inc., Voltron Therapeutics, Inc., & HaloVax Announce Selection of the First of Two Sets of Virus Targeting Peptides for Animal Testing in the Development of a COVID-19 Vaccine.

    Media Release
  7. HOTH Therapeutics SEC Report 2021. Internet-Doc 2021;.

    Available from: URL: https://www.sec.gov/Archives/edgar/data/1711786/000121390021015764/f10k2020_hoththerapeuticsinc.htm
  8. Voltron Therapeutics, Inc. Enters into Sponsored Research Agreement with The Vaccine & Immunotherapy Center at the Massachusetts General Hospital to Advance the Development of a Personalized Cancer Vaccine.

    Media Release
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