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Coronavirus vaccine - Heat Biologics/University of Miami

Drug Profile

Coronavirus vaccine - Heat Biologics/University of Miami

Alternative Names: COVID-19 vaccine - Heat Biologics

Latest Information Update: 04 May 2020

At a glance

  • Originator Heat Biologics; University of Miami
  • Developer Heat Biologics
  • Class Cell therapies; Gene therapies; 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

  • Preclinical COVID 2019 infections

Most Recent Events

  • 05 Mar 2020 Heat Biologics enters into a research collaboration with University of Miami for the development of coronavirus vaccine
  • 03 Mar 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral)
  • 03 Mar 2020 Preclinical trials in COVID-2019 infections in USA (Parenteral)

Development Overview

Introduction

A cell based coronavirus vaccine is being developed by Heat Biologics in collaboration with University of Miami for the treatment and prevention of COVID-2019 infections using its gp96 vaccine platform. The vaccine expresses the Spike or S protein, gp96 and OX40L, a T cell co-stimulator. OX40L co-stimulation expands CD4+ helper T cells that promote B-cell differentiation and IgG/IgA antibody class switching. The vaccine is designed to clear virus infected cells by promoting long-term cellular immunity, essential for preventing the spread of re-infection in susceptible individuals such as the elderly and other high-risk patients with relevant comorbidities. Preclinical development is underway in the US.

Heat shock protein gp96 is a ubiquitous protein found in all human cells and also known as the immune system's swiss army knife due to its function as a potent immune adjuvant playing the role of molecular warning system to induce immunity against necrotic cells. Heat's proprietary gp96 vaccine platform reprograms live cells to continually secrete antigens of interest bound to the gp96, thus activating a robust T-cell response against those antigens. Heat's gp96 vaccine platform activates CD8 T cells, antigen presenting cells and natural killer cells, and induces mucosal immunity that can provide protection against COVID-19 infections.

Company Agreements

In May 2020, Heat Biologics and Waisman Biomanufacturing entered into a manufacturing agreement to manufacture COVID-19 vaccine. According to the agreement, Waisman will support the manufacturing of COVID-19 vaccine for expected phase I clinical trials. [1]

In March 2020, Heat Biologics entered into a strategic collaboration with the University of Miami Miller School of Medicine to support the development of a vaccine leveraging Heat's proprietary gp96 platform designed to target the SARS-CoV-2 coronavirus that causes COVID-19. Under the terms of the research collaboration, University of Miami will develop and test one or more vaccine constructs utilizing Heat's gp-96 vaccine backbone to express antigens associated with COVID-19. [2]

Key Development Milestones

As of March 2020, preclinical development of the corona virus vaccine is underway in the US [3] .

Patent Information

Heat Biologics announced that it has filed a provisional patent for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes coronavirus disease 2019 (COVID-19) [3] .

Drug Properties & Chemical Synopsis

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

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7 (Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical USA Parenteral / unspecified Heat Biologics 03 Mar 2020
COVID 2019 infections - Prevention Preclinical USA Parenteral / unspecified Heat Biologics 03 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Heat Biologics Originator USA
University of Miami Originator USA
Heat Biologics Owner USA
University of Miami Owner USA

Development History

Event Date Update Type Comment
05 Mar 2020 Licensing Status Heat Biologics enters into a research collaboration with University of Miami for the development of coronavirus vaccine [2] Updated 16 Mar 2020
03 Mar 2020 Patent Information Heat Biologics files a provisional patent application for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes coronavirus disease 2019 (COVID-19) [3] Updated 04 May 2020
03 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [3] Updated 16 Mar 2020
03 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (Parenteral) [3] Updated 16 Mar 2020

References

  1. Heat Biologics Announces Collaboration with Waisman Biomanufacturing to Manufacture COVID-19 Vaccine.

    Media Release
  2. Heat Biologics Announces Research Collaboration with University of Miami to Develop Vaccine Designed to Protect Against COVID-19 Coronavirus.

    Media Release
  3. Heat Biologics Launches Program to Develop Vaccine Designed to Protect Against COVID-19 Coronavirus.

    Media Release
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