Research scientists from the University of Miami have teamed with North Carolina-based Heat Biologics to develop a vaccine for the coronavirus. Elite immunologists within the South Florida-based university are focusing on the biotech’s gp96 platform designed to target the SARS-CoV-2 coronavirus that causes COVID-19. Previous research hints that Heat’s University of Miami-originated gp96-based vaccines could possibly be utilized to target COVID-19.

What is gp96?

Heat shock protein gp96 is a chaperone protein found in all human cells. It is a potent immune adjuvant that has the role of “molecular warning system,” or more specifically, gp96 has demonstrated clinical ability to induce immunity against antigens from the cell it came from. Gp96 is naturally tethered to the cell and is normally released only during necrosis of cell death.

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 platform was developed by Dr. Eckhard Podack at the University of Miami and has undergone rigorous testing in numerous NIH and DOD-funded mice and primate trials as a vaccine against HIV, malaria, and other infectious diseases. The experimental vaccine has been tested in over 300 patients in numerous NIH and Heat-funded oncology trials. The University of Miami licensed the underlying intellectual property to a Heat Biologics subsidiary.

Who is Heat Biologics?

Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ “Killer” T-cells. The heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company’s first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient’s own T-cells. Heat also has numerous pre-clinical programs at various stages of development.

The Development Effort

Heat’s COVID-19 vaccine will utilize Heat’s gp96 platform to generate open docking sites for the insertion of multiple SARS-CoV-2 antigens. Heat anticipates that its novel approach should activate a potent immune response, without the disadvantages of possible genomic integration of foreign DNA or viral vector instability possible with attenuated viral vaccines. This approach is designed to induce a multi-epitope specific memory CD8 T-cell response that protects against multiple, distinct coronavirus strains across diverse human populations and against potential future mutations of SARS-CoV-2 and another coronavirus.

Heat’s COVID-19 program emerged from the same laboratory that originally developed Heat’s gp96 platform technology, and will be developed at the University of Miami Miller School of Medicine under the direction of Natasa Strbo, M.D., D.Sc., research assistant professor of microbiology and immunology, who has spent many years advancing the gp96 platform as a vaccine against HIV, malaria, zika and other infectious diseases.

Mucosal immunity and airway memory T-cell responses are crucial in the protection against respiratory viruses such as SARS-CoV-2 since these areas are the first to encounter the virus. Importantly, Heat’s gp96-based vaccines have demonstrated effectiveness in the induction of mucosal immunity. Dr. Strbo and her team have developed a gp96 vaccine against SIV (the primate equivalent of HIV) that has been shown to induce a dramatic antigen-specific immune response in the mucous membranes. Treated primates (rhesus macaques) were 73 percent less likely to acquire a particularly virulent form of the SIV virus*. This data supports broader use of the vaccine platform against other viruses attacking the mucosal tissues, such as COVID-19.

Heat Mobilizes Wholly-owned Subsidiary

Zolovax Inc., a wholly-owned subsidiary of Heat Biologics, will focus on the development of the COVID-19 vaccine. Under the terms of the research collaboration, the 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. The underlying intellectual property was licensed to Zolovax.

Lead Research/Investigator

Natasa Strbo, M.D., D.Sc., research assistant professor of microbiology and immunology

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