Heat Biologics Advances COVID-19 Vaccine Program and Sets Q2 Milestones

North Carolina-based biopharmaceutical company Heat Biologics, Inc. (‘Heat’; NASDAQ: HTBX) has provided an update on the development of its COVID-19 vaccine, which is being developed collaboration with researchers at the University of Miami, and announced key milestones for the second quarter of 2020.

  • Anticipated milestones for the second quarter of 2020 include:
    • “Completion of development of a cell-based vaccine expressing gp96-Ig, OX40L-Ig and SARS-CoV-2 protein S”
    • “Generation of proof-of-concept data demonstrating vaccine immunogenicity in relevant preclinical models”
      • “SARS-CoV-2 protein S specific CD8+ T cells in blood and lungs”
      • “SARS-CoV-2 protein S specific antibodies in serum”
    • “Submission of grant applications to fund and accelerate COVID-19 vaccine development”

Chief Executive Officer of Heat Biologics Mr. Jeff Wolf stated, “We are making progress advancing our COVID-19 vaccine program and remain encouraged by the potential of our platform to provide broad cellular and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses.”

“Specifically, along with our University of Miami collaborators, we are finalizing completion of the vaccine and plan to commence preclinical testing this quarter. These studies will measure the antiviral immune response elicited by SARS-CoV-2 specific antigens in the context of potent immune activators, gp96 and OX40L, in both the blood and lungs of preclinical models. We expect to report our preliminary data shortly thereafter.”

“While we are currently funding vaccine development and preclinical studies, we do not expect to use significant corporate resources to advance our COVID-19 vaccine program. We are applying for several large grants to support clinical development of this program and are engaged in collaboration discussions, which we believe may provide attractive and non-dilutive pathways to help accelerate development of our COVID-19 vaccine,” Mr. Wolf continued.

Heat Biologics’ COVID-19 vaccine has been developed using the company’s proprietary gp96 platform, which harnesses the immune-stimulating power of the heat shock protein gp96 to activate CD8+ T cells with protective anti-viral activity.

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The release of select heat shock proteins from dying cells provides a potent pro-inflammatory signal that can initiate a robust immune response, such as through enhancing the immune-boosting activity of key immune cells known as antigen presenting cells (APCs).

By designing their COVID-19 vaccine to incorporate antigen from the SARS-CoV-2 virus spike (S) protein in conjunction with gp96 and activating antibody targeting the immune-stimulating protein OX40L, Heat Biologics intends to promote both a cellular (T-cell based) and humoral (antibody-based) response against the coronavirus.

This attention to cellular anti-viral immunity is unique from many other vaccines, whose focus is to elicit the production of high levels of neutralizing antibody.

According to Heat Biologics, “new data suggest that both T-cell and antibody are required for effective prophylactic protection against COVID-19,” and their vaccine “is being designed to clear virus infected cells by promoting long-term cellular immunity, which is essential for preventing the spread of re-infection in susceptible individuals such as the elderly and other high-risk patients with relevant comorbidities.”

“Unlike most conventional vaccines that predominantly drive a humoral response, Heat’s COVID-19 vaccine platform drives a prominent cellular immune response via CD8+ T cells, in addition to a humoral immune response via a neutralizing IgG antibody.”

“Notably, it was observed that 30% of confirmed COVID-19 patients in China failed to develop high titers of neutralizing antibodies after COVID-19 infection, suggesting a requirement for cellular immunity for recovery. Heat’s COVID-19 vaccine targets the Spike or S protein, and expresses 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,” Heat Biologics stated in a press release.

According to Heat Biologics, their COVID-19 program is “focused on providing prophylactic protection to elderly patients and those with underlying health conditions, the very group of patients with an increased risk of complications and death from COVID-19 infection.”

The company states that their “gp96 platform has previously undergone rigorous testing in numerous National Institutes of Health (NIH) and U.S. Department of Defense (DOD)-funded mice and primate trials as a vaccine against SIV/HIV, malaria, zika and other infectious diseases.”

“These trials have demonstrated gp96 is a powerful platform with demonstrated antiviral activity in the lungs, as evidenced by a potent immune response and effectiveness in the induction of mucosal immunity in several infectious disease models.”

A vaccine against the SARS-CoV-2 virus is also under development by other companies including Moderna, who recently announced interim data from a phase 1 clinical trial indicating the safety and immunogenicity of its mRNA-based COVID-19 vaccine mRNA-1273.