T cell driven immune response achieved with just a single dose

Potential to be used in combination with other COVID-19 vaccine approaches

DURHAM, NC, USA I August 13, 2020 I Heat Biologics, Inc. (“Heat”) (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today reported preclinical data for Heat’s gp96-based COVID-19. The data, generated at the University of Miami Miller School of Medicine, shows robust T cell mediated immune response directed against the spike protein of SARS-CoV-2.

Heat Biologics’ COVID-19 vaccine induced the expansion of both “killer” CD8+ T cells that destroy virus infected cells, as well as “helper” CD4+ T cells that assist in producing highly specific antibodies. Both T cell subsets were shown to release cytokines that amplify the anti-viral immune response and, upon vaccination, memory CD8+ T cells migrated to the lungs and airways-the tissue-specific site of interest for SARS-CoV-2 infection. These lung and airway tissue resident memory CD8+ T cells are crucial in mounting an effective response to respiratory viruses.

Natasa Strbo, MD, DSc, Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine and co-developer of Heat’s gp96 platform, commented, “We are highly encouraged by the animal data generated around the COVID-19 vaccine and we look forward to publishing the full details of this study in the coming weeks. Specifically, we noted several important immune responses generated by the vaccine against SARS-CoV-2 after a single injection, including SARS-CoV-2 specific CD8+ and CD4+ T cells in the lungs and airways.”

Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, “We are encouraged by the progress being made by other companies developing vaccines against COVID-19. However, unlike most of these approaches that drive primarily an antibody response, our COVID-19 vaccine is designed to drive predominantly T cell immunity along with antibody responses and innate immunity. As a result, we believe our vaccine has the potential to be used as either a standalone vaccine, or in combination with these other approaches to enhance efficacy. I appreciate the tremendous support of Dr. Strbo and her team at the University of Miami, as well as the team at Heat who have worked around the clock given the urgency of the pandemic. We look forward to providing further updates as soon as possible.”

About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company’s gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, HS-130 in Phase 1, and a COVID-19 vaccine program in preclinical development. In addition, Heat is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 which is enrolling in a Phase 1 trial.

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SOURCE: Heat Biologics