Heat Biologics, Inc. (NASDAQ: HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines, announced today that the Company has formally launched a program within its wholly-owned subsidiary, Zolovax, Inc., to develop a vaccine using its immune activating gp96 vaccine platform for treating or preventing infection from the SARS-CoV-2 coronavirus that causes COVID-19. The Company also 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).

Heat shock protein gp96 is a versatile and ubiquitous protein found in all human cells. It has been called the immune system's swiss army knife* due to its function as a potent immune adjuvant that has the role of "molecular warning system" to induce immunity against necrotic cells. gp96 is naturally tethered to the cell and is normally released only during necrosis or 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 has 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, and has been tested in over 250 patients in multiple NIH and Heat-funded oncology trials.

Jeff Wolf, CEO of Heat, commented, "gp96 is a powerful vaccine platform that has been shown to induce a potent immune response and effectiveness in the induction of mucosal immunity in several infectious disease models. We believe this platform has the potential to provide broad protection against COVID-19, and possible future mutations of COVID-19 or other coronaviruses. We look forward to providing further updates on our progress as developments unfold."

*Schild, H., & Rammensee, H.G., gp96 - The Immune System' s Swiss Army Knife. Nature Immunology 2000 Aug;1(2):100-1.