Heat Biologics Highlights Importance of T cell Immunity to Prevent COVID-19

White paper highlights potential of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines

DURHAM, NC / ACCESSWIRE / August 5, 2020 / 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 product candidate, today highlighted the importance of T cell immunity in preventing COVID-19 in a white paper released today. Heat's COVID-19 vaccine is being designed to generate robust T cell immunity against SARS-CoV-2, the virus responsible for COVID-19. To read the full white paper, please visit: www.heatbio.com/product-pipeline/scientific-publications.

Key highlights of the white paper include:

• Published studies evaluating patients that have recovered from SARS-CoV-2 infection demonstrate that antibody responses to the virus are fleeting, suggesting that current vaccine approaches that generate a predominantly antibody response may fall short in generating a durable and protective immune response
• Studies from the current COVID-19 pandemic and past studies from patients recovered from the related SARS and MERS outbreak demonstrate the reliance on T cell responses, where CD4 T cells are often required to generate effective antibody responses, and "killer" CD8 T cells may be required to destroy virus infected cells before the virus can replicate
• An ideal vaccine against SARS-Cov-2 should activate multiple arms of the immune system, including innate, humoral (antibodies), and cellular immunity (T cells)
• Heat's COVID-19 vaccine is designed to drive T cell immunity, while also activating antibody responses and innate immunity, which may complement conventional COVID-19 vaccines in combination approaches by enhancing T cell immunity, while contributing to innate immunity and antibody generation, especially in the more vulnerable aged population and/or those with comorbidities

Jeff Wolf, CEO of Heat Biologics, commented, "Our COVID-19 vaccine platform is designed to drive predominantly T cell immunity-in contrast to most of the conventional approaches in clinical development, which focus on antibody immunity. We are designing our vaccine to be used as either a standalone vaccine, or as a prime and boost combination with other vaccines under development, to drive robust T cell immunity and bolster antibody responses, especially in high-risk populations with a compromised immune response. Our confidence is further bolstered by the latest pre-clinical studies demonstrating immunogenicity proof-of-concept. We look forward to advancing our unique vaccine towards human clinical trials."

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. 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.

For more information, please visit: www.heatbio.com, and also follow us on Twitter.

Forward Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements the potential of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines, the vaccine platform being used either standalone, or as a prime and boost combination with other vaccines under development, to drive robust T cell immunity and bolster antibody responses, especially in high-risk populations with a compromised immune response, advancing Heat's unique vaccine towards human clinical trials and Heat's COVID-19 vaccine enhancing T cell immunity, while contributing significantly to innate immunity and antibody generation, especially in the more vulnerable aged population and/or those with comorbidities. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines, the ability to use the vaccine platform either standalone, or as a prime and boost combination with other vaccines under development, in order to drive robust T cell immunity and bolster antibody responses, especially in high-risk populations with a compromised immune response, the ability to advance the vaccine toward clinical trials, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop an effective proprietary COVID-19 vaccine, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

Media and Investor Relations Contact

David Waldman
+1 919 289 4017
investorrelations@heatbio.com

SOURCE: Heat Biologics, Inc.

Released August 5, 2020