Florida Department of Health Awards Three-Year Grant to Develop gp96-based Zika Vaccine

• Grant to fund Dr. Natasa Strbo’s Zika preclinical research at the University of Miami
  

DURHAM, N.C., March 16, 2017 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, announced that Natasa Strbo, M.D., D.Sc., Research Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine, received a three-year $981,901 grant from the Florida Department of Health 2016-17 Zika Research Grant Initiative to further develop and test gp96-based Zika vaccine.  This vaccine is being developed under a collaboration between the University of Miami and Heat’s wholly-owned subsidiary, Zolovax, Inc., which has licensed the patent.

The gp96 Zika vaccine is uniquely focused on stimulating a robust immune response in the placenta which is part of the body’s mucosa system and believed to play a key role in Zika transmission from mother to fetus.  Dr. Strbo’s published previous work testing gp96-based vaccines in non-human primates with SIV (primate HIV), where it reduced transmission rates by 73%, led her to believe the vaccine stimulates a robust immune response in the mucosa to protect the fetus.  The grant is expected to cover the preclinical development of the Zika vaccine, and allow Dr. Strbo to expand her laboratory staff.

“We look forward to utilizing these funds to develop this promising vaccine,” said Dr. Strbo.  “We believe it will activate a Zika-specific immune response in the placenta, the protective barrier between the mother and fetus, which is precisely where it needs to block transmission of the Zika virus.”

“This validation is further evidence that Dr. Strbo is on the right track in targeting Zika with our gp96-based vaccine, and why we are working with the University of Miami to develop it,” said Jeff Wolf, Heat’s Founder and Chief Executive Officer.  “These funds should carry this vital work through much of the preclinical development and move it much closer to trials in patients.”

About Heat Biologics, Inc.
Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing novel therapies that are designed to activate a patient’s immune system against cancer utilizing an engineered form of gp96, a protein that activates the immune system when cells die. Heat’s highly specific T cell-stimulating therapeutic vaccine platform technologies, ImPACT and ComPACT, in combination with other therapies, such as checkpoint inhibitors, are designed to address three distinct but synergistic mechanisms of action: robust activation of CD8+ “killer” T cells (one of the human immune system’s most potent weapons against cancer); reversal of tumor-induced immune suppression; and T cell co-stimulation to further enhance patients’ immune response.  Currently, Heat is conducting a Phase 2 trial with HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC) and a Phase 2 trial with HS-410 (vesigenurtacel-L) in patients with non-muscle invasive bladder cancer (NMIBC).

Heat’s wholly-owned subsidiary, Zolovax, Inc., is developing therapeutic and preventative vaccines to treat infectious diseases based on Heat’s gp96 vaccine technology, with a current focus on the development of a Zika vaccine in conjunction with the University of Miami.

For more information, please visit www.heatbio.com.

Forward Looking Statements
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, expectations and assumptions and include statements regarding the belief that the vaccine will activate a Zika-specific immune response in the placenta, the grant funds carrying this vital work through much of the preclinical development and move it much closer to trials in patients and the potential of Heat’s therapeutic and preventative therapies.  These statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including 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, the company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company’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, the company’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, and its ability to retain its key scientists or management personnel and the other factors described in the company’s annual report on Form 10-K for the year ended December 31, 2015 and other filings with the SEC.  The information in this release is provided only as of the date of this release and the company 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.

Contact:
Jennifer Almond
Investor and Media Relations
919-240-7133
Investorrelations@heatbio.com

Released March 16, 2017