Heat Biologics Presents ComPACT Preclinical Data at the Society for Immunotherapy of Cancer Annual Meeting

Enhanced Tumor Rejection in Colorectal Cancer Mouse Model

Combined Synergistically with PD1 and PD-L1 Checkpoint Inhibitors

DURHAM, N.C., Nov. 14, 2016 -- Heat Biologics, Inc. (Nasdaq:HTBX), a leader in the development of gp96-based immunotherapies that are designed to activate a patient’s immune system to fight cancer, announced that preclinical data from its ComPACT platform, a single product that combines Heat’s ImPACT therapeutic vaccine with an immune co-stimulatory molecule, was presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. In the poster, “Gp96-Ig/Costimulator (OX40L, ICOSL, or 4-IBBL) Combination Vaccine Improves T-cell Priming and Enhances Immunity, Memory and Tumor Elimination,” researchers assessed ComPACT/OX40L in a third preclinical mouse tumor model: colorectal cancer (MC38). ComPACT/OX40L amplified antigen-specific CD8+ T cells and memory precursor effector cells (MPECs). It also blocked tumor growth, and increased both tumor rejection and animal survival, generating better results than an OX40 antibody, and without the broad systemic inflammation typically seen with OX40 antibody therapy. Furthermore, ComPACT/OX40L, combined with either PD1 or PD-L1 blocking antibodies, produced even greater antitumor immunity than either compound alone.

The researchers concluded that ComPACT synergizes well with checkpoint inhibitors, which could provide an effective cancer treatment approach in humans.

These studies expand on previous ComPACT studies, which demonstrated anti-tumor efficacy of ComPACT/OX40L in two mouse models: colon cancer and melanoma, where it was attributed to amplified antigen-specific CD8+ T cell expansion (Fromm et. al. Cancer Immunology Research. 2016).  

“These data provide a compelling mechanistic rationale for combinations between ComPACT vaccines and PD-1/L1 blockade,” said Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer, and a study author. “The combination significantly increased the frequency of tumor-antigen specific CD8+ T cells, and increased the fraction of those cells that are most likely to become long-lived memory cells capable of providing durable tumor immunity.” 

The poster is available in the Publications section of Heat’s corporate website.

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, form the basis of its product candidates. These platforms, 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 its HS-410 (vesigenurtacel-L) in patients with non-muscle invasive bladder cancer (NMIBC) and a Phase 1b trial with its HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC).

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. The Zolovax patent portfolio also includes gp96 vaccines targeting West Nile virus, Dengue and yellow fever among others.

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 ComPACT providing an effective cancer treatment approach in humans, potential of Heat’s ImPACT and ComPACT therapies and its Zika vaccine.  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 ImPACT and ComPACT therapies and any gp96 vaccine developed to treat Zika 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.

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