Heat Biologics. To Present At The 2015 AACR Annual Meeting

DURHAM, N.C., April 22, 2015 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced details of its presentation providing an update on immune responder and non-responder phenotypes from the phase I clinical trial of HS-410 in bladder cancer. The poster will be delivered by George Fromm, PhD, Heat Biologics' Associate Director of Research, at the 2015 American Association for Cancer Research Annual Meeting, at the Pennsylvania Convention Center in Philadelphia, April 22 at 8:00 a.m. Eastern.

"Bladder cancer is one of the most expensive cancers to treat on a lifetime basis, because it is highly recurrent, primarily treated surgically, and typically is not lethal," said Dr. Fromm. "Our novel genomic prediction of patient response to our vaccine, combined with baseline TIL and PD-L1 expression, showed unique patterns for responding and non-responding patients. We are hopeful that these advances will allow us to target all sub-types of a particular cancer, leading to maximum clinical response in patients."

Repeat biopsy samples from patients in the phase I study were analyzed histologically and by RNA-sequencing. A responder phenotype suggests that patients with low baseline tumor infiltrating lymphocytes (TIL) and low PD-L1 expression can recruit high numbers of CD8+ TIL following treatment with HS-410. Patients with high baseline tumor infiltrating lymphocytes and high expression of PD-L1 did not respond. The RNA-Seq analysis demonstrates that these patients 'cluster' closely with the majority of bladder cancer patients (datasets utilized from The Cancer Genome Atlas) and with the HS-410 vaccine itself. Unique antigens were also identified in the analysis that are also shared amongst specific 'clusters' of bladder cancer patients.

Using unique biomarker signatures, the genomic prediction of patient response was highly accurate and showed distinct trends for a patient who responded to the Company's treatment. This response was confirmed by histology and gene expression analysis showing significant infiltration of CD8+ cytotoxic T cells in the tumor microenvironment of its responders with no increase in CD4+ Helper T cells.

About Heat Biologics, Inc.

Heat Biologics, Inc. (www.heatbio.com) is a clinical-stage biopharmaceutical company focused on developing its novel, "off-the-shelf" ImPACT therapeutic vaccines to combat a wide range of cancers. Our ImPACT Therapy is designed to deliver live, genetically modified, irradiated human cells which are reprogrammed to "pump out" a broad spectrum of cancer-associated antigens together with a potent immune adjuvant called "gp96" to educate and activate a cancer patient's immune system to recognize and kill cancerous cells. Heat is conducting a Phase 2 trial of its viagenpumatucel-L (HS-110) in patients with non-small cell lung cancer as well as a Phase 2 trial with its vesigenurtacel-L (HS-410) in patients with non-muscle invasive bladder cancer.

Forward Looking Statements

This press release includes forward-looking statements 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 potential for Heat's ImPACT Therapy and the ability to target all sub-types of a particular cancer and provide maximum clinical responses in patients. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability for Heat's ImPACT Therapy to perform as designed and the other factors described in our annual report on Form 10-K for the year ended December 31, 2014 and our other filings with the SEC. The information in this release is provided only as of the date of this release, and we undertake 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: Heat Biologics, Inc. Jeff Wolf Chief Executive Officer 919-240-7133 investorrelations@heatbio.com Investor Relations & Media Inquiries Michael Wood LifeSci Advisors, LLC 646-597-6983 mwood@LifeSciAdvisors.com

Heat Biologics


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