Heat Biologics, Inc. to Present Interim Immune Response Data From Ongoing Phase II Trial With HS-110 in Advanced NSCLC at ASCO

Peripheral Immune Response Observed May Justify Future Combinations With Anti-PD-1/L1 Antibodies

DURHAM, N.C., May 29, 2015 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. ("Heat" or the "Company") (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that a poster highlighting viagenpumatucel-L (HS-110) in combination with low dose cyclophosphamide in advanced non-small cell lung cancer (NSCLC) will be presented at the American Society of Clinical Oncology (ASCO) annual meeting, being held at McCormick Place in Chicago, Illinois, May 29-June 2, 2015. The poster will be presented by Dr. Roger Cohen of the Division of Hematology-Oncology, Perelman School of Medicine at the University of Pennsylvania, and lead Principal Investigator for the trial.

Poster Presentation Details
First Interim Exploratory Analysis Of Immune Response in Patients with Advanced Non-Small Cell Lung Cancer Receiving Viagenpumatucel-L (HS-110) in Combination with Low-Dose Cyclophosphamide in an Ongoing Phase II Trial
Session: Developmental Therapeutics - Immunotherapy
Date: Saturday, May 30
Time: 8am - 11:30am Central Time
Location:  Poster Board 403, S Hall A

The poster highlights that the combination of HS-110 and low-dose cyclophosphamide was well tolerated in the first cohort of patients, with only transient adverse events.  Increased PD-1, Tim-3 and Ki67 were observed on CD8+/CD4+ T cells isolated from peripheral blood over the treatment period, which may indicate T cell activation and proliferation in response to HS-110. If these trends are observed in the full cohort of patients, the data may provide mechanistic evidence of HS-110 and support combination therapy with anti-PD-1/L1 antibodies. Further analysis of immune response will be correlated with clinical response. 

About Viagenpumatucel-L (HS-110)

Viagenpumatucel-L (HS-110) ImPACT-modified cell lines are designed to stimulate a patient's immune system to activate a cytotoxic T cell response against a range of antigens that are known to be expressed by a high proportion of patients with NSCLC. The backbone cell line for HS-110 was selected based on antigenic overlap with patient tumor specimens, including known and unknown antigens. This approach is expected to provide a significant advantage over single antigen approaches by reducing the risk of antigen-loss variants emerging post-treatment and by addressing the underlying genetic and antigenic heterogeneity within tumors. Heat Biologics is in Phase 2 clinical trials using HS 110 for the treatment of NSCLC. For more information reference study protocol NCT02439450 on clinicaltrials.gov.

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 of the data providing mechanistic evidence of HS-110 and support combination therapy with anti-PD-1/L1 antibodies, the expected benefit of the HS-110 approach and the potential for impact of Heat's ImPACT™ Therapy. 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, the ability to timely enroll patients and complete the clinical trial on time, 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.
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Source: Heat Biologics