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DURHAM, N.C., Feb. 25, 2016 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), an immuno-oncology aggregation developing atypical therapies that actuate a patient’s allowed arrangement adjoin cancer, appear that the aggregation will no best accept new patients in its Phase 2 monotherapy balloon arm evaluating HS-410 abandoned for the analysis of non-muscle invasive float blight (NMIBC).  Heat added the monotherapy balloon arm in acknowledgment to the alternate all-around curtailment of accepted of affliction Bacillus Calmette-Guérin (BCG) in aboriginal 2015.  The curtailment has back again been bound and as such, Heat will no best accept new patients in this balloon arm based on discussions with the U.S. Food and Drug Administration (FDA).  The accommodation does not chronicle to apropos apropos the assurance contour of HS-410.  The 16 patients currently enrolled, out of the advancing 25 patients, can abide accepting HS-410 monotherapy per the abstraction protocol.  Heat anticipates advertisement topline 6-month abstracts from these 16 patients in the fourth division of 2016, ancillary with advertisement abstracts from the company’s BCG aggregate cohorts. 

This accommodation does not appulse the three added randomized Phase 2 balloon accoutrements evaluating HS-410 in aggregate with BCG for the analysis of NMIBC.  As ahead announced, Heat completed acceptance of the 75 patients for these three aggregate balloon accoutrements in October 2015 and continues to apprehend to abode one-year topline efficacy, immune-response and assurance abstracts in the fourth division of 2016.

About HS-410 (vesigenurtacel-L)

HS-410 is an investigational artefact applicant for NMIBC based on Heat’s proprietary ImPACT immunotherapy platform, advised to accomplish CD8 “killer” T beef that advance blight cells.  HS-410 is currently actuality evaluated in a Phase 2, placebo-controlled NMIBC balloon at assorted centers and has been accepted U.S. FDA Fast Track Designation for the analysis of NMIBC.

About Heat Biologics, Inc.

Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology aggregation developing atypical therapies that actuate a patient’s allowed arrangement adjoin cancer.  Heat’s awful specific T cell-stimulating belvedere technologies, ImPACT and ComPACT, anatomy the base of its artefact candidates.  These platforms, in aggregate with added therapies, such as checkpoint inhibitors, are advised to abode three audible but accessory mechanisms of action: able-bodied activation of CD8 “killer” T beef (one of the animal allowed system’s best almighty weapons adjoin cancer); changeabout of tumor-induced allowed suppression; and T corpuscle co-stimulation to added enhance patients’ allowed response.  Currently, Heat is administering a Phase 2 balloon with its HS-410 (vesigenurtacel-L) in patients with non-muscle invasive float blight (NMIBC) and a Phase 1b balloon with its HS-110 (viagenpumatucel-L) in aggregate with an anti-PD-1 checkpoint inhibitor to amusement patients with non-small corpuscle lung blight (NSCLC).  For added information, amuse appointment www.heatbio.com.

Forward Looking Statements This columnist absolution includes advanced statements on our accepted expectations and projections about approaching events. In some cases, advanced statements can be articular by analogue such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and agnate expressions.  These statements are based aloft accepted beliefs, expectations and assumptions and accommodate statements apropos the 16 patients continuing to accept HS-410 monotherapy, the advancing advertisement of topline 6-month abstracts from these 16 patients in the fourth division of 2016 and the accepted advertisement of one-year topline efficacy.  These statements are accountable to a cardinal of risks and uncertainties, abounding of which are difficult to predict, including the adeptness of Heat’s ImPACT and ComPACT therapies to accomplish as designed, the adeptness to accept patients and complete the analytic trials on time, the added factors declared in our anniversary abode on Anatomy 10-K for the year concluded December 31, 2015 and Heat’s added filings with the SEC.  The advice in this absolution is provided alone as of the date of this release, and we undertake no obligation to amend any advanced statements independent in this absolution based on new information, approaching events, or otherwise, except as appropriate by law.

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