Results of Heat Biologics' HS-410 Phase 1 Safety Trial in Non-Muscle Invasive Bladder Cancer to be Presented at SITC Annual Meeting

DURHAM, N.C., Nov. 3, 2015 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient's immune system against cancer, announced that new data from its Phase 1 safety trial of HS-410 (vesigenurtacel-L), after standard of care Bacillus Calmette-Guérin (BCG), for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC) will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 30th Anniversary Annual Meeting & Associated Programs. SITC is being held November 4-8, 2015 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland. The poster will be presented by Gary D. Steinberg, M.D., Professor of Surgery and Director, Urologic Oncology, at The University of Chicago Medicine, and lead study investigator for the trial.  

Presentation details include:

Title: Phase 1 Study of Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Treated with Vesigenurtacel-L (HS-410) After Bacillus Calmette-Guérin (BCG)

Poster Number: 469

Time: Friday, November 6 at 12:30 p.m. to 2:00 p.m. Eastern Time

In addition, Heat will be presenting a development update on the ComPACT platform with data in multiple tumor models.  The poster entitled "Locally Secreted Fc-OX40L is Superior to Systemic, Antibody Mediated, OX40 Costimulation for Combination Immunotherapy" (#388) will be presented on Saturday, November 7 at 12:30 p.m. to 2:00 p.m. Eastern Time. 

About HS-410 (vesigenurtacel-L)

HS-410 is an investigational product candidate for NMIBC based on Heat's proprietary ImPACT™ immunotherapy platform, designed to generate CD8+ "killer" T cells that attack cancer cells. HS-410 is currently in an ongoing Phase 2, placebo-controlled, 100-patient NMIBC trial at multiple centers and has been granted U.S. FDA Fast Track Designation for the treatment of NMIBC. Topline data from the Phase 2 trial is anticipated in the fourth quarter of 2016.

About the Phase 1 NMIBC Trial

According to the American Cancer Society, bladder cancer is the fifth most common cancer in the U.S., with approximately 75,000 new cases and 16,000 deaths in 2015. About 75% of the newly diagnosed patients have NMIBC.  A key issue for bladder cancer is the high rate of recurrence, for which limited treatment options are available beyond complete bladder removal.

The Phase 1 open-label, multicenter safety trial tested HS-410, after standard of care BCG, in 10 patients with NMIBC.  Patients received the standard BCG treatment for 3-6 weeks, followed by weekly intradermal injections of HS-410 for 12 weeks and subsequent monthly HS-410 injections for 3 months. All baseline immunological measurements in blood were conducted after BCG induction therapy. The patients were followed for one year.

About Heat Biologics, Inc. 

Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing novel therapies that activate a patient's immune system against cancer. Heat's highly specific T cell-stimulating 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 a PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC).  

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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 expected timing of the one year safety and immune response data from the Phase 1 trial evaluating HS-410, the anticipated timing of topline data from the Phase 2 trial in the fourth quarter of 2016 and the potential of Heat's ImPACT and ComPACT therapies. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's ImPACT and ComPACT therapies to perform as designed, the ability to enroll patients and complete the clinical trials on time, the other factors described in our annual report on Form 10-K for the year ended December 31, 2014 and Heat's 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.
         Jennifer Almond
         Investor and Media Relations

Heat Biologics

Source: Heat Biologics