Heat Biologics and OncoSec Present Data at the American Conference for Cancer Research (AACR) Annual Meeting

Preclinical findings demonstrate that intratumoral electroporation activate tumor neoantigen-specific immune responses

DURHAM, N.C., April 18, 2016 (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 preclinical data from its collaboration with OncoSec Medical Incorporated (“OncoSec”) focused on evaluating the combination of immunotherapy platforms were presented yesterday at the American Conference for Cancer Research (AACR) Annual Meeting (www.aacr.org).  

In the poster entitled “In vivo intra-tumoral electroporation of gp96-Ig/Fc-OX40L stimulates CD8⁺ T cell cross-priming to tumor specific neoantigens” (Abstract #567), researchers concluded that combining Heat’s ComPACT vaccine with OncoSec’s intratumoral DNA electroporation delivery platform stimulated an expansion of neoantigen-specific CD8⁺ T cells, leading to a regression in both treated and untreated cancer lesions in two mouse studies (melanoma and colorectal cancer).  Heat and OncoSec announced their collaboration last year to evaluate the preclinical efficacy of delivering Heat’s immunotherapy vaccines via OncoSec’s ImmunoPulse™ platform.

“In this first preclinical study demonstrating the feasibility of electroporating ComPACT DNA plasmids, we saw robust neoantigen T cell response and tumor regression in both treated and untreated tumors, indicating a systemic anti-tumor response that could be reflective of what we might see in metastatic lesions,” said Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer.  “We believe that this approach is promising and that further studies are merited, especially as this combination approach has the potential to stimulate shared and private tumor antigens without introducing the complexities associated with personalized therapies.”

“We are excited by our collaboration with Heat and by these initial findings.  The ability of the tumor’s microenvironment to evade immune recognition and remain non-immunogenic is a significant challenge, which we believe needs to be addressed when designing new immuno-therapies,” added Robert H. Pierce, M.D., OncoSec’s Chief Scientific Officer.  “The initial feasibility data between our two platforms are encouraging and we are currently exploring the potential synergy between our platforms with both ComPACT and interleukin-12 expressing plasmids.”

Copies of the abstract are available and can be viewed online through the AACR website at www.aacr.org. 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 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 an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC).  For more information, please visit www.heatbio.com.

About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies for the treatment of cancer.  The Company's investigational technology, ImmunoPulse™, is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as interleukin-12 (IL-12).  In Phase I and II clinical trials, OncoSec's lead program, ImmunoPulse™ IL-12, demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response.  ImmunoPulse™ IL-12 is currently in clinical development for several indications, including metastatic melanoma and triple-negative breast cancer.  In addition to ImmunoPulse™ IL-12, the Company is also seeking to identify and develop new immune-targeting agents for use with the ImmunoPulse™ platform.  For more information, please visit www.oncosec.com.

Heat Biologics, Inc. Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about Heat’s 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 indication of a systemic anti-tumor response that could be reflective of what might be seen in metastatic lesions, the belief that the approach is promising and that further studies are merited, the potential of the combination approach to stimulate shared and private tumor antigens without introducing the complexities associated with personalized therapies, the belief that the design of new immune-therapies needs to address the tumor microenvironment’s ability to evade immune recognition and remain non-immunogenic, the expectation that any future studies will further explore the synergies between Heat’s and OncoSec’s platforms with both ComPACT and IL-12 expressing plasmids 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, 2015 and our other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K.  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.
                                    
OncoSec Medical Incorporated Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “potential,” “could,” “will,” “believe,” “expect,” "can,” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission.

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Heat Biologics Contact Information:
Jennifer Almond
Investor and Media Relations
919-240-7133
investorrelations@heatbio.com

OncoSec Contact Information:
Mary Marolla
Corporate Communications
855-662-6732
media@oncosec.com

Released April 18, 2016