CHAPEL HILL, NC--(Marketwired - December 30, 2013) - Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that its Phase 1/2 Study of HS-410 in bladder cancer patients is open for enrollment. HS-410 is a biologic product candidate designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer.
"We are excited to open enrollment on schedule with our Phase 1/2 study of HS-410 in patients with bladder cancer," said Jeff Wolf, CEO of Heat. "This is a significant milestone for the Company as we remain focused on advancing Heat's proprietary ImPACT therapy into late-stage clinical studies."
The multi-center Phase 1/2 study will enroll approximately 93 patients and is designed to determine whether vaccination with HS-410 after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG) extends the time to disease recurrence compared to placebo. The trial will also test the safety of HS-410 in bladder cancer patients. The Company expects to begin dosing patients in January 2014.
Mark P. Schoenberg, MD, Bernard L. Schwartz Distinguished Professor of Urologic Oncology Director, Division of Urologic Oncology, Johns Hopkins Medical Institutions and an advisor to Heat worked with the Company to design the Protocol of the Phase 1/2 bladder cancer study.
Heat's proprietary Immune Pan Antigen Cytotoxic Therapy ("ImPACT") reprograms live cancer cells from a single tumor source to continually secrete gp96, a chaperone protein found in all human cells. In turn, gp96 chaperones tumor antigens to T-cells to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient's cancer. Heat's ImPACT technology holds promise for treating a wide variety of different cancers.
According to the American Cancer Society, in 2012, there were 73,000 new cases of bladder cancer reported and 15,000 deaths from the disease in the U.S. alone. More than 500,000 people in the U.S. have been treated for bladder cancer. Importantly, the U.S. Food and Drug Administration "FDA" has not approved any new drugs to treat bladder cancer in more than 25 years. Heat's HS-410 represents a viable opportunity to address a significant unmet medical need.
About HS-410 for the Treatment of Advanced Bladder Cancer
HS-410 is a biologic product candidate which consists of a bladder cancer cell line that has been genetically modified using Heat's ImPACT technology platform to secrete a wide range of bladder cancer antigens bound to a gp96 adjuvant and is designed to activate a T-cell mediated pan-antigen immune response against the patient's bladder cancer.
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's HS-110 will be entering Phase 2 trials against non-small cell lung cancer and its HS-410 is entering Phase 1/2 clinical trials against 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 expected timing of patient dosing. 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 ability to enroll patients as planned. 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.