CHAPEL HILL, NC--(Marketwired - Oct 1, 2013) - Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, today announced that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for its second product candidate, HS-410, which will be evaluated in bladder cancer.
The Company also named Melissa Price, Ph.D., as Vice President, Clinical and Regulatory Affairs. Dr. Price will be responsible for the implementation of Heat's HS-410 bladder cancer program, as well as all of the Company's clinical studies. Dr. Price will also direct the company's regulatory strategy.
"We are pleased to welcome Melissa to the team," said Jeff Wolf, Chief Executive Officer of Heat Biologics. "Melissa's oncology experience will serve us well as we continue to progress our two lead product candidates through clinical trials in non-small cell lung and bladder cancers. With the filing of the IND for our second product candidate, our clinical development activities are increasing and we are pleased to have Melissa spearheading the effort."
Dr. Price brings to Heat Biologics significant experience in oncology drug development. Most recently, she was at global contract research organization INC Research, where she was Vice President, Global FSP Solutions. Previously, she was a Senior Director, Drug Development Partnerships at Novaquest, a Quintiles Company, where she provided scientific, business and financial strategy for external oncology trials and partnerships. She began her drug development career at Attenuon, an oncology focused biotechnology company, where she planned and managed international oncology clinical trials. Dr. Price's work has been published in numerous scientific journals. Dr. Price holds a Ph.D. in Organic Chemistry from Yale University.
"I am excited to be joining the Company, particularly at this time, as its development efforts now include two product candidates in or about to enter clinical trials," said Dr. Price. "Heat Biologics' ImPACT Therapy holds great potential to treat cancer patients in a very unique way and I look forward to helping the Company advance its technology in order to serve patients suffering from cancer."
About Heat Biologics:
Heat Biologics (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 proprietary ImPACT Therapy is being 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 shock protein gp-96 is a chaperone protein found in all human cells. Heat's lead compound, HS-110, will be entering Phase 2 trials against non-small cell lung cancer and its second product candidate, HS-410 will be entering Phase 1/2 clinical trials against bladder cancer.
This 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 Heat's continued clinical trials and its goals. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the expected contribution Dr Price and the potential for Heat's ImPACT Therapy. 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.