DURHAM, N.C., Dec. 2, 2014 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced the expansion of its product development team. Three new director-level team members have joined Heat to help execute its Phase 2 strategy and prepare for Phase 3 delivery. The new hires will assume responsibility for Manufacturing, Regulatory Affairs and Quality Assurance, and Clinical Operations under the direction of Dr. Melissa Price, VP of Clinical and Regulatory Affairs.
"Our expanded product development team brings us a wealth of relevant expertise," said Jeff Wolf, CEO of Heat Biologics. "These new team members have broad-based drug development experience that will be very important as we progress our lead products, HS‑110 and HS-410, through Phase 2 trials for non-small cell lung and bladder cancers, respectively."
Damien Hallet joins Heat Biologics as Senior Director of Manufacturing and will assume responsibility for overall manufacturing strategy. Mr. Hallet has more than 14 years of international industry experience in the production of multiple biologic medicinal products. He has an exceptionally broad scientific and technical background as a scientist and group leader in managing various bioprocess development and manufacturing activities. Most recently he was CMC project lead at UCB Celltech. Mr. Hallet holds a Master of Engineering degree in Biochemistry and a Master of Advanced Studies in industrial microbiology from INSA de Toulouse in France.
Maria Oyaski joins Heat as Director of Regulatory Affairs and Quality Assurance, and will be responsible for leading the Company's regulatory strategy and for assuring quality of manufacturing and clinical operations. She brings to the position 14 years of industry experience with over a decade in regulatory affairs for a broad range of medical products, including most recently leading regulatory activities at Argos Therapeutics for complex cellular immunotherapies in oncology. Ms. Oyaski holds Regulatory Affairs Certification (RAC) for both the US and EU. She also holds a Master of Science in Cell and Molecular Biology from the University of Pennsylvania, and a Master of Arts in History and Philosophy of Science from the University of Pittsburgh.
Brandon Early joins Heat as Senior Director of Clinical Affairs and will assume overall responsibility for the execution of the Company's Clinical Strategy. Mr. Early brings to Heat Biologics deep clinical experience in oncology and immunology having led global Oncology programs at INC Research. Mr. Early began his career as a Clinical Research Coordinator at the University of Virginia in the Carter Immunology Center, and Asthma and Allergic Disease Division. He has published his immunology research in several peer-reviewed journals. He holds a Master's degree in Clinical Research from the University of Virginia.
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 is conducting a Phase 2 trial of its viagenpumatucel-L (HS-110) in patients with non-small cell lung cancer as well as a Phase 2 with its vesigenurtacel-L (HS-410) in patients with non-muscle invasive 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 expected contribution of each of the new team members and the potential for Heat's ImPACT Therapy. 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 successfully integrate the new team members and the other factors described in our annual report on Form 10-K for the year ended December 31, 2013 and our 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.