Heat Biologics Granted Type C Meeting with FDA to Discuss Registrational Pathway for HS-110 in Combination with Opdivo(R) as a Treatment for Non-Small Cell Lung Cancer
DURHAM, NC / ACCESSWIRE / September 12, 2017 / Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient's immune system against cancer, has been granted a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the registrational pathway for our non-small cell lung cancer (NSCLC) trial with HS-110 in combination with Bristol Myers-Squibb's Opdivo® based upon our maturing Phase 2 data.
"We are looking forward to discussing our proposed HS-110 registrational pathway and development plan for the treatment of advanced NSCLC," said Jeff Wolf, CEO of Heat. "We are encouraged by the positive safety and efficacy signals that have been previously reported, which support the hypothesis that tumor-specific T-cell activation enhances the clinical activity of checkpoint inhibitor therapy. We are adapting to the changing landscape of cancer immunotherapy by incorporating novel combinations, and very much look forward to progressing our study."
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer using of CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors "hot" and be administered in combination with checkpoint inhibitor therapies and other immuno-modulators to increase their effectiveness. We are currently enrolling patients in our Phase 2 clinical trial for non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®). We also have numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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 our plans for our study and prospects for our therapies, including their therapeutic benefits. These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of Heat's ImPACT therapy to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel, its ability to successfully integrate Pelican and the other factors described in Heat's most recent annual report on Form 10-K and other filings with the SEC. The information in this release is provided only as of the date of this release and the company undertakes 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.
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Released September 12, 2017