On September 12, 2017 / Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer,reported that it 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 (Press release, Heat Biologics, SEP 12, 2017, View Source [SID1234520481]).
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"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."