Heat Biologics (HTBX) Reports 1st Patient Dosed in New Cohort of Expanded Phase 2 Trial of HS-110 in Combination with Merck's (MRK) KEYTRUDA in NSCLC Trial

January 14, 2019 8:15 AM EST
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Heat Biologics, Inc. (NASDAQ: HTBX) today announced that it has dosed its first patient in its Phase 2 clinical trial investigating HS-110 in combination with Merck's (NYSE: MRK) anti-PD1 checkpoint inhibitor, KEYTRUDA (pembrolizumab), in patients with advanced non-small cell lung cancer (NSCLC). This expansion of the Company's Phase 2 trial into first-line maintenance treatment with Keytruda follows positive interim results reported earlier this year on previously treated patients receiving HS-110 in combination with Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab). Heat will continue to dose patients with HS-110 in combination with Opdivo as well.

The Company amended its Phase 2 master protocol to include additional patient cohorts in the front-line maintenance setting for advanced NSCLC. Patients in these cohorts will have received a minimum of 9 weeks of pembrolizumab, with or without chemotherapy, and will begin maintenance treatment receiving HS-110 with pembrolizumab pemetrexed. Patients will be evaluated for objective response rate as well as progression-free and overall survival.

Dr. Daniel Morgensztern, Associate Professor of Washington University in St. Louis and lead investigator for this trial, commented, ''Results from the ongoing Phase 2, multicenter clinical trial combining HS-110 with Bristol-Myers Squibb's checkpoint inhibitor nivolumab (Opdivo), suggest that HS-110 may enhance the efficacy of checkpoint inhibitors in patients with advanced lung cancer. Expanding this trial to include Merck's anti-PD-1 checkpoint inhibitor pembrolizumab (KEYTRUDA) is an important next step in evaluating the broad potential of this platform technology.''

Jeff Wolf, Heat's CEO, further noted, ''The expansion of this trial to include a combination of HS-110 with KEYTRUDA is in line with our strategy to combine our T-cell activation platform with multiple checkpoint inhibitors. We are very excited to begin dosing patients in this cohort.''

New interim data on those patients in this ongoing Phase 2 trial that have been treated with the HS-110 plus nivolumab combination have been selected for oral presentation at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on February 28. To learn more about the trial, visit www.heatbio.com. Additional details can also be found at www.clinicaltrials.gov via NCT02439450.

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