On September 14, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that the company has resumed enrollment in its Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, SEP 14, 2016, View Source [SID:SID1234515136]). The decision to resume trial enrollment was based on the positive data reported in June, including two clinical responses in "cold tumor" patients, and enabled by additional company funding through the exercise of warrants, as reported in the latest company financial and corporate update. Schedule your 30 min Free 1stOncology Demo! "We are pleased to resume enrollment in this trial, especially following the three case studies we reported earlier this year in June, where two out of the three patients showed an increase in CD8+ T cells in biopsy samples after treatment with HS-110 plus nivolumab," stated Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "These early data suggest that HS-110 in combination with nivolumab may improve response rates for patients with ‘cold tumors’ who typically have lower response rates to checkpoint inhibitor monotherapy."
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The anti-PD-1 combination trial is designed to evaluate whether HS-110 expands the proportion of NSCLC patients responsive to PD-1 blockade, particularly in the estimated 50% of patients lacking an anti-tumor immune response. There are currently eight patients enrolled and the company expects to report topline 6-month data for these patients in the fourth quarter of this year. Heat intends to complete enrollment of each of the two 9-patient cohorts consistent with the original design of the trial, with the potential to expand each cohort up to 30 patients. The topline data for additional patients enrolled in the trial are anticipated within the next twelve months.
"It is important to note that the trial is structured as a Phase 1b/Phase 2 with pre-specified thresholds in place to expand the trial to a full Phase 2. We believe that we are close to fulfilling these thresholds given the positive clinical responses we have already reported," added Dr. Schreiber.