Heat Biologics Resumes Enrollment in its Non-Small Cell Lung Cancer Trial Evaluating HS-110 in Combination with Anti-PD-1 Checkpoint Inhibitor.
HEAT BIOLOGICS, INC. (NASDAQ:HTBX)
Today : Wednesday 14 September 2016
Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, announced 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). 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.
“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.”
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.
About Heat Biologics, Inc.
Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer. Heat’s highly specific T cell-stimulating platform technologies, ImPACT and ComPACT, form the basis of its product candidates. These platforms, in combination with other therapies, such as checkpoint inhibitors, are designed to address three distinct but synergistic mechanisms of action: robust activation of CD8+ “killer” T cells (one of the human immune system’s most potent weapons against cancer); reversal of tumor-induced immune suppression; and T cell co-stimulation to further enhance patients’ immune response. Currently, Heat is conducting a Phase 2 trial with its HS-410 (vesigenurtacel-L) in patients with non-muscle invasive bladder cancer (NMIBC) and a Phase 1b trial with its HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC). For more information, please visit www.heatbio.com.
"The refusal of the real is the number one dogma of our time" Rene Girard
