Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Other Events
Item 8.01. Other Events.
In connection with the planned oral presentation of Heat Biologic’s Inc.’s (the “Company”) new HS-110 interim Phase 2 data at the upcoming 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on February 28, 2019, by the principal investigator for the trial, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, an abstract has been posted on the ASCO-SITC website.
The abstract summarizes interim data from the first two cohorts (A & B) of the Company’s Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo®), in patients with advanced non-small cell lung cancer (NSCLC). Cohort A is comprised of previously-treated patients who have never received checkpoint inhibitor therapy; Cohort B is comprised of patients whose prior treatment does include checkpoint inhibitor therapy followed by disease progression.
Cohort A results are consistent with those reported in early 2018. With a median follow-up of 14.4 months in this cohort, the median overall survival has not yet been reached and 60% of patients remain alive. Protocol-defined subgroup analysis of patients categorized as ‘high’ or ‘low’ TIL (tumor infiltrating lymphocytes), based on levels of CD8+ cells present in the stroma of their tumor tissue at baseline, demonstrate a survival advantage for the ‘low TIL’ group as compared to the ‘high TIL’ group (not reached vs 13.8 months). Survival status was independent of patient PD-L1 expression levels on tumor samples from baseline. Objective Response Rate (ORR), Disease Control Rate (DCR) and Progression-Free Survival (PFS) per RECIST 1.1 are 18.6%, 48.8% and 1.9 months, respectively. The landmark 1 year PFS was 23.9% in Cohort A.
The abstract and presentation also contain the first data ever disclosed for Cohort B, patients whose disease progressed while receiving checkpoint inhibitor therapy at any time prior to study entry. Preliminary results suggest that adding HS-110 to nivolumab can restore responsiveness to checkpoint inhibitors with an investigator-assessed ORR of 22%, a DCR of 50%, and a median Progression-Free Survival of 2.2 months.
In both cohorts, combination with HS-110 and nivolumab was well-tolerated with the most common adverse events (AEs) reported as fatigue (31%), cough and diarrhea (19.7% each).
During the presentation, Dr. Morgensztern plans to discuss the interim results of the trial in greater detail along with a subset of correlative assessments and post-hoc analysis that support the mechanism of action of HS-110. Note that because the trial is still enrolling and new data has emerged since abstract submission in November 2018, Dr. Morgensztern’s presentation and poster will contain updated results which may vary from the original abstract. The complete abstract is available online at: abstracts.asco.org.
About Heat Biologics, Inc. (NASDAQ:HTBX)
Heat Biologics, Inc. is a development-stage company focused on developing allogeneic, off-the-shelf cellular therapeutic vaccines to combat a range of cancers. The Company is an immuno-oncology company, which focuses on T cell-stimulating platform technologies, such as Immune Pan-Antigen Cytotoxic Therapy (ImPACT) and Combination Pan-Antigen Cytotoxic Therapy (ComPACT). Using its ImPACT platform technology, the Company has developed HS-410 (vesigenurtacel-L) as a product candidate to treat non-muscle invasive bladder cancer (NMIBC), and HS-110 (viagenpumatucel-L), which is intended for use in combination with an anti-PD-1 checkpoint inhibitor, as a potential treatment for patients with non-small cell lung cancer (NSCLC). Using its ComPACT platform technology, it has developed HS-120 as a potential treatment for NSCLC. It is conducting a Phase II trial of HS-410 in patients with NMIBC, and a Phase Ib trial of HS-110, in combination with nivolumab (Opdivo) to treat patients with NSCLC.
