Heat Biologics (NASDAQ: HTBX) is continuing a pre-market rally, currently up 20% following the company’s announcement that its phase 1b trial evaluating HS-110 in combination with Bristol-Myers Squibb’s (NYSE: BMY) nivolumab (Opdivo®) for the treatment of non-small cell lung cancer (NSCLC) has achieved the efficacy endpoint. Additionally, 5 out of 15 patients treated with the HS-110/nivolumab combination had 20% or greater tumor reduction. Upon review, the Data Monitoring Committee (DMC) determined that the positive safety profile, mechanistic evidence and encouraging signs of synergistic efficacy warranted expansion to a phase 2 trial. “We designed this trial with the Bristol-Myers Squibb Checkmate 057 nivolumab trial in mind, which reported a 19% response rate in a similar patient population. Although this is a small sample size and a non-randomized trial, we believe that this is an encouraging sign that the combination may be more effective than checkpoint therapy alone and could provide therapeutic benefit to a majority of lung cancer patients who do not respond well to checkpoint monotherapy. We remain focused on enrolling new patients to better characterize the objective response rate, durability of the response and associated immune activity,” chief scientific officer and senior vice president of preclinical development Jeff Hutchins, Ph.D. stated in the news release.
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About Heat Biologics, Inc.
Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing novel therapies that are designed to activate a patient’s immune system against cancer utilizing an engineered form of gp96, a protein that activates the immune system when cells die. Heat’s highly specific T cell-stimulating therapeutic vaccine platform technologies, ImPACT and ComPACT, 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 1b trial with HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC) and a phase 2 trial with HS-410 (vesigenurtacel-L) in patients with non-muscle invasive bladder cancer (NMIBC). Heat’s wholly-owned subsidiary, Zolovax, Inc., is developing therapeutic and preventative vaccines to treat infectious diseases based on Heat’s gp96 vaccine technology, with a current focus on the development of a Zika vaccine in conjunction with the University of Miami. For more information, please visit www.heatbio.com.
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