Heat Biologics Inc (NASDAQ:HTBX) shares fell 3.69% on Wednesday to $2.87 then an additional 56.10% in after-hours trading to $1.26. Share prices have been trading in a 52-week range of $0.40 to $4.71. The company has a market cap of $63.24 million at 23.88 million shares outstanding.
Heat Biologics Inc is a development-stage company focused on developing allogeneic, off-the-shelf cellular therapeutic vaccines to combat a range of cancers. It is an immuno-oncology company, which focuses on T cell-stimulating platform technologies, such as Immune Pan-Antigen Cytotoxic Therapy or ImPACT and Combination Pan-Antigen Cytotoxic Therapy or ComPACT.
Using its ImPACT platform technology, the Company has developed HS-410 as a product candidate to treat non-muscle invasive bladder cancer, and HS-110, 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. 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 to treat patients with NSCLC.
Heat Biologics Inc presented topline data from its 94-patient Phase II trial evaluating HS-410in combination with standard of care, Bacillus Calmette-Guérin for the treatment of non-muscle invasive bladder cancer, at the Society of Urologic Oncology Annual Meeting in San Antonio. Researchers reported that there were encouraging signs of anti-tumor activity as HS-410 generated a robust antigen-specific immune response to multiple tumor-associated peptides in treated patients, while there were no immune responses of this type in the placebo.
However, investors were disappointed to find out that the responses did not translate into clinical outcomes, and there was no statistically significant difference in the primary endpoint between the vaccine and placebo arms of the trial. For now, Heat Biologics Inc will continue to monitor all patients enrolled in the study for an additional 12 months to better assess the durability of the positive immunological responses and in keeping with clinical trial guidance recently issued by International Bladder Cancer Group recommending a 2-year study duration for NMIBC trials.
The ability of HS-410 to prime T-cells suggests a strong signal that the vaccine is having an impact, as well as an opportunity to improve responses, in this challenging disease,” said study principal investigator Gary Steinberg, M.D.
He explained that NMIBC has historically been difficult to treat and that parts of the clinical trial actually preformed much better than historical results, which is a testament to improvements in standard of care and validates their choice to run a controlled clinical trial.
“We were pleased to see a robust antigen-specific immune response, reinforcing our earlier clinical data,” said Jeff Wolf, CEO of Heat Biologics Inc. “Even though we did not achieve our desired clinical outcomes, we are encouraged by the results and believe this, and other combination therapies, have the potential to improve long-term outcomes. In particular, Heat’s ComPACT technology, combining a therapeutic vaccine with an immune co-stimulator in a single product, was designed to substantially improve immune response durability.
He added that the company is actively pursuing new programs to complement their existing platforms, which they expect to announce in early 2017. He also mentioned that they are looking forward to examining the additional top-line data that will be reported next week for their combination trial of HS-110 in with Bristol-Myers Squibb’s Opdivo.
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