Heat Biologics Inc (NASDAQ:HTBX) Posts Positive Report On Primary Objective With Positive Safety Data

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Heat Biologics Inc (NASDAQ:HTBX) a pioneer in the advancement of gp96-based immunotherapies intended to activate a subject’s immune system to combat cancer, posted topline survival and response data in the underway Phase Ib trial assessing HS-110, together with nivolumab, for the cure of NSCLC, at annual meeting of the “International Association for the Study of Lung Cancer.”

The highlights

In an oral presentation, Daniel Morgensztern, MD, the principal investigator, posted that one-year data from the initial eight trial subjects represented that the nivolumab/ HS-110 combination was well-tolerated, and showed a safety profile steady with single agent nivolumab. Moreover, there were no extra toxicities noted in nivolumab/ HS-110 combination versus prevailing data on nivolumab alone. HS-110 released a strong antigen-specific protected response in numerous patients, steady with the action mechanism noted in other HS-110 studies.

Additionally, the subjects who responded best to this combination therapy had improved objective response rate and longer overall survival compared to the non-immune responders, although they boasted the same baseline immune activity. Immune responders in the trial witnessed a ORR of 50%, while non-immune responders witnessed ORR of 0%. This is vital, as checkpoint inhibitors have been revealed, autonomously, to be effective in tumors with pre-existing, TIL. As such, there prevails an acute need to report the large percentage of non-responders with poor TIL tumors.

Moreover, the immune responders showed a better median OS compared to non-immune responders. The 1-year OS is presently 50% and 25% for the responders and the non-responders, respectively. Ultimately, immune responders also witnessed an improved median OS at 12.7 months, compared to median OS at 7.1 months for the non-immune responders. Researchers decided that immune response may associate with clinical effectiveness and HS-110 may show synergistic activity.

Dr. Morgensztern added that they are thrilled by the report generated in the study. They were captivated by the capability of HS-110 to stimulate a “CD8+ T” cell immune response.


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