Heat Biologics reports 'positive' interim Phase 2 results from HS-110 trial
Heat Biologics announced the latest results of its ongoing Phase 2 clinical trial of HS-110 in combination with Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor, nivolumab, for the treatment of non-small cell lung cancer, or NSCLC. Fifteen patients have completed the HS-110/nivolumab combination treatment to-date and 12 of these 15 patients were evaluable for ELISPOT analysis. Researchers reported a strong correlation between T cell activation, tumor reductions and increased overall survival in these 12 patients. These data reinforce preliminary results seen in the first eight patients as reported last December at the International Association for the Study of Lung Cancer Annual Meeting. Researchers reported continued indications that patients are mounting a vaccine-mediated immune response to the vaccine lysate, as well as to peptides derived from cancer-specific antigens in their peripheral blood cells via ELISPOT analysis. ELISPOT analysis is the most widely used method for monitoring cellular immune responses in humans. This suggests that the HS-110 vaccine is making a measurable contribution to the desired cancer-specific immune response. Of the 15 patients who have completed the HS-110/nivolumab combination treatment to-date, 12 were evaluable for ELISPOT analysis. Six of the 12 evaluable patients met the criteria for a positive ELISPOT response to vaccine lysate, and 5 of these 6 patients experienced tumor reductions and increased overall survival. All 5 patients who exhibited a clinical response also saw an immune response to HS-110. Of the 6 patients who did not respond by ELISPOT analysis, 5 patients saw tumor progression and 1 patient discontinued treatment due to a non-serious adverse event.