On February 17, 2017 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), reported that it presented a poster of its immunological data from its 94-patient Phase 2 trial evaluating vesigenurtacel-L (HS-410) either alone or in combination with BCG in patients with non-muscle invasive bladder cancer (NMIBC) at the 2017 Genitourinary (GU) Cancers Symposium (Press release, Heat Biologics, FEB 17, 2017, View Source [SID1234517757]). Researchers reported that HS-410, in combination with BCG, continues to be generally well-tolerated, that HS-410 activates CD8+ T cells and that these immune responders appear to have a lower recurrence rate than non-immune responders. Taken together, these data strengthen support for the vaccine mechanism of action and clinical proof-of-concept of immune activation.
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Patients were also evaluated based on their levels of tumor infiltrating lymphocytes (TIL) at the start of treatment. In the placebo arm, patients with low TIL levels at baseline had a higher incidence of disease recurrence than patients with high TIL levels at baseline. However, in the vaccine-treated group, recurrence levels were essentially the same between the high and low TIL subgroups, at 25% and 29%, respectively. The fact that these two groups of patients saw clinical outcomes that were roughly identical may warrant further evaluation.
"These data continue to support our hypothesized vaccine mechanism of action," said Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. "Furthermore, we believe this vaccine treatment strategy could be evaluated in more advanced bladder patient populations, where immunotherapy has been shown to be effective, but where not all patients respond to therapy, likely due to insufficient T cell activation and proliferation."
As previously reported, vaccine arms did not show a statistical improvement over the placebo arm in the primary endpoint (1-year recurrence free survival). However, in keeping with clinical trial guidance, Heat continues to monitor all patients enrolled in the study for a 2-year duration.
The poster will be uploaded to the publications section of Heat’s corporate website in line with the conference’s embargo policy.