Heat Biologics Presents Immune Data on
its HS-410 Phase 2 Bladder Cancer Trial
at the Genitourinary Cancers Symposium
DURHAM, N.C., Feb. 17, 2017 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”)
(Nasdaq:HTBX), announced 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. 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.
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.
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.
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