Heat Biologics Presents Immune Data on its HS-410 Phase 2 Bladder Cancer Trial at the Genitourinary Cancers Symposium
February 17 2017 - 7:00AM
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.
Heat’s highly specific T cell-stimulating therapeutic vaccine
platform technologies, ImPACT and ComPACT, form the basis of its
product candidates. These platforms, in combination with other
therapies, such as checkpoint inhibitors, are designed to address
three distinct but synergistic mechanisms of action: robust
activation of CD8+ “killer” T cells (one of the human immune
system’s most potent weapons against cancer); reversal of
tumor-induced immune suppression; and T cell co-stimulation to
further enhance patients’ immune response. Currently, Heat is
conducting a Phase 1b trial with HS-110 (viagenpumatucel-L) in
combination with an anti-PD-1 checkpoint inhibitor to treat
patients with non-small cell lung cancer (NSCLC) and a Phase 2
trial with HS-410 (vesigenurtacel-L) in patients with non-muscle
invasive bladder cancer (NMIBC).
Heat’s wholly-owned subsidiary, Zolovax, Inc.,
is developing therapeutic and preventative vaccines to treat
infectious diseases based on Heat’s gp96 vaccine technology, with a
current focus on the development of a Zika vaccine in conjunction
with the University of Miami.
For more information, please visit
www.heatbio.com.
Forward Looking Statements This
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 on
our current expectations and projections about future events.
In some cases, forward-looking statements can be identified by
terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are
based upon current beliefs, expectations and assumptions and
include statements regarding the data continuing to support Heat’s
hypothesized vaccine mechanism of action, Heat’s belief that
the 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 and the
potential of Heat’s ImPACT and ComPACT therapies. These
statements are based on management’s expectations and assumptions
as of the date of this press release and are subject to a number of
risks and uncertainties, many of which are difficult to predict
that could cause actual results to differ materially from current
expectations and assumptions from those set forth or implied by any
forward-looking statements, including the ability of Heat's ImPACT
and ComPACT therapies to perform as designed, to demonstrate safety
and efficacy, as well as results that are consistent with prior
results, the ability to enroll patients and complete the clinical
trials on time and achieve desired results and benefits, the
company’s ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, regulatory limitations relating to the
company’s ability to promote or commercialize its product
candidates for specific indications, acceptance of its product
candidates in the marketplace and the successful development,
marketing or sale of products, the company’s ability to maintain
its license agreements, the continued maintenance and growth of its
patent estate, its ability to establish and maintain
collaborations, its ability to obtain or maintain the capital
or grants necessary to fund its research and development
activities, and its ability to retain its key scientists or
management personnel and the other factors described in the
company’s annual report on Form 10-K for the year ended December
31, 2015 and other filings with the SEC. The information in
this release is provided only as of the date of this release and
the company undertakes no obligation to update any forward-looking
statements contained in this release based on new information,
future events, or otherwise, except as required by law.
Contact:
Jennifer Almond
Investor and Media Relations
919-240-7133
Investorrelations@heatbio.com
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