Heat Biologics Remains on Track to Achieve Multiple Topline Data Readouts this Quarter
October 13 2016 - 7:00AM
Heat Biologics, Inc. (Nasdaq:HTBX), an
immuno-oncology company developing novel therapies that activate a
patient’s immune system against cancer, announced that it continues
to remain on track to report topline data this quarter from its
Phase 2 trials evaluating HS-410 and HS-110 for the treatment of
non-muscle invasive bladder cancer (NMIBC) and non-small cell lung
cancer (NSCLC), respectively, as well as its Phase 1b trial
evaluating HS-110 in combination with Bristol-Myers Squibb’s
anti-PD-1 checkpoint inhibitor, Opdivo®, for the treatment of
NSCLC.
“We are pleased with the progress we are making
and look forward to reporting top-line data in both our NMIBC and
NSCLC trials later this quarter,” commented Jeff Wolf, Heat’s
Founder and CEO. “We are encouraged by our early data in
bladder cancer that suggests we are activating a robust
antigen-specific immune response and our data in lung cancer that
suggest HS-110 may improve response rates for patients with ‘cold
tumors’ who typically have lower response rates to checkpoint
inhibitor monotherapy.”
About Heat Biologics, Inc. Heat
Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company
developing novel therapies that activate a patient’s immune system
against cancer. Heat’s highly specific T cell-stimulating
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); T cell co-stimulation
to further enhance patients’ immune response; and reversal of
tumor-induced immune suppression. Currently, Heat is
conducting a Phase 2 trial with its HS-410 (vesigenurtacel-L) in
patients with non-muscle invasive bladder cancer (NMIBC) and a
Phase 1b trial with its HS-110 (viagenpumatucel-L) in combination
with an anti-PD-1 checkpoint inhibitor to treat patients with
non-small cell lung cancer (NSCLC). 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 timing of reporting topline data,
the suggestion from the early data in bladder cancer of activation
of a robust antigen-specific immune response, the suggestion
from data in lung cancer that HS-110 may improve response rates for
patients with ‘cold tumors’ who typically have lower response rates
to checkpoint inhibitor monotherapy 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:
For Investor Inquiries:
David Waldman
919-240-7133
Investorrelations@heatbio.com
For Media Inquiries:
Deanne Eagle
Planet Communications
917-837-5866
deanne@planetcommunications.nyc
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