Reports Positive Data on Primary Endpoint with
Positive Safety Data
Heat Biologics, Inc. (Nasdaq:HTBX), a leader in the development of
gp96-based immunotherapies designed to activate a patient’s immune
system to fight cancer, reported topline response and survival
results in the ongoing Phase 1b study evaluating HS-110, in
combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint
inhibitor, nivolumab (Opdivo®), for the treatment of non-small cell
lung cancer (NSCLC), at the International Association for the Study
of Lung Cancer Annual Meeting in Vienna, Austria.
In an oral presentation, principal investigator,
Daniel Morgensztern, MD, Associate Professor of Medicine and
Director of Thoracic Oncology, Washington University School of
Medicine, reported that one-year results from the first eight trial
patients showed that the HS-110/nivolumab combination was
well-tolerated, with a safety profile consistent with single agent
nivolumab. There were no additional toxicities seen in
HS-110/nivolumab combination compared to existing data on single
agent nivolumab alone. HS-110 generated a robust antigen-specific
immune response in several patients, consistent with the mechanism
of action seen in other HS-110 trials. Additionally, the
patients who responded best to the combination therapy (immune
responders) had longer overall survival and better objective
response rate (ORR) than the non-immune responders, even though
they had the same baseline immune function.
Immune responders in the study saw a 50% ORR,
while non-immune responders saw a 0% ORR. This is important, as
checkpoint inhibitors have been shown, independently, to be much
more effective in tumors with pre-existing, high tumor-infiltrating
lymphocytes (TIL). As such, there now exists an acute need to
address the large proportion of non-responders with low-TIL
tumors.
Moreover, the immune responders had a better
median overall survival (OS) than non-immune responders. The
one-year OS is currently 50% for the responders, and 25% for the
non-responders. Finally, immune responders also saw a better median
OS at 12.7 months, than non-immune responders, who saw a median OS
of 7.1 months. Researchers concluded that immune response may
correlate with clinical efficacy and that HS-110 may have
synergistic activity with immune checkpoint inhibitors.
“We are encouraged by the data generated in the
trial,” said Dr. Morgensztern. “We were impressed by the ability of
HS-110 to activate a CD8+ T cell immune response. The
HS-110/nivolumab combination is worth continued exploration in the
treatment of lung cancer, as the HS-110 mechanism of action is
potentially synergistic with anti-PD-1 checkpoint inhibitors.”
“We’ve continued to see ELISPOT analysis
correlate with clinical efficacy with HS-110 in NSCLC, an
encouraging trend also observed in other trials with HS-110,” said
Taylor Schreiber, MD, PhD, Heat’s Chief Scientific Officer. “We are
seeing trends between TIL status and TIL increases after treatment
among these patients, which may speak to the ability of HS-110 to
convert “cold” tumors to “hot” tumors to increase the effectiveness
of PD-1 checkpoint therapy in lung cancer.”
“These new data are further confirmation of the
ability of our ImPACT platform, which has been administered to over
200 patients in 4 clinical studies, to generate a robust
antigen-specific immune response, an important component of
immunotherapy,” said Jeff Wolf, Heat’s CEO. “The future of
immuno-oncology lies in combining synergistic modalities to create
more effective treatments. At Heat, we are actively pursuing
opportunities to combine our ImPACT and ComPACT platforms with
checkpoint inhibitors, and other promising immunotherapies to
improve patient outcomes.”
Heat plans to hold an investor call on December
8th at 8:30 a.m. ET to discuss its overall clinical strategy moving
forward. The call will be available on the company’s website at
www.heatbio.com, or by calling 866-320-0174 for U.S. callers, or +1
785-424-1631 for international callers. A webcast will also
be archived on the company’s website and a telephone replay of the
call will be available approximately one hour following the call,
through midnight December 15, 2016, and can be accessed by calling:
877-481-4010 (U.S. callers) or +1 919-882-2331 (international
callers) and entering conference ID: 10169.
The oral presentation will be uploaded to Heat’s
website at http://www.heatbio.com/our-science/publications 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).
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. The Zolovax patent portfolio also
includes gp96 vaccines targeting West Nile virus, Dengue and yellow
fever among others.
For more information, please visit
www.heatbio.com.
Forward Looking Statements This
press release includes forward-looking statements 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
conclusion that immune response may correlate with clinical
efficacy and that HS-110 may have synergistic activity with immune
checkpoint inhibitors, the belief that the HS-110/nivolumab
combination is worth continued exploration with a mechanism of
action synergistic with anti-PD-1 checkpoint inhibitors to improve
treatment in lung cancer, the ability of HS-110 to convert “cold”
tumors to “hot” tumors to increase the effectiveness of PD-1
checkpoint therapy in lung cancer and the other potential of Heat’s
ImPACT and ComPACT therapies. These statements are subject to a
number of risks and uncertainties, many of which are difficult to
predict, including the ability of Heat's ImPACT and ComPACT
therapies to perform as designed, the ability to enroll patients
and complete the clinical trials on time, the ability to achieve
similar results in a larger patient population and other factors
described in our annual report on Form 10-K for the year ended
December 31, 2015 and our other filings with the SEC. The
information in this release is provided only as of the date of this
release, and we undertake 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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