Heat Biologics Resumes Enrollment in its Non-Small Cell Lung Cancer Trial Evaluating HS-110 in Combination with Anti-PD-1 Che...
September 14 2016 - 7:00AM
Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), an immuno-oncology
company developing novel therapies that activate a patient’s immune
system against cancer, announced that the company has resumed
enrollment in its Phase 1b trial evaluating HS-110 in combination
with nivolumab (Opdivo®), a Bristol-Myers Squibb anti-PD-1
checkpoint inhibitor, for the treatment of non-small cell lung
cancer (NSCLC). The decision to resume trial enrollment was
based on the positive data reported in June, including two clinical
responses in “cold tumor” patients, and enabled by additional
company funding through the exercise of warrants, as reported in
the latest company financial and corporate update.
“We are pleased to resume enrollment in this
trial, especially following the three case studies we reported
earlier this year in June, where two out of the three patients
showed an increase in CD8+ T cells in biopsy samples after
treatment with HS-110 plus nivolumab,” stated Taylor Schreiber,
M.D., Ph.D., Heat’s Chief Scientific Officer. “These early
data suggest that HS-110 in combination with nivolumab may improve
response rates for patients with ‘cold tumors’ who typically have
lower response rates to checkpoint inhibitor
monotherapy.”
The anti-PD-1 combination trial is designed to
evaluate whether HS-110 expands the proportion of NSCLC patients
responsive to PD-1 blockade, particularly in the estimated 50% of
patients lacking an anti-tumor immune response. There are
currently eight patients enrolled and the company expects to report
topline 6-month data for these patients in the fourth quarter of
this year. Heat intends to complete enrollment of each of the
two 9-patient cohorts consistent with the original design of the
trial, with the potential to expand each cohort up to 30
patients. The topline data for additional patients enrolled
in the trial are anticipated within the next twelve months.
“It is important to note that the trial is
structured as a Phase 1b/Phase 2 with pre-specified thresholds in
place to expand the trial to a full Phase 2. We believe that
we are close to fulfilling these thresholds given the positive
clinical responses we have already reported,” added Dr. Schreiber.
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); reversal of
tumor-induced immune suppression; and T cell co-stimulation to
further enhance patients’ immune response. 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 potential of HS-110 to convert
“cold” to “hot tumors” in NSCLC patients, the suggestion that
HS-110 in combination with nivolumab may improve response rates for
patients with “cold tumors,” the intent to complete enrollment of
each of the two 9-patient cohorts consistent with the original
design of the trial, with the potential to expand each cohort up to
30 patients, the expected reporting of topline 6-month data in the
fourth quarter of 2016, the anticipated topline data for additional
patients enrolled in the trial within the next twelve months, the
belief that the company is close to fulfilling pre-specified
thresholds to expand the trial to a full Phase 2 and the 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 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, 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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