Heat Biologics Reports Positive Interim Phase 2 Lung Cancer Results in Patients Treated with HS-110 in Combination with a Che...
March 21 2017 - 7:00AM
ELISPOT results suggest that HS-110 plays an
integral role in tumor reduction and may enhance efficacy of
checkpoint inhibitors in lung cancer patients
Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), a leader in the
development of immunotherapies designed to activate a patient’s
immune system against cancer, announced the latest results of its
ongoing Phase 2 clinical trial of 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).
Fifteen patients have completed the HS-110/nivolumab
combination treatment to-date and 12 of these 15 patients were
evaluable for ELISPOT analysis. Researchers reported a strong
correlation between T cell activation, tumor reductions and
increased overall survival in these 12 patients. These data
reinforce preliminary results seen in the first eight patients as
reported last December at the International Association for the
Study of Lung Cancer Annual Meeting.
Key findings:
- Immune responses to HS-110 were observed in all 5 patients that
exhibited tumor reductions.
- No tumor reductions were observed in patients that did not
mount an immune response to HS-110.
- The timing of immune responses to HS-110 corresponded to the
timing of observed clinical responses, and those responses appear
to be sustained.
- To-date, 5 patients have been enrolled in the low tumor
infiltrating lymphocytes (TIL) cohort (patients with “cold”
tumors). Three of these 5 patients (60%) have experienced
significant tumor reduction, which is higher than the 10% response
rate of low TIL patients reported for existing data on nivolumab
alone.1
Researchers reported continued indications that
patients are mounting a vaccine-mediated immune response to the
vaccine lysate, as well as to peptides derived from cancer-specific
antigens in their peripheral blood cells via ELISPOT
analysis. ELISPOT analysis is the most widely used method for
monitoring cellular immune responses in humans. This suggests
that the HS-110 vaccine is making a measurable contribution to the
desired cancer-specific immune response.
Of the 15 patients who have completed the
HS-110/nivolumab combination treatment to-date, 12 were evaluable
for ELISPOT analysis. Six of the 12 evaluable patients met
the criteria for a positive ELISPOT response to vaccine lysate, and
5 of these 6 patients experienced tumor reductions and increased
overall survival. All 5 patients who exhibited a clinical
response also saw an immune response to HS-110. Of the 6
patients who did not respond by ELISPOT analysis, 5 patients saw
tumor progression and 1 patient discontinued treatment due to a
non-serious adverse event.
These data suggest that the 5 tumor reductions
seen thus far in the 15 evaluated patients are the result of
synergistic activity between HS-110 and anti-PD-1 therapy.
Researchers also reported that the safety profile continues
to be favorable in the HS-110/nivolumab combination, with no
evidence of additional toxicities seen as compared to existing data
on nivolumab alone.
“Checkpoint inhibitors, such as nivolumab, are
currently effective in treating approximately 10% of lung cancer
patients with low TIL and about 20% of patients overall in the 2nd
line setting,” said Jeff Hutchins, Ph.D., Heat’s Chief Scientific
Officer and Senior Vice President of Preclinical Development.
“Our results appear to further validate the expected mechanism of
action of our approach in combination with checkpoint inhibitors,
with a continuing trend towards early and sustained T cell
activation in the peripheral blood cells. All patients who
mounted a sustained immune response to HS-110 exhibited substantial
tumor reductions. We do not see any tumor reduction in
patients who did not mount a response to the vaccine.
Furthermore, if ELISPOT assay results continue to correlate with
clinical results, the combination of HS-110 and nivolumab may
become an attractive therapeutic approach for the approximately 80%
of patients that do not respond well to nivolumab alone,
particularly with the positive safety profile of this combination
seen to-date.”
1Teng et al, Cancer Research 75(11) June 1,
2015
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, 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 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 ELISPOT results suggesting that
HS-110 plays an integral role in tumor reduction and may enhance
efficacy of checkpoint inhibitors in lung cancer patients,
continued indication that patients are mounting a vaccine-mediated
immune response to the vaccine lysate, as well as peptides derived
from cancer-specific immune response, the suggestion that HS-110
vaccine is making a measurable contribution to the desired
cancer-specific immune response, the suggestion that the 5 tumor
reductions seen thus far in the 15 evaluated patients are the
result of synergistic activity between HS-110 and anti-PD-1
therapy, the results appearing to further validate the expected
mechanism of action of Heat’s approach in combination with
checkpoint inhibitors, with a continuing trend towards early and
sustained T cell activation in the peripheral blood cells, the
combination of HS-110 and nivolumab may become an attractive
therapeutic approach for the approximately 80% of patients that do
not respond well to nivolumab alone if ELISPOT assay results
continue to correlate with clinical results, 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 to
develop its product candidates and prove them safe and efficacious,
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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