Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 202...
June 04 2021 - 9:00AM
Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage
biopharmaceutical company focused on developing first-in-class
therapies to modulate the immune system, today announced that Dr.
Roger B. Cohen, MD, Professor of Medicine at the University of
Pennsylvania Perelman School of Medicine, presented an overview of
the latest HS-110 data at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting which is being held from June 4-8,
2021. This poster presentation can be viewed on Heat Biologics'
website at:
https://www.heatbio.com/product-pipeline/scientific-publications.
The ASCO Annual Meeting is the world’s largest oncology conference
showcasing the latest advancements in cancer research.
HS-110, in combination with a checkpoint
inhibitor (CPI), is a potentially transformational agent to improve
survival benefit for patients with non-small cell lung cancer
(NSCLC). This is a first-in-class, allogeneic, off-the shelf
cell-based therapy developed by Heat leveraging its proprietary
gp96 platform. At this year’s ASCO meeting, the Company is pleased
to report the latest data of HS-110 in combination with OPDIVO®
(nivolumab) in two distinct treatment settings in a total of 115
previously treated patients with NSCLC:
- Median overall survival (mOS) of
24.6 months was observed in previously treated, CPI naïve patients
with advanced NSCLC (Cohort A, n=47). This data compares favorably
with published data of Checkmate 057, which reported a mOS of 12.2
months in patients who received nivolumab as single agent in a
similar treatment setting.
- mOS of 11.9 months was reported in
NSCLC patients who were previously treated with CPI and whose
disease had subsequently progressed (Cohort B, n=68). Published
data from other studies stated median OS of 6.8 to 9.0 months for
NSCLC patients treated with chemotherapies after CPI
progression.
- Multiple subset analyses including
injection-site reaction (ISR) and tumor PD-L1 expression were
performed.
- Significantly longer mOS was
observed in patients with ISR compared with those without such a
reaction for both Cohorts A and B.
- Extended survival benefit was
observed in PD-L1 positive patients in Cohort A.
- A trend of improved overall
survival was observed in patients with low blood tumor mutation
burden in Cohort B.
Dr. Roger B. Cohen, Professor of Medicine at the
University of Pennsylvania Perelman School of Medicine, commented,
“HS-110 is a promising agent for treatment of incurable NSCLC. The
latest data presented support further clinical evaluation in
combination with first line regimens that include a CPI as well as
addressing high unmet medical needs for CPI progressors.”
Jeff Wolf, Chief Executive Officer of Heat,
commented, “This data further reinforces the potential utility of
HS-110 in combination with a CPI for multiple treatment settings of
NSCLC. The growing body of clinical data demonstrates that HS-110
in combination with a CPI is well tolerated and has the potential
to enhance survival benefit when given with a CPI. Our latest
results, consistent with previously reported data, provide a strong
foundation for the Company to discuss possible Phase 3 registration
trial designs with the FDA and potential partners.”
About HS-110HS-110 is a
first-in-class, off-the-shelf, allogeneic cell therapy designed to
utilize gp96 for immune activation against multiple tumor testis
antigens. Phase 2 trial of HS-110 in combination with Bristol Myers
Squibb's OPDIVO® (nivolumab) has completed enrollment in patients
with incurable or metastatic NSCLC. OPDIVO® is a programmed death-1
immune checkpoint inhibitor. HS-110 has broad potential for
providing multiple treatment options to NSCLC patients in
combination with a PD-1 inhibitor. Positive interim survival data
has been demonstrated in two distinct treatment settings in
previously treated NSCLC patients who have not been treated with
CPI as well as patients who have progressed during or after
previous treatment with a CPI. Combination of HS-110 and PD-(L)1
therapies may confer additional survival benefit.
About Heat Biologics, Inc.Heat
Biologics is a biopharmaceutical company focused on developing
first-in-class therapies to modulate the immune system. Heat’s gp96
platform is designed to activate immune responses against cancer or
infectious diseases. The Company has multiple product candidates in
development leveraging the gp96 platform, including HS-110, which
has completed enrollment in its Phase 2 trial, and a COVID-19
vaccine program in preclinical development. In addition, Heat
Biologics is also developing a pipeline of proprietary
immunomodulatory antibodies and cell-based therapies, including
PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking StatementThis
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, expectation, and assumptions and include
statements such as the HS-110, in combination with a
checkpoint inhibitor (CPI), being a potentially transformational
agent to improve survival benefit for patients with non-small cell
lung cancer (NSCLC), HS-110 being a promising agent for treatment
of incurable NSCLC, potential utility of HS-110 in combination with
a CPI for multiple treatment settings of NSCLC, HS-110 in
combination with a CPI having the potential to enhance survival
benefit when given with a CPI and HS-110 being administered in
combination with first line regimens that include a CPI as well as
addressing high unmet medical needs for CPI progressors. These
statements are subject to a number of risks and uncertainties, many
of which are difficult to predict, including the ability of Heat's
therapies to perform as designed, to demonstrate safety and
efficacy, as well as results that are consistent with prior
results, the ability of HS-110, in combination with a CPI to be
utilized in multiple treatment settings of NSCLC and to improve
survival benefit for patients with non-small cell lung cancer
(NSCLC), the ability HS-110 to be administered in combination with
first line regimens that include a CPI as well as addressing high
unmet medical needs for CPI progressors, Heat's vaccine platform to
provide protection against COVID-19, the ability to enroll patients
and complete the clinical trials on time and achieve desired
results and benefits, especially in light of COVID-19, Heat's
ability to obtain regulatory approvals for commercialization of
product candidates or to comply with ongoing regulatory
requirements, regulatory limitations relating to Heat'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, Heat'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, its ability to continue to maintain its
listing on the Nasdaq Capital Market and its ability to retain its
key scientists or management personnel, and the other factors
described in Heat's most recent annual report on Form 10-K filed
with the SEC, and other subsequent filings with the SEC. The
information in this release is provided only as of the date of this
release, and Heat 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.
Media and Investor Relations
ContactDavid Waldman+1 919 289
4017investorrelations@heatbio.com
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