Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of
therapeutics that target galectin proteins, today announced that a
paper published in the peer-reviewed Journal for ImmunoTherapy of
Cancer (JITC), the highest ranked fully open access immunology
journal, provides further clinical evidence that using belapectin,
a potent galectin-3 inhibitor, in combination with pembrolizumab
(KEYTRUDA®), a PD-1 inhibitor, significantly enhances tumor
response to immunotherapy in patients with advanced metastatic
melanoma (MM) and head and neck squamous cell carcinoma (HNSCC).
The paper, titled
“Enhancing Clinical and Immunological Effects of anti-PD-1 with
Belapectin, a Galectin-3 Inhibitor” (doi:10.1136/jitc-2021-002371)
describes results from an ongoing Phase 1 clinical study, a
collaboration between Galectin Therapeutics and Providence Cancer
Institute in Portland, Oregon.
Following the recent
publication of positive preclinical results that showed the
inhibition of galectin-3 in combination with an agonist anti-OX40
monoclonal antibody reprograms the tumor microenvironment to favor
anti-tumor activity, the current study tests the clinical
hypothesis that galectin-3 blockade with belapectin in combination
with pembrolizumab enhances tumor response for patients with
advanced MM or HNSCC.
In the study, as previously disclosed, an objective response was
observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients. This
compares favorably to published response rates on pembrolizumab
alone. The authors noted that the combination was associated with
fewer immune-mediated adverse events than anticipated with
pembrolizumab alone. In addition, the analysis of patients’ tumor
tissue revealed reduced monocytic myeloid-derived suppressor cells
and increased effector memory T-cell activation in responders
compared with non-responders. Also, an increased baseline
expression of galectin-3 positive tumor cells correlated with
clinical response.
“Immunotherapy is a
significant breakthrough in the treatment of many cancers, but
tumor-induced immune suppression contributes to treatment
resistance. Galectin-3 is an important driver of this tumor-induced
immunosuppression, and this clinical study constitutes
proof-of-concept that the addition of belapectin, a galectin-3
inhibitor, to a PD-1 inhibitor can benefit cancer patients,” said
Dr. Brendan Curti, M.D., Earle A. Chiles Research Institute, a
division of Providence, and the first author of the paper.
“The analysis of
patients’ tumor tissues is consistent with previously published
pre-clinical data with belapectin and confirms the ability of
belapectin to modulate the tumor microenvironment to favor
anti-tumor activity. The possibility to improve the tolerance and
safety of immunotherapy is also very exciting,” commented Pol F.
Boudes, M.D., Chief Medical Officer of Galectin Therapeutics.
“These proof-of-concept clinical data provide a strong rationale to
initiate a randomized placebo-controlled phase 2 clinical trial to
evaluate the efficacy and safety of belapectin in combination with
a PD-1 inhibitor compared to a PD-1 inhibitor alone in this cancer
patient population. We look forward to continuing our work with
Providence Cancer Institute, and we anticipate the upcoming release
of additional data from the expansion cohort in this study.”
About Belapectin
(GR-MD-02)
Belapectin (GR-MD-02) is
a complex carbohydrate drug that targets galectin-3, a critical
protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays
a major role in diseases that involve scarring of organs including
fibrotic disorders of the liver, lung, kidney, heart and vascular
system. Belapectin binds to galectin-3 and disrupts its function.
Preclinical data in animals have shown that belapectin has robust
treatment effects in reversing liver fibrosis and cirrhosis. A
Phase 2 study showed belapectin may prevent the development of
esophageal varices in NASH cirrhosis; these results provide the
basis for the conduct of the NAVIGATE trial. The NAVIGATE trial
(NAVIGATEnash.com), entitled “A Seamless Adaptive Phase 2b/3,
Double-Blind, Randomized, Placebo-controlled Multicenter,
International Study Evaluating the Efficacy and Safety of
Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in
NASH Cirrhosis” began enrolling patients in June 2020 and is posted
on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a
significant role in cancer, and the Company is supporting a Phase 1
study in combined immunotherapy of belapectin and KEYTRUDA in
treatment of advanced melanoma and in head and neck cancer.
About Galectin
Therapeutics
Galectin Therapeutics is
dedicated to developing novel therapies to improve the lives of
patients with chronic liver disease and cancer. Galectin’s lead
drug belapectin (formerly known as GR-MD-02) is a
carbohydrate-based drug that inhibits the galectin-3 protein which
is directly involved in multiple inflammatory, fibrotic, and
malignant diseases, for which it has Fast Track designation by the
U.S. Food and Drug Administration. The lead development program is
in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most
advanced form of NASH-related fibrosis. This is the most common
liver disease and one of the largest drug development opportunities
available today. Additional development programs are in treatment
of combination immunotherapy for advanced melanoma and other
malignancies. Advancement of these additional clinical programs is
largely dependent on finding a suitable partner. Galectin seeks to
leverage extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. Additional information is
available at www.galectintherapeutics.com.
About Providence
Cancer Institute
Providence Cancer
Institute, a part of Providence St. Joseph Health, offers the
latest in cancer services, including diagnostic, treatment,
prevention, education, support and internationally renowned
research. Providence Cancer Institute is home to the Earle A.
Chiles Research Institute, a world-class research facility located
within the Robert W. Franz Cancer Center in Portland, Oregon, and
is a recognized leader in the field of cancer immunotherapy since
1993. Investigators lead more than 400 active clinical trials in
key areas such as cancers of the: breast, colon/rectum, prostate,
lung, esophagus, liver and pancreas, head and neck, ovary, skin and
blood. Other studies are investigating treatments for COVID-19.
Learn more at providenceoregon.org/cancer.
Forward Looking
Statements
This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
relate to future events or future financial performance, and use
words such as “may,” “estimate,” “could,” “expect” and others. They
are based on management’s current expectations and are subject to
factors and uncertainties that could cause actual results to differ
materially from those described in the statements. These statements
include those regarding the hope that Galectin’s development
program for belapectin will lead to the first therapy for the
treatment of fatty liver disease with cirrhosis and those regarding
the hope that our lead compounds will be successful in cancer
immunotherapy and in other therapeutic indications. Factors that
could cause actual performance to differ materially from those
discussed in the forward-looking statements include, among others,
that trial endpoints required by the FDA may not be achieved;
Galectin may not be successful in developing effective treatments
and/or obtaining the requisite approvals for the use of belapectin
or any of its other drugs in development; the Company may not be
successful in scaling up manufacturing and meeting requirements
related to chemistry, manufacturing and control matters; the
Company’s current NAVIGATE clinical trial and any future clinical
studies as modified to meet the requirements of the FDA may not
produce positive results in a timely fashion, if at all, and could
require larger and longer trials, which would be time consuming and
costly; plans regarding development, approval and marketing of any
of Galectin’s drugs are subject to change at any time based on the
changing needs of the Company as determined by management and
regulatory agencies; regardless of the results of any of its
development programs, Galectin may be unsuccessful in developing
partnerships with other companies or raising additional capital
that would allow it to further develop and/or fund any studies or
trials. Galectin has incurred operating losses since inception, and
its ability to successfully develop and market drugs may be
impacted by its ability to manage costs and finance continuing
operations. Global factors such as COVID-19 may limit access to
NASH patient populations around the globe and slow trial enrollment
and prolong the duration of the trial and significantly impact
associated costs as well as impact other trial related activities
including, amongst others, manufacturing and regulatory reviews.
For a discussion of additional factors impacting Galectin’s
business, see the Company’s Annual Report on Form 10-K for the year
ended December 31, 2020, and subsequent filings with the SEC. You
should not place undue reliance on forward-looking statements.
Although subsequent events may cause its views to change,
management disclaims any obligation to update forward-looking
statements.
Company
Contact:Jack Callicutt, Chief Financial Officer(678)
620-3186ir@galectintherapeutics.com
Galectin Therapeutics and
its associated logo is a registered trademark of Galectin
Therapeutics Inc. Belapectin is the USAN assigned name for Galectin
Therapeutics’ galectin-3 inhibitor GR-MD-02.
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