Galectin Therapeutics, Inc. and Providence Cancer Institute Receive Patent on the Use of Belapectin (GR-MD-02) in Cancer Immu...
September 17 2019 - 8:00AM
Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of
therapeutics that target galectin proteins, and Providence Cancer
Institute announced today they have received notice of issuance of
U.S. Patent Number 10,398,778 titled "Method for Enhancing Specific
Immunotherapies in Cancer Treatment.” The patent's principal claims
cover method of use of Galectin’s drug candidate, belapectin
(GR-MD-02), as a means to enhance the effectiveness of specific
immunotherapies in cancer treatment. The patent is expected to
provide broad protection for the use of belapectin for
compositions, methods of using and methods of manufacturing
compositions used alone or in combination with other targeted
immunotherapies in treating cancer. The patent coverage extends to
2033.
“This is an important patent that protects the use of belapectin
in cancer immunotherapy,” said Harold Shlevin, Ph.D., CEO and
President of Galectin Therapeutics. “Immunotherapy holds great
potential for treating advanced cancers, but response to treatment
is highly variable. Providence Cancer Institute is conducting
groundbreaking research using belapectin in combination with cancer
immunotherapy, with indications that belapectin may boost the
effectiveness of treatment. This patent expands the IP portfolio of
Galectin to capture the importance of this work for the benefit of
the Company and its stockholders, and for Providence Cancer
Institute.”
The patent is the result of work done by Providence Cancer
Institute in a Phase 1B investigator-initiated trial using
belapectin in combination with KEYTRUDA® to treat advanced melanoma
as well as head and neck cancer. Data from this early open-label
study shows a 50% objective response rate in advanced melanoma with
belapectin in combination with KEYTRUDA. The published data on
KEYTRUDA alone have shown an objective response rate of 33% in this
patient population.
“Belapectin shows strong results when given with checkpoint
blockade (anti-PD-1) immunotherapy. The response rates to
combination therapy observed overall in advanced melanoma and head
and neck cancer patients were better than with KEYTRUDA alone,
particularly given the low response rates of anti-PD-1 monotherapy
in head and neck cancer. There is a significant clinical need for
better options for these patients,” said William L. Redmond, Ph.D.,
Associate Member, Laboratory of Cancer Immunotherapy, and Director,
Immune Monitoring Laboratory at the Earle A. Chiles Research
Institute, a division of Providence Cancer Institute. “In addition
to the encouraging clinical responses to combination therapies
involving belapectin with KEYTRUDA, we continue to make progress on
identifying immunological biomarkers that correlate with favorable
responses.”
The methods and compositions of the invention relate to the
enhancement of specific immunotherapies in cancer treatment. In
particular, aspects of the invention relate to novel approaches to
boost immune function using a complex carbohydrate pharmaceutical
compound alone or in combination with other targeted immunotherapy
to increase the efficacy of cancer immunotherapy.
About Belapectin (GR-MD-02)Belapectin (also
known as GR-MD-02) is a complex carbohydrate drug that targets
galectin-3, a critical protein in the pathogenesis of fatty liver
disease 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. The drug binds to
galectin-3 proteins and disrupts its function. Preclinical data in
animals have shown that belapectin has robust treatment effects in
reversing liver fibrosis and cirrhosis. Belapectin also has robust
efficacy in pre-clinical cancer models in combination with
immunotherapy agents.
About Galectin TherapeuticsGalectin
Therapeutics is developing promising carbohydrate-based therapies
for the treatment of fibrotic liver disease and cancer based on the
Company's unique understanding of galectin proteins, which are key
mediators of biologic function. Galectin seeks to leverage
extensive scientific and development expertise as well as
established relationships with external sources to achieve
cost-effective and efficient development. The Company is pursuing a
development pathway to clinical enhancement and commercialization
for its lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
About Providence Cancer InstituteProvidence
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. Visit providenceoregon.org/cancer to learn more.
Forward Looking StatementsThis 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 (GR-MD-02) 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. Factors that could cause actual performance
to differ materially from those discussed in the forward-looking
statements include, among others, that for the clinical trials in
cancer immunotherapy, Galectin has relied on the trials undertaken
by Providence, which limits the number of patients included in the
trials; Galectin may be unsuccessful in expanding the scope of the
cancer immunotherapy trials, and the results of expanded trials may
not be positive; Galectin may not be successful in developing
effective treatments and/or obtaining the requisite approvals for
the use of belapectin; manufacturing of drug product now in
scale-up may not be successful or meet regulatory expectations, the
Company’s Phase 3 clinical trial for the treatment of fatty liver
disease, now in the initial planning stages, and any future
clinical studies, including those in connection with cancer
immunotherapy may not proceed and may not produce positive results
in a timely fashion, if at all, and could prove 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. 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, 2018, 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.
KEYTRUDA® is a registered trademark of Merck & Co., Inc.
Investor Contact:Galectin Therapeutics, Inc.Jack Callicutt,
Chief Financial Officer(678)
620-3186ir@galectintherapeutics.com
Media Contact:Gregory FCARachel Giltz, Senior Account
Executive(215) 297-3607rachel@gregoryfca.com
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