Galectin Therapeutics Receives FDA Approval to Proceed with Combination Immunotherapy Trial in Head and Neck Cancer
October 12 2022 - 8:00AM
Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading
developer of therapeutics that target galectin-3, today announced
that its Investigational New Drug (IND) application for belapectin
in combination with a checkpoint inhibitor for the treatment of
Head and Neck cancer has been filed with the U.S. Food and Drug
Administration (FDA) Oncology division. Galectin Therapeutics also
received a Study May Proceed letter for a Phase 2 clinical trial
entitled “A Phase 2 Study of the Efficacy and Safety of Belapectin
in Combination with Pembrolizumab (Keytruda®) as First-Line
Treatment in subjects with Recurrent/Metastatic PD-L1 Positive
Squamous Cell Carcinoma of the Head and Neck.”
Joel Lewis, President and Chief Executive Officer of Galectin
Therapeutics, stated: “This second IND is a significant milestone
and exemplifies the dedication of our team towards furthering
development of belapectin to better the lives of patients in a
variety of important diseases. Further, we acknowledge the input
and review of this IND by our clinical experts, Drs. Chetan
Bettegowda, Nishant Agrawal, and Ari Rosenberg. This effort
resulted in the Company’s first fully electronic filing, which
captured all available scientific data. This was a massive
undertaking, and I am extremely proud of our team’s effort and
dedication to completing this important milestone, while
simultaneously managing our NASH cirrhosis trial.
As we celebrate this achievement, and explore options for our
oncology program, the Company will continue its focus on our
pivotal global NAVIGATE trial in NASH cirrhosis. We now have 11
additional active sites in Mexico and have made steady progress on
enrollment, which, as we have previously stated, we expect to
complete around the end of 2022.”
Pol Boudes, M.D., Chief Medical Officer of Galectin
Therapeutics, stated that: “The prior investigator-initiated study
in advanced metastatic melanoma and head and neck cancer using
belapectin and Keytruda® provided a strong rationale for proceeding
with this Phase 2 trial. To ensure the most appropriate design of
our trial, we engaged in extensive consultations with expert
oncologists in melanoma and head and neck cancer, which was crucial
in ensuring we had the optimal clinical trial design. We are also
thankful for the collaborative comments we received from the FDA
during the submission process. There is a significant need to
improve upon existing therapies in this area, and we hope this new
combination will make a difference for patients affected with head
and neck cancer.”
Mr. Lewis added: “The next steps for the Company’s oncology
program will be to engage potential partners to collaborate on our
program and planning for financing the trial, which, if successful,
could begin next year. We will keep updating on our progress, as
information becomes available.”
About BelapectinBelapectin 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, and these results provide the
basis for the conduct of the NAVIGATE trial. The NAVIGATE trial
(www.NAVIGATEnash.com), titled “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 has a significant role in cancer, and the Company has
supported a Phase 1b study in combined immunotherapy of belapectin
and KEYTRUDA in advanced melanoma and in head and neck cancer. This
trial provided a strong rationale for moving forward into a
Company-sponsored Phase 2 development program, which the company is
exploring.
About Head and Neck Cancer Most head and neck
cancers are derived from the mucosal epithelium in the oral cavity,
pharynx, and larynx and are collectively known as head and neck
squamous cell carcinoma (HNSCC). HNSCC was the sixth most common
cancer worldwide in 2018. Most patients with HNSCC are diagnosed
with locally advanced disease comprising stages III and IV. Among
patients with locally advanced disease, 50-60% will develop
locoregional relapse or distant metastases within 2 years. Despite
advances in treatments, including surgery, radiotherapy,
chemotherapy, and/or targeted systemic treatments, prognosis
remains poor especially for patients with recurrent or metastatic
HNSCC. In a Phase 1 study, the combination of belapectin with
pembrolizumab enhanced the clinical and immunological effects of
the PD-1 inhibitor and demonstrated an objective response rate of
33% in Subjects with HNSCC. Treatment with belapectin and
pembrolizumab was also associated with fewer immune-mediated
adverse events than anticipated with pembrolizumab monotherapy. The
current study is designed to confirm these clinical results in a
larger number of Subjects.
About Fatty Liver Disease with Advanced Fibrosis and
CirrhosisNon-alcoholic steatohepatitis (NASH) has become a
common disease of the liver with the rise in obesity and other
metabolic diseases. NASH is estimated to affect up to 28 million
people in the U.S. It is characterized by the presence of excess
fat in the liver along with inflammation and hepatocyte damage
(ballooning) in people who consume little or no alcohol. Over time,
patients with NASH can develop excessive fibrosis, or scarring of
the liver, and ultimately liver cirrhosis. It is estimated that as
many as 1 to 2 million individuals in the U.S. will develop
cirrhosis as a result of NASH, for which liver transplantation is
the only curative treatment available. Approximately 9,000 liver
transplants are performed annually in the U.S. There are no drug
therapies approved for the treatment of liver fibrosis or
cirrhosis.
About Galectin TherapeuticsGalectin
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 involved in multiple inflammatory, fibrotic, and
malignant diseases, for which it has Fast Track designation by the
U.S. Food and Drug Administration for NASH with advanced fibrosis
and cirrhosis. 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.
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 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 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 coronavirus may continue to
impact NASH patient populations around the globe and slow trial
enrollment and prolong the duration of the trial and significantly
impact associated costs. 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, 2021, 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
belapectin (GR-MD-02).
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