Combination Immunotherapy of Pembrolizumab with the Galectin-3 Inhibitor GR-MD-02 Shows Promising Early Results in Treatment ...
November 13 2017 - 8:30AM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
and Providence Cancer Institute today announced the presentation of
preclinical and early clinical data from an investigator-initiated
Phase 1 clinical trial of GR-MD-02 used in combination with
pembrolizumab (KEYTRUDA®). Data of two complimentary abstracts were
presented Nov. 11, 2017 at the Annual Meeting of the Society for
Cancer Immunotherapy in National Harbor, Md., by William L.
Redmond, Ph.D., Earle A. Chiles Research Institute, a division of
Providence Cancer Institute (data posted).
Three patients in cohort 2 (4 mg/kg GR-MD-02) have now been
completed to add to the six patients in dose cohort 1 (2 mg/kg
GR-MD-02). One patient in the first cohort had head and neck
cancer, while the remaining eight patients had advanced melanoma.
Five patients with advanced melanoma had objective responses after
five courses of every three-week therapy, with three partial
responses and two complete responses. All the patients in the
second cohort had an objective response. Please refer to the posted
data to review additional information on the patients who
responded.
An infographic accompanying this release is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/29964758-bae9-4bc0-8155-fc11eda6e8e5
“In addition to the encouraging clinical responses seen in this
study, we are making progress on identifying immunological markers
that may predict clinical responses to the combination therapy,”
said Redmond, associate member, Laboratory of Cancer Immunotherapy,
and director, Immune Monitoring Laboratory. “In this regard, we
have shown that clinical responders to the combination of GR-MD-02
and pembrolizumab may have reduced myeloid-derived suppressor cells
following treatment.”
The Providence Cancer Institute translational medicine team
conducted two phase 1 clinical trials, initiated under direction of
principal investigator Brendan D. Curti, M.D., director,
Genitourinary Oncology Research and Immunotherapy Clinical Program,
and co-director, Melanoma Program.
GR-MD-02 was also combined in an investigator-led trial with
ipilimumab (Yervoy®) in patients with advanced melanoma
(https://clinicaltrials.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=6).
Seven subjects treated with the lowest two dose cohorts of GR-MD-02
(1 and 2 mg/kg) have been completed with no safety signals
identified due to GR-MD-02. In these low dose initial cohorts,
there were no notable changes in the peripheral immune signature.
Due to changes in the standard of care for metastatic melanoma
(i.e., approval of KEYTRUDA®), recruitment has been slowed
significantly.
“We are encouraged by these early safety and efficacy results
and look forward to further data on GR-MD-02 used in combination
with pembrolizumab in patients with metastatic melanoma or head and
neck cancer,” said Curti. “An objective response rate of five out
of eight patients (62.5%) with advanced melanoma, including two
complete responses, is very encouraging and compares favorably with
the known response rates with pembrolizumab alone (ORR of ~ 33%).
We have begun enrolling cohort 3 (GR-MD-02 8 mg/kg), which will
include at least 10 patients with melanoma to provide a larger
group of patients to evaluate. We hope to report additional data in
mid-2018 when we anticipate a decision on progressing to phase 2.
This decision will be based on the response rate of the combination
with GR-MD-02 as compared to historical response rates to
pembrolizumab alone.”
“Galectin Therapeutics is delighted with our collaboration and
the excellent work by Providence Cancer Institute,” said Peter
Traber, M.D., CEO and CMO of Galectin Therapeutics. “It is known
that galectin-3 produced by tumors is important in avoidance of
immune recognition by cancer cells, and we are gratified by the
large body of pre-clinical work and these early clinical trials
that may support the combination of our galectin-3 inhibitor,
GR-MD-02, with immune checkpoint inhibitors. It is important to
note that not all galectin-3 inhibitors may be effective, as we
have shown that a previous drug GM-CT-01 (DAVANAT®) had no effect
in the same pre-clinical models. Finally, the use of combination
immunotherapy with GR-MD-02 is covered by a joint
Galectin-Providence U.S. patent with exclusive rights granted to
Galectin.”
About GR-MD-02GR-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 proteins and disrupts
their function. Preclinical data in animals have shown that
GR-MD-02 has robust treatment effects in reversing liver fibrosis
and cirrhosis.
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 Earle A. Chiles Research Institute, a division of
Providence Cancer Institute, at the Robert W. Franz Cancer Center,
in Portland, Ore.Providence Cancer Institute, a part of
Providence Health & Services, offers the latest in cancer
services, including diagnostic, treatment, prevention, education,
support and internationally-renowned research. The Earle A. Chiles
Research Institute, a division of Providence Cancer Institute, is a
world-class research facility located within the Robert W. Franz
Cancer Center. The Institute's main area of investigation is cancer
immunotherapy, a specialized field of study focused on triggering
the immune system to fight cancer. Visit
www.chilesresearch.org.
Forwarding 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 Galectin 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
clinical trials will lead to the first therapy for the treatment of
fatty liver disease with cirrhosis and those regarding the hope
that Galectin's lead compounds will be successful in connection
with cancer immunotherapy. Factors that could cause actual
performance to differ materially from those discussed in the
forward-looking statements include, among others, that Galectin may
not be successful in developing effective treatments and/or
obtaining the requisite approvals for the use of GR-MD-02 or any of
its other drugs in development; the Company's current clinical
trial in fibrotic liver disease and any future clinical studies 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, 2016,
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.
Contacts:Galectin
TherapeuticsLeigh
MinnierGregoryFCAleigh@gregoryfca.com610-228-2108
Providence Health & ServicesJean Powell
MarksJean.marks@providence.org503-215-6433
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