Leap Therapeutics Presents Non-clinical and Phase 1 Data for TRX518 and DKN-01 at the 2017 AACR Annual Meeting
03 April 2017 - 9:00PM
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, reported
non-clinical and clinical data for its GITR agonist antibody,
TRX518, and its Dickkopf-1 inhibitor antibody, DKN-01, at the 2017
American Association for Cancer Research (AACR) Annual Meeting.
TRX518 Data Presentation, Abstract Number:
CT018
Roberta Zappasodi, Ph.D., Research Scholar at
Memorial Sloan Kettering Cancer Center led an oral presentation
during the clinical trials plenary session titled “Intratumor and
peripheral Treg modulation as a pharmacodynamic biomarker of the
GITR agonist antibody TRX-518 in the first in-human trial.” Dr.
Zappasodi presented updated data on clinical biomarkers and the
mechanism of action of TRX518. The data were generated in the
Merghoub and Wolchok group in the Ludwig Collaborative, Parker
Institute and Swim Across America Lab at Memorial Sloan Kettering
Cancer Center. Taha Merghoub, Ph.D., is Associate Attending
laboratory member in the Melanoma and Immunotherapeutics Service
and Jedd Wolchok, M.D. Ph.D., is Chief of Melanoma and
Immunotherapeutics Service at Memorial Sloan Kettering Cancer
Center.
Data from the TRX518 Phase 1 trial showed that a
single-dose of TRX518 was associated with a reduction in
immunosuppressive regulatory T cells in patients’ tumors and in
circulating blood. Further analysis in donor blood samples in vitro
showed that TRX518 induces T-Bet upregulation and increases cell
death in regulatory T cells.
“These clinical data further demonstrate a
direct effect of GITR stimulation with TRX518 on human regulatory T
cells. As such, GITR stimulation may be an important therapeutic
tool to generate anti-tumor immunity, to be considered for future
immune therapy based combination trials,” said Dr. Merghoub.
About TRX518
TRX518 is a humanized monoclonal antibody with
agonist activity targeting glucocorticord-inducible TNF-superfamily
receptor (GITR). TRX518 is engineered to enhance immune responses
to cancer. TRX518 is being studied in two ongoing repeat-dose
clinical trials in patients with advanced solid tumor
malignancies.
DKN-01 Data Presentation, Abstract Number: 369
Data from the DKN-01 Phase 1 trial and
non-clinical data characterizing DKN-01 were also presented at the
conference in a poster session titled “Therapeutic targeting of the
Wnt antagonist DKK1 with a humanized monoclonal antibody in
oncology indications.” The poster included the characterization of
DKN-01’s binding epitope, data in animal models, and data
summarizing the clinical activity and biomarkers of DKN-01 in
cancer to-date.
About DKN-01
DKN-01 is a humanized monoclonal antibody that
binds to and blocks the action of the Dickkopf-1 (DKK1) protein, a
modulator of Wnt/Beta-catenin signaling. DKK1 expression has been
associated with poor prognosis in multiple cancers, and has been
implicated with increased tumor cell proliferation, metastasis, and
angiogenesis. Recent literature suggests DKK1 has an important role
in tumor cell signaling and in mediating an immuno-suppressive
tumor microenvironment. DKN-01 is being studied in clinical trials
in patients with esophageal, gastric, and biliary tract cancers.
DKN-01 has demonstrated single agent activity in non-small
cell lung cancer patients.
About Leap Therapeutics
For more information about Leap Therapeutics, visit
http://www.leaptx.com or our public filings with the SEC that are
available via EDGAR at http://www.sec.gov or via
http://www.investors.leaptx.com/.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. These statements include statements
relating to Leap’s expectations with respect to the development and
advancement of DKN-01, TRX518, and other programs, including the
initiation, timing and design of future studies, enrollment in
future studies, business development, and other future
expectations, plans and prospects. Leap has attempted to identify
forward looking statements by such terminology as ‘‘believes,’’
‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’
‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’
‘‘should,’’ or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements. Although
Leap believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from our
expectations. These risks and uncertainties include, but are not
limited to: the outcome, cost, and timing of our product
development activities and clinical trials; the uncertain clinical
development process, including the risk that clinical trials may
not have an effective design or generate positive results; our
ability to obtain and maintain regulatory approval of our drug
product candidates; our plans to research, develop, and
commercialize our drug product candidates; our ability to achieve
market acceptance of our drug product candidates; unanticipated
costs or delays in research, development, and commercialization
efforts; the applicability of clinical study results to actual
outcomes; the size and growth potential of the markets for our drug
product candidates; the accuracy of our estimates regarding
expenses, future revenues, capital requirements and needs for
financing; our ability to continue obtaining and maintaining
intellectual property protection for our drug product candidates;
and other risks. Detailed information regarding factors that may
cause actual results to differ materially will be included in Leap
Therapeutics’ periodic filings with the Securities and
Exchange Commission (the "SEC"), including Leap Therapeutics’
Form 10-K that Leap filed with the SEC on March 31, 2017. These
statements are only predictions and involve known and unknown
risks, uncertainties, and other factors. Any forward looking
statements contained in this release speak only as of its date. We
undertake no obligation to update any forward-looking statements
contained in this release to reflect events or circumstances
occurring after its date or to reflect the occurrence of
unanticipated events.
CONTACT
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360
Argot Partners
Susan Kim
212-203-4433
susan@argotpartners.com
or
Heather Savelle
617-663-4863
heather@argotpartners.com
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