Leap Therapeutics Presents Biomarker Data from Clinical Study of DKN-01 in Combination with Paclitaxel in Esophageal Cancer
January 19 2017 - 3:30PM
Leap Therapeutics, Inc. reported updated clinical and biomarker
data from an ongoing study of DKN-01, a monoclonal antibody against
the Dickkopf-1 (DKK1) protein, in patients with cancer of the
esophagus and gastroesophageal junction. Data from the trial
identified genetic mutations that may be responsive to DKN-01
therapy, as well as decreased circulating immunosuppressive and
angiogenic markers that are consistent with the anticipated
mechanism of action of DKK1 inhibition. The data were presented
today by John Strickler, M.D., of the Duke University Medical
Center and an investigator on the trial, at the American Society
for Clinical Oncology Gastrointestinal Cancers Symposium.
Four of 19 patients evaluated with genetic testing were found to
have activating/stabilizing mutations of beta-catenin, which is a
molecule in the Wnt signaling pathway implicated in oncogenesis,
metastasis, and immune suppression. Of these 4 patients, 2 achieved
partial responses (PR) per RECIST v.1.1 and 1 had prolonged stable
disease. One patient has an ongoing response exceeding 20 months,
of which the past 9 months have been on DKN-01 monotherapy with
continued improvements in the disease.
“Wnt/beta-catenin signaling is often dysregulated in cancer,
leading to increased proliferation, metastasis, and immune
suppression. These early clinical results are encouraging and give
important insights into patient selection in these highly
aggressive cancers,” commented Dr. Strickler.
In the study to date, Leap has enrolled 44 patients with
advanced esophageal and gastroesophageal junction cancers who had
received between 1 and 7 prior lines of therapy. 10 of 41
evaluable patients achieved a PR and 15 patients achieved a best
overall response of stable disease, representing a total disease
control rate of 61%. Leap is continuing to enroll patients in this
study and has opened a new cohort specifically for patients with
gastric cancer with known Wnt pathway mutations.
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. 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
Leap Therapeutics’ most advanced clinical candidate, DKN-01, is
a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1)
protein. DKN-01 is in clinical trials in patients with
gastroesophageal cancer in combination with paclitaxel and in
patients with biliary tract cancers in combination with gemcitabine
and cisplatin. Leap’s second clinical candidate, TRX518, is a
novel, humanized GITR agonist monoclonal antibody designed to
enhance the immune system’s anti-tumor response. Leap has signed a
Merger Agreement with Macrocure Ltd (Nasdaq:MCUR) that is expected
to result in Leap becoming a public company that will trade on The
Nasdaq Global Market under the symbol “LPTX.” 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.
FORWARD LOOKING STATEMENTS
Some of the statements in this release are 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 relate to the
potential merger with Macrocure Ltd, future events of Leap’s
development of DKN-01, TRX518, and other programs, future
expectations, plans and prospects. Although Leap believes
that the expectations reflected in such forward-looking statements
are reasonable as of the date made, expectations may prove to have
been materially different from the results expressed or implied by
such forward-looking statements. Leap has attempted to
identify forward looking statements by terminology including
"believes," "estimates," "anticipates," "expects," "plans,"
"projects," "intends," "potential," "may," "could," "might,"
"will," "should," "approximately" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. 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
Joe Rayne
MacDougall Biomedical Communications
jrayne@macbiocom.com
781-235-3060
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