CAMBRIDGE, Mass., Sept. 17, 2019 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq: LPTX) today announced an oral and
poster presentation of updated clinical data from its ongoing Phase
2 clinical trial of DKN-01, its anti-Dickkopf-1 (DKK1) antibody, as both a monotherapy and in
combination with paclitaxel chemotherapy in patients with advanced
gynecological malignancies will be presented at the 2019
International Gynecologic Cancer Society Annual Global Meeting
taking place September 19-21, 2019 in
Rio de Janeiro, Brazil. The poster
will be presented on Friday, September
20 at 6:15 p.m. (BRT).
"We are very enthusiastic about the single agent and combination
activity of DKN-01 observed in this heavily pre-treated patient
population. DKN-01 targets DKK1,
which is a modulator of Wnt signaling. In this study, patients with
Wnt activating mutations and high levels of DKK1 have had clinical benefit and prolonged
progression-free survival (PFS)," commented Rebecca C. Arend, M.D., Department of Obstetrics
and Gynecology at the University of Alabama at
Birmingham School of Medicine, who presented the data on
behalf of the study group. "A monotherapy complete response and the
correlation of patient outcomes with prevalent tumor biomarkers are
impressive signals of activity in these patients, who have poor
prognosis and few treatment options."
Key Findings from the P204 Study include:
- DKN-01 single agent complete response:
Following the data cut-off date, one patient with Wnt signaling
alterations has had her monotherapy partial response deepen into a
complete response. She has remained on DKN-01 monotherapy for 14
months after enrolling in July 2018
and having a partial response after cycle 8. This represents the
first complete response for a patient on DKN-01 monotherapy.
- Patients with Wnt activating mutations have longer
PFS: Across the study, patients with Wnt activating
mutations have demonstrated a longer PFS (n=21, 175 days) as
compared to patients without Wnt activating mutations (n=67, 63
days). The benefit observed in patients with Wnt activating
mutations was statistically maintained regardless of treatment type
(monotherapy or combination therapy) and cancer type (endometrial
or ovarian cancer).
- Patients with DKK1-high
tumors have longer PFS: DKK1 expression as measured by in situ
hybridization RNAscope assay is currently available for 54 of the
patients on the study, and 13 patients (24.1%) were identified as
DKK1-high tumoral expression. Similar
to the results from Leap's study in patients with esophagogastric
cancer, patients whose tumors are DKK1-high have prolonged PFS (n=13, 168 days) as
compared to patients with tumors that are DKK1-low (n=41, 63 days). The benefit observed in
patients with DKK1-high tumors was
statistically maintained regardless of monotherapy or combination
therapy treatment and cancer type (endometrial or ovarian
cancer).
- Few survival events in Wnt activating mutation or
DKK1-high populations: Median
overall survival (OS) has not yet been reached for the patients
with Wnt activating mutations as compared to 321 days OS for
patients without Wnt activating mutations. Only 3 of 21 patients
with Wnt activating mutations (14.3%) have had events as compared
to 18 of 67 patients (26.9%) without Wnt activating mutations.
Median OS has also not been reached for the DKK1-high patients as compared to 365 days for
the patients who are DKK1-low. Only 2
of 13 DKK1-high patients (15.4%) have
had events as compared to 12 of 41 (29.3%) DKK1-low patients. Patient follow-up remains
ongoing.
About the P204 Study
The P204 study is a Phase 2
basket study evaluating DKN-01 as a monotherapy and in combination
with paclitaxel in patients with relapsed/refractory endometrioid
endometrial cancer (EEC), endometrioid ovarian cancer (EOC) or
carcinosarcoma. Ninety-two patients have been enrolled in the first
four groups that were designed to evaluate the efficacy, safety,
and pharmacodynamics of DKN-01 monotherapy and combination therapy
in both EEC and EOC. The study has been expanded to include DKN-01
monotherapy and paclitaxel combination cohorts in patients with
carcinosarcoma. Approximately fifty percent (50%) of patients
in each cohort were required to have Wnt pathway alterations, which
included Wnt activating mutations and Wnt signaling mutations.
Additional patient follow-up is expected in the first half of
2020.
About DKN-01
DKN-01 is a humanized monoclonal antibody
that binds to and blocks the activity of the Dickkopf-1
(DKK1) protein, a modulator of
Wnt/Beta-catenin signaling, a signaling pathway frequently
implicated in tumorigenesis and suppressing the immune system.
DKK1 has an important role in tumor
cell signaling and in mediating an immuno-suppressive tumor
microenvironment through enhancing the activity of myeloid-derived
suppressor cells and downregulating NK ligands on tumor
cells.
About Leap Therapeutics
Leap Therapeutics (Nasdaq:
LPTX) is focused on developing targeted and immuno-oncology
therapeutics. Leap's most advanced clinical candidate, DKN-01, is a
humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01
is in clinical trials in patients with esophagogastric,
hepatobiliary, gynecologic, and prostate cancers. Leap's second
clinical candidate, TRX518, is a humanized GITR agonist monoclonal
antibody designed to enhance the immune system's anti-tumor
response that is in advanced solid tumor studies. 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 https://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 regarding
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 known and unknown risks, uncertainties and other factors
that could cause actual results to differ materially from our
expectations. Such risks and uncertainties include, but are not
limited to: the accuracy of our estimates regarding expenses,
future revenues, capital requirements and needs for financing; the
ability to complete a financing or form business development
relationships to fund our expenses; 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; 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 SEC, including Leap's Annual Report on Form 10-K for the
fiscal year ended December 31, 2018,
as filed with the SEC on April 1,
2019, and Quarterly Report on Form 10-Q for the quarter
ended March 31, 2019, as filed with
the SEC on May 15, 2019, and for the
quarter ended June 30, 2019, as filed
with the SEC on August 10,
2019. 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.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
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