Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
presented promising clinical data from the study evaluating DKN-01,
Leap’s anti-DKK1 monoclonal antibody, as a monotherapy in patients
with advanced esophagogastric cancer. In addition, Leap
announced that the first patient has been enrolled in the study
evaluating DKN-01 in patients with gynecological cancers. Leap also
announced two upcoming scientific presentations at the American
Association for Cancer Research (AACR) 2018 Annual Meeting.
DKN-01 Monotherapy in Patients with Esophagogastric CancerData
presented today at the Barclays Global Healthcare Conference
included 16 patients with advanced esophagogastric cancer who were
treated with DKN-01 monotherapy. Central imaging review
identified two patients (12.5%) with a best response of a partial
response and five patients (31.3%) with stable disease,
representing a total disease control rate of 43.8%. This cohort of
patients had received many different lines of prior therapy.
One patient who had failed prior investigational immunotherapies,
including a PD-L1 antagonist and IDO inhibitor, had a partial
response on DKN-01 monotherapy and remained on study for over a
year.
“The results of the DKN-01 monotherapy cohort demonstrate
promising single agent activity in a very difficult to treat
population of heterogeneous esophagogastric cancer. This data, in
addition to the encouraging activity we have seen with DKN-01 in
preclinical models and in patients in combination with
chemotherapy, provides a strong foundation for our ongoing study in
combination with the anti-PD-1 therapy Keytruda®,” commented
Cynthia Sirard, MD, Vice President of Clinical Development for
Leap.
DKN-01 Gynecologic Malignancies StudyLeap also announced that
the first patient has been dosed in a Phase 2 clinical trial
evaluating DKN-01 as a monotherapy and in combination with
paclitaxel chemotherapy in patients with advanced endometrioid
gynecologic malignancies. The study is part of Leap’s strategy to
treat cancer patients with documented mutations of the Wnt
signaling pathway, a biomarker identified in patients who have
responded to DKN-01 therapy. Data presented today by Leap
demonstrates that uterine cancer patients with these mutations
often have elevated intratumoral levels of DKK1.
“Mutations of the Wnt pathway, particularly beta-catenin, are
highly prevalent in endometrioid gynecologic cancers, and often
thought to be a driver of an aggressive subgroup of the disease,”
commented Michael Birrer, M.D., Ph.D., Director of the
Comprehensive Cancer Center at the University of Alabama at
Birmingham and an investigator on the study. “We are excited to
begin this trial of DKN-01, which has shown promising activity in
patients with Wnt signaling mutations in other solid tumor
malignancies."
The 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) or
endometrioid ovarian cancer (EOC). The study contains four groups
and is designed to evaluate the efficacy, safety, and
pharmacodynamics of DKN-01 monotherapy and combination therapy in
both EEC and EOC, with each group following a 2-stage Simon Minimax
design. The study will enroll approximately 94 patients, of which ~
50% will be required to have documented activating mutations of
beta-catenin or other Wnt signaling alterations.
Upcoming Presentation at AACR Annual MeetingAdditionally, Leap
announced two poster session presentations at the AACR Annual
Meeting, being held April 14 - 18, 2018, in Chicago, IL.
Abstract Number and Title: 1710 / 5 - DKN-01, a
therapeutic DKK1 neutralizing antibody, has immune modulatory
activity in nonclinical tumor modelsSession Title: Immune Response
to Therapies 2Session Date and Time: April 16, 2018, 8:00 AM -
12:00 PMSession Location: McCormick Place, Poster Section 32
Abstract Number and Title: 1699 / 24 - Treatment
with agonist anti-GITR antibody after chemotherapy enhances tumor
immunitySession Title: Immune Checkpoints 1Session Date and Time:
April 16, 2018, 8:00 AM - 12:00 PMSession Location: McCormick
Place, Poster Section 31
About Leap TherapeuticsLeap Therapeutics
(Nasdaq:LPTX) is 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 cancer, biliary tract cancer, and
gynecologic cancers, with an emerging focus on patients with
defined mutations of the Wnt pathway and in combinations with
immune checkpoint inhibitors. Leap’s second clinical candidate,
TRX518, is a novel, humanized GITR agonist monoclonal antibody
designed to enhance the immune system’s anti-tumor response that is
in two 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 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 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 Securities and Exchange
Commission (the "SEC"), including Leap Therapeutics’ Form 10-K
that Leap filed with the SEC on February 23, 2018. 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
CONTACT:
Douglas E. OnsiChief Financial OfficerLeap Therapeutics,
Inc.donsi@leaptx.com617-714-0360
Argot PartnersInvestor RelationsSusan Kim or Heather
Savelle212-600-1902susan@argotpartners.comheather@argotpartners.com
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