Leap Therapeutics Presents Positive DKN-01 Clinical Data in Biliary Tract Cancers at American Society of Clinical Oncology (A...
May 17 2017 - 5:17PM
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
reported interim data from the Phase 1 study of DKN-01 in
combination with standard of care chemotherapy in patients with
advanced biliary tract cancers. Data from the study was published
online as an abstract in advance of a poster presentation being
held at the American Society of Clinical Oncology (ASCO) Annual
Meeting held June 2 - 6, 2017 in Chicago, Illinois.
“These data combining DKN-01 with gemcitabine
and cisplatin are highly encouraging and provide a strong rationale
for advanced clinical development. Biliary tract cancer is an
aggressive disease with a poor prognosis and for which there are
limited treatment options. First-line chemotherapy studies
have reported response rates of 20% to 25%, progression-free
survival of 5.6 to eight months, and overall survival of 11 to 12
months,” commented Jennifer Eads, MD, of the University Hospitals
Siedman Cancer Center at Case Western Reserve University and an
investigator on the study.
Data from the study showed that DKN-01 in
combination with gemcitabine and cisplatin was well tolerated with
no new emerging safety trends. At the selected 300 mg DKN-01
dose level, seven of 22 patients (31.8%) experienced a partial
response and 21 patients experienced a partial response or stable
disease, representing a disease control rate of 95.5%. The
preliminary median progression-free survival was 9.4 months, and
the median overall survival was not yet reached. The median number
of cycles of DKN-01 was eight (range of one to 17), and the median
duration on study was 206 days. Eight patients were still on
therapy as of the time of data cut-off.
“This study suggests that DKN-01 shows activity
in combination with gemcitabine and cisplatin. Results so far look
promising, and further evaluation of its additional benefit over
standard of care chemotherapy in patients with biliary tract cancer
is warranted,” commented Juan Valle MB ChB MSc FRCP, Professor of
Medical Oncology in the University of Manchester (Institute of
Cancer Studies) and primary investigator of the landmark Phase 3
ABC-02 study evaluating gemcitabine and cisplatin for the treatment
of advanced biliary tract cancers.
“We are encouraged by the impressive durable
responses in patients with advanced biliary tract cancer,” said
Christopher K. Mirabelli, Ph.D., Chief Executive Officer of Leap
Therapeutics. “We have recently expanded the study to enroll an
additional 20 patients to further characterize the patients that
respond to DKN-01 combination therapy. Based on the safety and
efficacy profile seen to date, we are aggressively moving DKN-01
forward in biliary tract cancer, genetically-defined patient
populations in gastric, liver, and uterine cancers, and soon in
combination with checkpoint inhibitors.”
About the StudyThe open-label,
dose-escalation study enrolled 27 patients with treatment-naïve
advanced biliary tract cancer. Patients received one of two dose
levels (150 mg or 300 mg) of DKN-01 in combination with gemcitabine
and cisplatin during Part A, with 20 additional patients treated at
300 mg dose level of DKN-01 in the Part B expansion cohort. The
primary objective of this study is to evaluate the safety,
pharmacokinetics, and efficacy of DKN-01 in combination with
gemcitabine and cisplatin.
Leap Poster Presentation
DetailsAbstract Number: 4075Title: “A phase I study
of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination
with gemcitabine (G) and cisplatin (C) in patients (pts) for
first-line therapy with advanced biliary tract cancer
(BTC).”Session Title: Poster Session: Gastrointestinal
(Noncolorectal) CancerDate: June 3, 2017Time: 8:00AM-11:30AM
Central Time
About Leap TherapeuticsLeap
Therapeutics’ (NASDAQ:LPTX) 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, alone and in combination with paclitaxel,
and in patients with biliary tract cancer, in combination with
gemcitabine and cisplatin. An investigator-initiated study of
DKN-01 will be conducted in hepatocellular carcinoma patients, in
combination with sorafenib. DKN-01 has demonstrated single
agent activity in non-small cell lung cancer patients. 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 monotherapy 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 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
Leap Therapeutics (NASDAQ:LPTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Leap Therapeutics (NASDAQ:LPTX)
Historical Stock Chart
From Sep 2023 to Sep 2024