- DKN-01 in combination with gemcitabine
and cisplatin generated a 33% Objective Response Rate and 95%
disease control rate
Leap Therapeutics, Inc. today announced the presentation of
top-line data from its clinical trial of DKN-01 combination therapy
in patients with cholangiocarcinoma at the European Society for
Medical Oncology 2016 Congress (ESMO 2016) in Copenhagen, Denmark.
Lipika Goyal, MD, of Massachusetts General Hospital, an
investigator on the study, presented a poster entitled “Phase I
study of DKN-01, an anti-DKK1 monoclonal antibody, in combination
with gemcitabine and cisplatin in patients with advanced biliary
cancer.” DKN-01 is a humanized monoclonal antibody targeting
Dickkopf-1 (DKK1), a secreted protein that modulates cell signaling
of the Wnt pathways and that promotes an immunosuppressive tumor
microenvironment. Published studies have indicated that DKK1
expression levels are elevated in patients with cholangiocarcinoma
and associated with worse overall survival.
The two-part open-label, dose-escalating study enrolled 27
patients with cholangiocarcinoma who were treated with DKN-01 in
combination with gemcitabine and cisplatin. In Part A, patients
received DKN-01 at either 150 (n=4) or 300 mg (n=3) with 1000 mg/m2
of gemcitabine and 25 mg/m2 of cisplatin on days 1 and 8 of each
21-day cycle. The Part B expansion portion of the study evaluated
the 300 mg dose of DKN-01 in combination with gemcitabine and
cisplatin in 20 additional patients. The primary objective of this
study was to evaluate the safety, pharmacokinetics, and efficacy of
DKN-01 in combination with gemcitabine and cisplatin in
treatment-naïve and previously-treated patients.
Data from the study showed that DKN-01 in combination with
gemcitabine and cisplatin was well tolerated and safe at each dose
level. There were no DKN-01 reported related serious adverse events
or dose limiting toxicities. At the selected 300 mg DKN-01 dose
level, 7 of 21 evaluable patients (33%) experienced a partial
response and 20 patients experienced a partial response or stable
disease, representing a disease control rate of 95%. The median
progression-free survival and overall survival have not yet been
reached, as many patients remain on study receiving therapy.
“Patients with advanced cholangiocarcinoma have no approved
therapies beyond standard gemcitabine/cisplatin chemotherapy and
desire better clinical outcomes. These early but promising results
from the ongoing single arm study of DKN-01 in combination with
gemcitabine and cisplatin demonstrate the potential of DKN-01 in
aggressive cancers, such as cholangiocarcinoma, and provide a
strong rationale for further clinical development,” commented
Andrew Zhu, MD, of Massachusetts General Hospital, an investigator
in the study and co-author on the poster.
About CholangiocarcinomaCholangiocarcinoma is a cancer
that starts in the bile duct, a thin tube about 4 to 5 inches long
that reaches from the liver to the small intestine. The major
function of the bile duct is to move a fluid called bile from the
liver and gallbladder to the small intestine, where it helps digest
the fats in food. The Cholangiocarcinoma Foundation estimates that
approximately 6,000 patients will be diagnosed with
cholangiocarcinoma in the United States each year, with
publications estimating that nearly 200,000 patients are diagnosed
worldwide each year. The majority of cholangiocarcinoma cases are
diagnosed with advanced stage disease with a 5-year survival rate
of less than 10%. The standard treatment option for advanced
patients is systemic chemotherapy and supportive care.
About DKN-01DKN-01 is a humanized IgG4 monoclonal
antibody with neutralizing activity against the Dickkopf-1 (DKK1)
protein. High levels of DKK1 expression has been associated with
poor prognosis in multiple cancers, and DKK1 has a critical role in
mediating Wnt signaling pathways and maintaining an
immunosuppressive tumor microenvironment. DKN-01 is currently being
studied in clinical trials in esophageal cancer and
cholangiocarcinoma. DKN-01 additionally demonstrated single agent
activity in NSCLC in a Phase 1 dose escalation study.
About Leap TherapeuticsLeap Therapeutics is an
immuno-oncology company with two clinical stage programs. Leap’s
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 esophageal cancer in combination
with paclitaxel and in patients with cholangiocarcinoma 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) which is expected to result in Leap becoming a
public company. For more information about Leap Therapeutics or the
merger with Macrocure, visit http://www.leaptx.com or our public
filings with the SEC that are available via EDGAR at
http://www.sec.gov.
FORWARD LOOKING STATEMENTSSome of the statements in this
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1934Subject Company: Leap Therapeutics, Inc.Commission File
Number: 333-213794
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version on businesswire.com: http://www.businesswire.com/news/home/20161008005008/en/
Leap TherapeuticsDouglas E. Onsi, 617-714-0360Chief Financial
Officerdonsi@leaptx.com