CAMBRIDGE, Mass., Jan. 14, 2019 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
announced an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the Perlmutter
Cancer Center at NYU Langone Health to study DKN-01, as a
monotherapy and in combination with docetaxel in patients with
advanced prostate cancer. This clinical trial is specifically
targeting a biomarker-selected patient population in metastatic
castration-resistant prostate cancer (mCRPC) with elevated
Dickkopf-1 (DKK1) levels.
"DKK1 can promote prostate cancer
growth through suppressing the anti-tumor immune response. We have
discovered that DKK1 is upregulated
in the substantial portion of advanced prostate cancers that lack
expression of androgen receptor," commented Dr. Wise. "Patients
with this type of prostate cancer have a very poor prognosis
and may benefit from this new immunotherapy strategy targeting
DKK1 therapy with DKN-01."
"An important part of our DKN-01 development strategy is to
target biomarker-selected patient populations," said Cynthia Sirard, M.D., Vice President, Clinical
Development of Leap Therapeutics. "In our esophagogastric cancer
study, we have identified DKK1 levels
measured by RNAScope as a potential predictor of response to
DKN-01-based therapy. We are looking forward to treating mCRPC
patients with elevated DKK1 levels in
this study, building on our and Dr. Wise's work."
The study is expected to begin enrolling patients in the first
quarter of 2019. mCRPC patients who have progressed on one or
more androgen receptor (AR) therapies (Xtandi or Zytiga) will be
screened for DKK1 elevation in their
plasma or in a tumor sample. Up to 97 patients will be enrolled in
a dose-escalation and then dose expansion cohorts. DKK1+ mCRPC
patients who have not received prior taxane chemotherapies will be
treated with DKN-01 and docetaxel. DKN-01 will be given as a
monotherapy to DKK1+ mCRPC patients who have progressed on or
refused docetaxel treatment.
About Prostate Cancer
Prostate cancer is the leading type of non-skin cancer in the
US, and the second leading cause of cancer worldwide. Approximately
1 in 9 men will be diagnosed with prostate cancer at some point in
their lives. Androgen receptor (AR)-targeted therapy can be
highly effective for the treatment of prostate cancer.
Unfortunately, most patients will eventually develop resistance and
progress to castration-resistant prostate cancer (CRPC), an
incurable form of the disease.
Disclosure
Dr. Wise is compensated to serve as a consulant to Leap
Therapeutics. Also, Dr. Wise's involvement in this upcoming study
does not constitute an institutional endorsement from NYU Langone
Health or its Perlmutter Cancer Center of the drug DKN-01 being
studied.
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://www.leaptx.com/investors.
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 Leap's
expectations with respect to the development and advancement of
DKN-01 and TRX518, including the initiation, timing, design and
results of future studies, enrollment in future studies, business
development, and other future expectations, plans and prospects.
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 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. 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:
Leap Therapeutics, Inc.
Douglas E. Onsi
Chief Financial Officer
donsi@leaptx.com
617-714-0360
Argot Partners
Investor Relations
Heather Savelle
212-600-1902
heather@argotpartners.com
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SOURCE Leap Therapeutics, Inc.