Leap Therapeutics Presents Nonclinical and Clinical Data on DKN-01 at AACR 2018 Annual Meeting
April 16 2018 - 9:00AM
Leap Therapeutics, Inc. (NASDAQ:LPTX) today presented nonclinical
and clinical data on DKN-01, Leap’s anti-DKK1 monoclonal antibody,
at the American Association for Cancer Research (AACR) 2018 Annual
Meeting. The presentation highlighted the immunomodulatory activity
of DKN-01 in nonclinical experiments and preliminary results from
the dose escalation phase of the clinical study evaluating DKN-01
in combination with the Merck (known as MSD outside the United
States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in
patients with advanced esophagogastric cancer.
Nonclinical Data:
Nonclinical studies demonstrated the activity of DKK1 inhibition
in enhancing innate immunity and the potential for combination with
immune checkpoint inhibitors. mDKN-01, the murine form of DKN-01,
reduced myeloid-derived suppressor cells (MDSCs), increased PD-L1
levels on MDSCs, and enhanced expression of T-cell
chemoattractants. These innate mechanisms, promoting an
inflammatory tumor microenvironment, are complementary to immune
checkpoint inhibition. In a syngeneic tumor model, mDKN-01 had
additive activity with anti-PD-1 therapy as compared to either
antibody administered alone.
Clinical Data:
Preliminary results from the dose escalation phase of the
clinical study evaluating the combination of DKN-01 and KEYTRUDA in
patients with advanced esophagogastric cancer demonstrated that the
combination was well tolerated with early signals of clinical
activity:
- Four out of five patients enrolled at the highest tested dose
of DKN-01 were naïve to anti-PD-1/PD-L1 therapy and evaluable for
response. One patient had a partial response with a 66% reduction
in target tumor volume. This patient had progressed on two prior
systemic therapies and had a tumor that was known to be KRAS
amplified, microsatellite stable (MSS), and PD-L1 negative; a
phenotype typically less responsive to anti-PD-1 therapy. Three
patients had stable disease, two of whom remain on study through at
least four cycles.
- Two patients enrolled in the escalation phase were refractory
to anti-PD-1/PD-L1 therapy and currently have had a best response
of stable disease. One of these patients also had a tumor that was
KRAS amplified, MSS, and PD-L1 negative and has been on study for
six cycles with an initial 10% reduction in tumor burden.
The DKN-01 and KEYTRUDA expansion combination continues to
enroll patients who are naïve to anti-PD-1/PD-L1 therapy (n=40) and
patients who are refractory to anti-PD-1/PD-L1 therapy (n=15).
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
cancer, biliary tract cancer, and gynecologic cancers, with an
emerging focus on patients with defined mutations of the Wnt
pathway and in combination 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
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:
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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