CAMBRIDGE, Mass., April 1, 2021 /PRNewswire/ -- Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced the
completion of enrollment for the first-line patient cohort in the
DisTinGuish study, a clinical trial evaluating Leap's
anti-Dickkopf-1 (DKK1) antibody,
DKN-01, in combination with tislelizumab, BeiGene Ltd.'s anti-PD-1
antibody, with or without chemotherapy, in patients with gastric or
gastroesophageal junction cancer (G/GEJ).
"The completion of enrollment for the first-line patients in the
DisTinGuish study is an important milestone for the DKN-01 and
tislelizumab combination development program," said Cynthia Sirard, M.D., Chief Medical Officer of
Leap Therapeutics. "In collaboration with our partner, BeiGene, we
are committed to realizing the potential of DKN-01 as part of a new
combination therapy with tislelizumab aimed at treating gastric and
gastroesophageal junction cancer patients, where a high global
unmet medical need remains."
The DisTinGuish trial (NCT04363801) is a Phase 2a,
nonrandomized, open-label, multicenter study of DKN-01 in
combination with tislelizumab with or without chemotherapy as
first-line or second-line therapy in adult patients with
inoperable, locally advanced G/GEJ adenocarcinoma. The study, which
will be conducted in two parts in the
United States and the Republic of Korea, includes up to 24
patients with first-line G/GEJ cancer and up to 48 patients with
second-line G/GEJ cancer whose tumors express high levels of
DKK1. Initial data is expected in the
second half of 2021. Leap is conducting this combination study as
part of an exclusive option and license agreement with BeiGene for
the development of DKN-01 in Asia
(excluding Japan), Australia, and New
Zealand. Leap retains exclusive rights for the development,
manufacturing, and commercialization of DKN-01 for the rest of the
world.
About gastric / gastroesophageal junction
cancer
Gastric adenocarcinoma (gastric cancer) remains one
of the most common and deadly cancers worldwide, especially among
older malesi. Based on GLOBOCAN 2018 data, stomach
cancer is the 5th most common neoplasm and the 3rd most deadly
cancer, with an estimated 783,000 deaths globally in
2018i. Ninety-five percent of cancers of the stomach are
adenocarcinomasi. Gastric cancer incidence and mortality
are highly variable by region and highly dependent on diet and
Helicobacter pylori infectioni. The gastroesophageal
junction (GEJ) is the area where the esophagus and stomach join
together. Given its anatomic location, GEJ adenocarcinomas have
often been grouped together with either esophageal or gastric
cancers in clinical trials.
About DKN-01
DKN-01 is a humanized monoclonal antibody
that binds to and blocks the activity of the Dickkopf-1
(DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and
PI3kinase/AKT signaling pathways, which have an important role in
tumor cell signaling and in mediating an immuno-suppressive tumor
microenvironment through enhancing the activity of myeloid-derived
suppressor cells and downregulating NK cell ligands on tumor
cells. The U.S. Food and Drug Administration has
granted DKN-01 Orphan Drug Designation for the treatment of gastric
and gastroesophageal junction cancer and Fast Track Designation in
combination with tislelizumab for the treatment of patients with
gastric and gastroesophageal junction adenocarcinoma whose tumors
express high DKK1 protein, following disease progression
on or after prior fluoropyrimidine- and platinum-containing
chemotherapy and if appropriate, human epidermal receptor growth
factor (HER2)/neu-targeted therapy.
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. DKN-01 is
in clinical trials in patients with esophagogastric, hepatobiliary,
gynecologic, and prostate cancers. Leap has entered into a
strategic partnership with BeiGene, Ltd. for the rights to develop
DKN-01 in Asia (excluding
Japan), Australia, and New
Zealand. For more information about Leap Therapeutics, visit
http://www.leaptx.com or view our public filings with the SEC that
are available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
FORWARD-LOOKING STATEMENTS FOR LEAP THERAPEUTICS
This
press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
Section 21E of the Securities Exchange Act of 1934, as amended, and
the Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. These statements include Leap's
expectations with respect to the development and advancement of
DKN-01, including the initiation, timing and design of future
studies, enrollment in future studies, potential for the receipt of
future option exercise, milestone, or royalty payments from
BeiGene, 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: that the initiation,
conduct, and completion of clinical trials, laboratory operations,
manufacturing campaigns, and other studies may be delayed,
adversely affected, or impacted by COVID-19 related issues; the
accuracy of our estimates regarding expenses, future revenues,
capital requirements and needs for financing; 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; 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 SEC, including Leap's Annual Report on
Form 10-K for the fiscal year ended December
31, 2020, as filed with the SEC on March 12, 2021 and as may be updated by Leap's
Quarterly Reports on Form 10-Q and the other reports Leap files
from time to time with the SEC. Any forward-looking statement
contained in this release speaks only as of its date. Leap
undertakes no obligation to update any forward-looking statement
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
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444111/
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