CAMBRIDGE, Mass., Sept. 24, 2020 /PRNewswire/ -- Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation to DKN-01 for the treatment of patients with gastric
and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors
express high Dickkopf-1 protein (DKK1), following disease progression on or after
prior fluoropyrimidine- and platinum- containing chemotherapy and
if appropriate, human epidermal receptor growth factor
(HER2)/neu-targeted therapy. DKN-01 is a humanized monoclonal
antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin
signaling.
The Fast Track program is intended to facilitate the development
and expedite the review of drug candidates and vaccines that treat
serious conditions and fill an unmet medical need. The purpose of
Fast Track is to get important new drugs to the patient earlier.
Programs with Fast Track designation may benefit from early and
frequent communication with the FDA, in addition to a rolling
submission of the marketing application. DKN-01 has also received
Orphan Drug Designation for the treatment of gastric and
gastroesophageal junction cancer from the FDA.
"We are pleased with the FDA's decision to grant Fast Track
designation for the development of DKN-01 to treat patients with
gastric and gastroesophageal junction cancer whose tumors
express high levels of DKK1,"
said Douglas E. Onsi, President and
Chief Executive Officer of Leap. "The designation highlights the
existing unmet medical need for new and effective treatments for
this patient population. We believe that DKN-01 shows promise as a
novel treatment option for
biomarker-selected patients with these cancers,
and this designation provides us with earlier and more frequent
opportunities to interact with the FDA during the development of
DKN-01."
DKN-01 is currently being evaluated in clinical trials for
gastroesophageal, gynecologic, hepatobiliary, and prostate cancers.
In September 2020, the first patient
was dosed in the Company's combination study of DKN-01 plus
tislelizumab, BeiGene, Ltd.'s anti-PD-1 antibody, in patients with
gastric or gastroesophageal junction cancer.
About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and
blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin
signaling, a signaling pathway frequently implicated in
tumorigenesis and suppressing the immune system. DKK1 has 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 ligands on tumor cells.
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 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 has entered into a collaboration 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
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, milestones 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, 2019, as filed with the SEC on March 16, 2020 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 statements
contained in this release speak only as of its date. Leap
undertakes 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
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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SOURCE Leap Therapeutics, Inc.