Full Press Release Details
Leap Therapeutics Announces Oprhan Drug
Designation of DKN-01
for the Treatment of Gastric and Gastroesophageal
Cambridge, MA - June 11, 2020
- 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 the Company orphan drug designation for DKN-01 for
the treatment of gastric and gastroesophageal junction cancer. 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.
"Orphan Drug Designation for DKN-01
in gastric and gastroesophageal junction cancer is another significant milestone in our DKN-01 development program and underscores
the need for new treatment options for these indications," said Douglas E. Onsi, President and Chief Executive Officer of
Leap. "We believe DKN-01 has the potential to be an important new therapy for this patient population that remains an area
of high unmet medical need."
The FDA's Office of Orphan Drug Products
grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer
than 200,000 people in the U.S. Orphan drug designation provides to Leap certain benefits, including market exclusivity upon regulatory
approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.
DKN-01 is currently being evaluated in
Phase 1/2 and Phase 2 clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers. Site initiation activities
are now underway for 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 with dosing of the first patients expected in the third quarter of
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 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 formed a 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
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 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 we file from time to time with the SEC.
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.
President & Chief Executive Officer
Leap Therapeutics, Inc.