Full Press Release Details
Leap Therapeutics to Present Updated
Data for DKN-01 Monotherapy and Paclitaxel Combination
In Gynecologic Cancers
Enhanced Survival Outcomes Achieved in Patients with Wnt Activating Mutations and DKK1-high Tumors
DKN-01 Monotherapy Treated Endometrial Cancer Patient Maintains a Complete Response
Responses Observed in Carcinosarcoma Patients Treated with DKN-01 Plus Paclitaxel Combination
Conference Call and Webcast to be Held April 23, 2020 at 8:30 A.M. EDT
Cambridge, MA - April 23, 2020
- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics,
today announced updated clinical data from its ongoing Phase 2 clinical trial of DKN-01, its anti-Dickkopf-1 (DKK1) antibody, as
both a monotherapy and in combination with paclitaxel chemotherapy in patients with advanced gynecological malignancies. Leap will
host a conference call with Rebecca Arend, M.D., Assistant Professor and Associate Scientist, Gynecologic Oncology Clinic, The
University of Alabama at Birmingham School of Medicine Comprehensive Cancer Center Experimental Therapeutics Program, today, April
23, 2020, at 8:30 A.M. EDT to discuss the data.
"We are seeing clinically meaningful
monotherapy activity of DKN-01 in heavily pre-treated endometrial cancer and carcinosarcoma populations, including a complete response,
a partial response, and durable tumor reductions in many patients. In combination with paclitaxel, DKN-01 is generating durable
responses and disease control in paclitaxel-experienced patients," said Dr. Arend.
"This study also demonstrates the
importance of mechanism of action based biomarkers for DKN-01 therapy, as patients with high tumor DKK1 expression or Wnt activating
mutations had enhanced progression-free survival and overall survival. These biomarkers should be the foundation for additional
DKN-01 studies in endometrial and carcinosarcoma patients, as monotherapy and in combination with other active agents," continued
The P204 Study in Gynecologic Cancers
The P204 study is a Phase 2 basket study
evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory epithelial endometrial
cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (also known as Malignant Mixed Mullerian Tumor (MMMT)). As of
the cut-off date of December 30, 2019, 105 heavily pretreated patients had been enrolled across the six groups of the study. Approximately
67% of all patients had tumors with identified Wnt pathway alterations, which included approximately 20% with Wnt activating mutations.
Patients with EEC and carcinosarcoma had higher tumor DKK1 expression and a higher percentage of Wnt activating mutations than
the ovarian cancer patients. Patients whose tumors had Wnt activating mutations expressed 15 times higher levels of tumoral DKK1.
Key Findings from the P204 Study
Conference Call Details:
U.S. Dial-in Number: (866) 589-0108
International Dial-in Number: (409) 231-2048
Conference ID: 1190677
The presentation will be webcast live
and may be accessed on the Investors page of the company's website at https://investors.leaptx.com/, where the presentation
slides and a replay of the event will also be available for a limited time.
About Gynecological Cancers
There are numerous forms of gynecologic
cancers, but two of the most prevalent types are cancers of the uterus or ovaries. According to the National Cancer Institute,
there are more than 61,000 patients diagnosed with uterine cancer. There are currently very few post-surgical treatment options
for these patients, typically consisting of chemotherapy, local radiation therapy, and hormonal agents, and poor treatment outcomes.
Patients with endometrial cancers have a high frequency of mutations in a protein known as beta-catenin, with alterations estimated
at approximiately 30% of cases by The Cancer Genome Atlas. These beta-catenin mutations are often driver mutations leading to rapid
disease progression and poor outcomes. Carcinosarcoma, or Malignant Mixed Mullerian Tumor, is a uterine cancer comprised of carcinoma
and sarcoma cells and accounts for less than five percent of all uterine cancer. Carcinosarcoma is an aggressive tumor with poor
patient prognosis and poor response to chemotherapy.
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 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, 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.
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.
Leap Therapeutics, Inc.