Full Press Release Details
Leap Therapeutics to Present Updated Data from
the DisTinGuish Study of DKN-01 Plus Tislelizumab and
Preclinical Data in Colorectal Cancer Models
at the SITC Annual Meeting
55% ORR, 73% DCR, and 7.7 month PFS in DKK1-high/PD-L1-high
second-line gastric cancer patients
DKN-01 also demonstrated preclinical tumor
regression data in CRC models supporting ongoing clinical trial
Cambridge, MA - November 7, 2022
- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics,
today announced the Company will be presenting updated data from Part B of the DisTinGuish study evaluating DKN-01 in combination
with tislelizumab, BeiGene's anti-PD-1 antibody, in second-line gastroesophageal adenocarcinoma (GEA) cancer patients whose tumors express
high levels of DKK1 (DKK1-high) at the Society of Immunotherapy for Cancer (SITC) 37th Annual Meeting being held in Boston, MA on November 8-12,
Leap is also presenting preclinical DKN-01 data
supporting the DeFianCe study, a Phase 2 study of DKN-01 in combination with bevacizumab and standard of care chemotherapy in patients
with advanced colorectal cancer (CRC) who have received one prior systemic therapy.
"The combination of DKN-01 plus tislelizumab
continues to demonstrate a well-tolerated and active combination in previously treated, DKK1-high, anti-PD-1/PD-L1 na ve GEA cancer
patients," said Samuel Klempner, MD, Associate Professor at Harvard Medical School who leads the gastric and esophageal cancer program
at Massachusetts General Hospital Cancer Center and is a principal investigator on the DisTinGuish study. "In Keynote-061, anti-PD-1
monotherapy generated a 2% ORR in second-line GEA patients with PD-L1 expression combined positive score (CPS) < 1 and a 24.5% ORR
in patients with CPS > 10. As DKK1-high patients appear to have more aggressive disease, the updated second-line DKN-01 plus
tislelizumab Part B data provides further evidence of activity in this difficult-to-treat patient population, particularly among
the DKK1-high/PD-L1-high patients. These results continue to support the decision to start Part C, the randomized controlled clinical
trial in first-line patients."
"The preclinical results in CRC models
showed impressive monotherapy and chemotherapy combination activity in multiple xenograft models, including those that are resistant
to 5-FU treatment, which is commonly used to treat metastatic disease," said Cynthia Sirard, MD, Chief Medical Officer of Leap
Therapeutics. "Colorectal cancer is the third most frequent cancer globally and the second leading cause of death. We enrolled
our first patient in the Phase 2 DeFianCe study in October evaluating DKN-01 in combination with standard of care bevacizumab and
chemotherapy as a second-line treatment for patients with CRC and look forward reporting initial data in mid-2023."
Key Findings DisTinGuish
Key Findings Preclinical CRC
Leap Poster Details:
Title: DKN-01 and Tislelizumab as a Second-line
(2L) Investigational Therapy in Advanced DKK1-high Gastroesophageal Adenocarcinoma (GEA): DisTinGuish Trial
First Author: Samuel
J. Klempner, Harvard Medical School
Session Category: Poster Session
Session title: Immune-stimulants and immune
Date and time: Thursday, November 10,
2022, at 9:00 a.m. ET
Title: DKN-01 Demonstrates Immune Modulatory
Activity and Robust Efficacy in Colorectal Cancer Models
First Author: Michael Haas, Leap Therapeutics
Session Category: Poster Session
Session title: Immune-stimulants and immune
Date and time: Thursday, November 10,
2022, at 9:00 a.m. ET
About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is
a Phase 2 study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line
therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in three parts in the United
States and the Republic of Korea. Part A has been completed with 25 first-line HER2- GEA cancer patients whose tumors express either
high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B has completed enrolling patients with second-line DKK1-high
GEA cancer. Part C of the study is enrolling approximately 160 first-line patients in a randomized controlled trial of DKN-01 in
combination with tislelizumab and chemotherapy compared to tislelizumab and chemotherapy. Leap is conducting this combination study as
part of an exclusive option and license agreement with BeiGene.
About the DeFianCe Study
The DeFianCe study (NCT05480306) is a
Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients
with advanced CRC who have received one prior systemic therapy. The study is designed with an initial 20 patient cohort and to then expand
into a 130-patient randomized controlled trial against bevacizumab and standard of care chemotherapy.
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 being developed in patients with esophagogastric, gynecologic, and colorectal cancers.
Leap has entered into a strategic 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 clinical 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, global conflict or supply chain related issues; unstable global market and
economic conditions; 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 is 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, 2021, as filed with the SEC on
March 11, 2022 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.
President & Chief Executive Officer
Leap Therapeutics, Inc.