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Leap Therapeutics to Present Updated Data from Part A of the DisTinGuish Study of DKN-01 Plus Tislelizumab and Chemotherapy in Gastric Cancer Patients at the 2023 ASCO Annual Meeting Cambridge, MA

Key Takeaway: Leap Therapeutics is set to present updated long-term follow-up data from Part A of the DisTinGuish study at the 2023 ASCO Annual Meeting. This Phase 2 trial evaluates DKN-01 in conjunction with tislelizumab and chemotherapy for patients with advanced gastroesophageal adenocarcinoma. The presentation will provide insights into the efficacy of this therapeutic combination as a first-line treatment option. The ASCO Annual Meeting takes place from June 2-6, 2023, and will present findings from various parts of the study across multiple countries.

Market Sentiment Analysis

POSITIVE FACTORS

  • Leap Therapeutics is presenting long-term data which may offer new insights into treatment efficacy.
  • The study involves innovative combinations of therapies that may improve outcomes for gastric cancer patients.
  • Presentation at the prestigious ASCO Annual Meeting highlights the significance of the study.

Full Press Release Details

Leap Therapeutics to Present Updated Data from
Part A of the DisTinGuish Study of DKN-01
Plus Tislelizumab and Chemotherapy
in Gastric Cancer Patients at the 2023 ASCO
MA - April 26, 2023 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced that the Company will be presenting new long-term follow-up data in first-line
patients with advanced gastroesophageal adenocarcinoma (GEA) from Part A of the DisTinGuish study, a Phase 2 clinical trial evaluating
Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab and chemotherapy, at the upcoming 2023 American Society
of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL on June 2-6, 2023.
Leap Presentation Details:
A phase 2 study (DisTinGuish) of DKN-01 in combination with tislelizumab + chemotherapy as first-line (1L) therapy in patients
with advanced gastric or GEJ adenocarcinoma (GEA).
Samuel J. Klempner, Harvard Medical School
Type: Poster Discussion Session
Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
and Time: Monday, June 5, 2023, at 11:30 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, the Republic of Korea, the United Kingdom, and Germany. Part A enrolled 25 first-line HER2- GEA cancer patients to receive
DKN-01 in combination with tislelizumab and capecitabine and oxaliplatin. Part B enrolled 52 second-line GEA cancer patients whose
tumors expressed high levels of DKK1 to receive DKN-01 in combination with tislelizumab. Part C is enrolling approximately 160 first-line
HER2- GEA cancer patients in a randomized controlled trial of DKN-01 in combination with tislelizumab and chemotherapy compared to tislelizumab
About Leap Therapeutics
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. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with
gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information
about Leap Therapeutics, visit http://www.leaptx.com or view our public filings with the SEC that are available
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements
within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management
of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements.
The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will
be achieved. Words such as "anticipate," "expect," "project," "intend," "believe,"
"may," "will," "should," "plan," "could," "continue," "target,"
"contemplate," "estimate," "forecast," "guidance," "predict," "possible,"
"potential," "pursue," "likely," and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify forward-looking statements.
statements, other than historical facts, including statements regarding Part A of the DeFianCe trial; the anticipated timing
for the release of clinical data, and any outcomes of such trial; the potential, safety, efficacy, and regulatory and clinical progress
of Leap's product candidates; our future preclinical and clinical development plans in connection with our programs; and any assumptions
underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially
from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully
execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's clinical
trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or
any of its other programs; (iv) whether any Leap clinical trials and products will receive approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies; (v) exposure to inflation, currency rate and interest rate fluctuations,
as well as fluctuations in the market price of Leap's traded securities; (vi) whether the initiation, conduct, and completion
of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted
by ongoing COVID-19 related issues, global conflict or supply chain related issues; (vii) whether Leap's stockholders approve
the conversion of the Series X Non-Voting Convertible Preferred Stock; (viii) whether Leap's cash resources will be sufficient
to fund Leap's continuing operations; and (ix) Leap's ability to comply with the continued listing requirements of the
Nasdaq Global Market. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties.
No representations or warranties (expressed or Implied) are made about the accuracy of any such forward-looking statements. Leap may
not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking
statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to
those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the
SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any
forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives,
undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events
or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views
as of any date subsequent to the date hereof.
President & Chief Executive Officer
Leap Therapeutics, Inc.

Frequently Asked Questions

What is the DisTinGuish study about?

The DisTinGuish study evaluates DKN-01 combined with tislelizumab and chemotherapy for advanced GEA.

When will Leap Therapeutics present new data?

Leap will present updated data at the ASCO Annual Meeting from June 2-6, 2023.

Who is leading the presentation at ASCO?

Samuel J. Klempner from Harvard Medical School will lead the presentation.

How many patients participated in Part A?

Part A enrolled 25 first-line HER2- GEA patients.

What is DKN-01 targeting?

DKN-01 is a monoclonal antibody targeting the Dickkopf-1 (DKK1) protein.

Last updated: Apr 26, 2023