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Leap Therapeutics to Present Final Clinical Data from Part B of the DeFianCe Study at the ESMO Congress 2025

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Leap Therapeutics (NASDAQ:LPTX) announced it will present final clinical results from Part B of the DeFianCe Phase 2 study at the ESMO Congress 2025. The study evaluates sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, combined with bevacizumab and chemotherapy versus a control arm in advanced microsatellite stable (MSS) colorectal cancer patients.

The presentation will be delivered by Dr. Zev A. Wainberg from UCLA in a Mini Oral Session on October 19, 2025 at 4:05 p.m. CEST in Berlin, Germany. The study focuses on second-line therapy for MSS colorectal cancer patients who have received one prior systemic therapy.

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On the day this news was published, LPTX gained 12.63%, reflecting a significant positive market reaction. Argus tracked a peak move of +23.2% during that session. Our momentum scanner triggered 24 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $16M at that time. Trading volume was exceptionally heavy at 10.6x the daily average, suggesting very strong buying interest.

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CAMBRIDGE, Mass., Sept. 25, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced it will present the final clinical results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease. The final results will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany.

Mini Oral Session Details:

Title: DeFianCe Trial: A randomized phase 2 trial of sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus bevacizumab and chemotherapy as second-line therapy in advanced microsatellite stable (MSS) colorectal cancer (CRC)
Presenter: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of the GI Oncology Program at UCLA
Session Type: Mini Oral Session  
Session Category: GI Tumours, Lower Digestive
Date and Time: Sunday, October 19, 2025, 4:05 p.m. CEST
Location: Cologne Auditorium – CityCube A
Abstract Number: LBA34

About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's pipeline includes sirexatamab (DKN-01), a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, and FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein. 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 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.

All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates, including sirexatamab and FL-501; Leap's plan to reduce clinical and operational activities, reduce spending and conserve cash, explore strategic alternatives to preserve and maximize shareholder value, including by leveraging its cash balance and potentially selling or partnering sirexatamab or FL-501; 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 sell or enter into partnerships for sirexatamab or FL-501; (ii) the cost and timeline to complete the DeFianCe Study and wind-down operations; (iii) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency or from site institutional review boards; and (iv) the availability of strategic alternatives that would preserve or generate any shareholder value. 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 a 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.

CONTACT:

Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com 

Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com

Leap Therapeutics logo (PRNewsfoto/LEAP Therapeutics)

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/leap-therapeutics-to-present-final-clinical-data-from-part-b-of-the-defiance-study-at-the-esmo-congress-2025-302566702.html

SOURCE Leap Therapeutics, Inc.

FAQ

What will Leap Therapeutics (LPTX) present at ESMO Congress 2025?

Leap Therapeutics will present the final clinical results from Part B of the DeFianCe Phase 2 study, evaluating sirexatamab combination therapy versus control in advanced MSS colorectal cancer.

When and where will LPTX present the DeFianCe study results?

The results will be presented on Sunday, October 19, 2025, at 4:05 p.m. CEST in the Cologne Auditorium – CityCube A at the ESMO Congress in Berlin, Germany.

What is sirexatamab (DKN-01) and how is it being studied by LPTX?

Sirexatamab is an anti-DKK1 monoclonal antibody being studied in combination with bevacizumab and chemotherapy for second-line treatment of advanced microsatellite stable colorectal cancer.

Who will present Leap Therapeutics' DeFianCe trial results at ESMO 2025?

Dr. Zev A. Wainberg, Professor of Medicine and Co-Director of the GI Oncology Program at UCLA, will present the results in a Mini Oral Session.
Leap Therapeutic

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