Leap Therapeutics to Present Preclinical Data of FL-501, a Novel GDF-15 Neutralizing Antibody, at the AACR 2025 Annual Meeting
Rhea-AI Summary
Leap Therapeutics (NASDAQ:LPTX) announced preclinical data presentation for FL-501, their novel GDF-15 neutralizing antibody, at the AACR 2025 Annual Meeting in Chicago. FL-501 shows promise in treating cancer cachexia, a life-threatening condition characterized by weight loss and muscle wasting.
Key findings demonstrate that FL-501 exhibited a 2-3-fold longer half-life and 50% reduced clearance compared to its wild-type precursor and ponsegromab in humanized FcRn mouse studies. The antibody successfully restored body composition in mouse cachexia models and effectively countered cisplatin-induced weight loss in non-small cell lung cancer patient-derived xenograft models.
The company plans to advance FL-501 into clinical trials in 2026, positioning it as a potential best-in-class treatment option for cancer cachexia, a condition currently lacking effective treatments.
Positive
- Demonstrated 2-3x longer half-life and 50% reduced clearance compared to competitors
- Successfully restored body composition in preclinical models
- Effective against cisplatin-induced weight loss in cancer models
- Addresses unmet medical need in cancer cachexia treatment
Negative
- Clinical trials not starting until 2026
- Currently only preclinical data available
- No proven efficacy in humans yet
News Market Reaction – LPTX
In the trading session that priced this news, LPTX gained 1.73%, reflecting a mild positive market reaction.
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FL-501 fully restored body composition and reversed key indicators of cachexia in preclinical models
Findings confirm GDF-15's role in cachexia and support advancing FL-501 into the clinic
FL-501 is a potential best-in-class monoclonal antibody targeting growth differentiation factor 15 (GDF-15), a cytokine that is implicated in multiple diseases and therapeutic areas, including cancer cachexia.
"Cancer cachexia is a devasting and potentially life-threatening condition characterized by significant weight loss, muscle wasting, fatigue, and severely reduced quality of life. It is a major contributor to cancer-related mortality, and unfortunately there are no effective treatment options available to patients," said Jason Baum, PhD, Chief Scientific Officer of Leap. "These data not only demonstrate that FL-501 is a novel and potential best-in-class anti-GDF-15 antibody, but also capable of fully restoring body composition in preclinical models that is comparable or better than other, clinical-stage antibodies. We look forward to progressing the development of FL-501 and bringing the asset into the clinic in 2026."
Key Findings:
- In humanized FcRn mouse studies, FL-501 demonstrated a 2-3-fold longer half-life and
50% reduced clearance compared to its wild-type precursor and ponsegromab - In mouse cachexia models using GDF-15-overexpressing colorectal cancer cells, FL-501 fully restored body composition, comparably or better than clinical-stage antibodies visugromab and ponsegromab
- In a non-small cell lung cancer patient-derived xenograft model, FL-501 effectively countered cisplatin-induced weight loss, restoring body weight, composition, and condition scores
- These findings confirm GDF-15's role in cachexia and support FL-501's advancement in development
Poster Details:
Title: FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical models
Presenter: Roma Kaul, PhD, Leap Therapeutics
Session Category: Experimental and Molecular Therapeutics
Session Title: New and Emerging Cancer Drug Targets
Date and Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CT
Poster Board Number: 15
Published Abstract Number: 4258
About FL-501
FL-501 is a potential best-in-class monoclonal antibody in preclinical development that targets growth differentiation factor-15 (GDF-15), a cytokine that is produced at elevated levels in response to various stresses, including chronic inflammation, obesity, cardiovascular diseases, cancers, and chemotherapy treatment. High GDF-15 expression is associated with cancer cachexia including loss of appetite, nausea and weight loss. FL-501 was engineered for higher affinity to GDF-15 and longer plasma half-life compared to competing therapies. In addition to cachexia, FL-501 may be able to reverse immunosuppression in cancers where elevated GDF-15 is correlated with poor survival, as well as play a role in treating other GDF-15-related diseases. FL-501 is being developed through a collaboration agreement with Adimab.
About Leap
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (
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; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; 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) the results of Leap's clinical trials and pre-clinical studies, including the final data from Part B of the DeFianCe study and additional preclinical data for FL-501, (ii) Leap's ability to successfully finance or enter into new strategic partnerships for sirexatamab or FL-501; (iii) any regulatory feedback that Leap may receive from
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
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SOURCE Leap Therapeutics, Inc.