FL-501 fully restored body composition and reversed key indicators of cachexia in preclinical models

FL-501在临床前模型中完全恢复了身体组成，并逆转了恶病质的关键指标。

Findings confirm GDF-15's role in cachexia and support advancing FL-501 into the clinic

研究结果证实了GDF-15在恶病质中的作用，并支持将FL-501推进到临床阶段。

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

,

，

April 25, 2025

2025年4月25日

/PRNewswire/ --

/PRNewswire/ --

Leap Therapeutics, Inc.

Leap Therapeutics, Inc.

(Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced it will present preclinical data of FL-501 in a poster presentation at the

(Nasdaq:LPTX)，一家专注于开发靶向和免疫肿瘤治疗药物的生物技术公司，今天宣布将在海报展示中呈现FL-501的临床前数据。

American Association for Cancer Research

美国癌症研究协会

(AACR) Annual Meeting taking place

(AACR) 年会正在举行

April 25-30

4月25日至30日

in

在

Chicago, Illinois

伊利诺伊州芝加哥市

.

。

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.

FL-501 是一种潜在的同类最佳单克隆抗体，靶向生长分化因子 15 (GDF-15)，这是一种与多种疾病和治疗领域相关的细胞因子，包括癌症恶病质。

'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 .

“癌症恶病质是一种毁灭性的、可能危及生命的状况，其特征是显著的体重减轻、肌肉萎缩、疲劳以及生活质量严重下降。它是癌症相关死亡的主要原因之一，不幸的是，目前尚无有效的治疗方案可供患者使用，”

Jason Baum

杰森·鲍姆

, 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.'.

博士，Leap公司的首席科学官。“这些数据不仅表明FL-501是一种新型且潜在的最佳抗GDF-15抗体，而且在临床前模型中能够完全恢复体组成，效果与其它处于临床阶段的抗体相当或更优。我们期待推进FL-501的开发，并计划于2026年将其引入临床。”

Key Findings:

主要发现：

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

在人源化FcRn小鼠研究中，FL-501表现出比其野生型前体和ponsegromab长2-3倍的半衰期，并且清除率降低了50%。

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

在使用GDF-15过表达结直肠癌细胞的小鼠恶病质模型中，FL-501完全恢复了身体组成，效果与临床阶段抗体visugromab和ponsegromab相当或更好。

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

在非小细胞肺癌患者来源的异种移植模型中，FL-501 有效抵消了顺铂引起的体重减轻，恢复了体重、身体组成和状态评分。

These findings confirm GDF-15's role in cachexia and support FL-501's advancement in development

这些发现证实了 GDF-15 在恶病质中的作用，并支持 FL-501 的进一步开发进展。

Poster Details:

海报详情：

Title:

标题：

FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical models

FL-501 是一种潜在的最佳 GDF-15 抑制剂，在临床前模型中表现出延长的半衰期和强效的抗恶病质活性。

Presenter:

主持人：

Roma Kaul, PhD,

罗马·考尔，博士，

Leap Therapeutics

跃升治疗公司

Session Category:

会话类别：

Experimental and Molecular Therapeutics

实验与分子治疗学

Session Title:

会议标题：

New and Emerging Cancer Drug Targets

新型和新兴的癌症药物靶点

Date and Time:

日期和时间：

Tuesday, April 29, 2025

2025年4月29日，星期二

,

，

9:00 a.m.

上午9:00

–

–

12:00 p.m. CT

中午12点（中部时间）

Poster Board Number:

海报板编号：

15

15

Published Abstract Number:

发表的摘要编号：

4258

4258

About FL-501

关于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.

FL-501 是一种处于临床前开发阶段的潜在同类最优单克隆抗体，靶向生长分化因子 15 (GDF-15)，这是一种在多种压力（包括慢性炎症、肥胖、心血管疾病、癌症以及化疗）下会升高产生的细胞因子。

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.

高GDF-15表达与癌症恶病质相关，包括食欲减退、恶心和体重减轻。FL-501被设计为比竞争疗法具有更高的GDF-15亲和力和更长的血浆半衰期。除了恶病质外，FL-501可能能够逆转那些GDF-15升高与生存率低相关的癌症中的免疫抑制，并在治疗其他与GDF-15相关的疾病中发挥作用。

FL-501 is being developed through a collaboration agreement with .

FL-501 正在通过与 的合作协议进行开发。

Adimab

阿迪马布

.

。

About Leap

关于Leap

Leap Therapeutics

跃升治疗公司

(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 (

（纳斯达克：LPTX）专注于开发靶向和免疫肿瘤治疗药物。Leap最先进的临床候选药物sirexatamab（DKN-01）是一种人源化单克隆抗体，靶向Dickkopf-1（

DKK1

DKK1

) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about

）蛋白。Sirexatamab 正在结直肠癌患者中进行研究。Leap 的产品管线还包括 FL-501，一种人源化单克隆抗体，靶向生长分化因子 15（GDF-15）蛋白，目前处于临床前开发阶段。欲了解更多信息，请访问

Leap Therapeutics

Leap Therapeutics

, visit

，访问

http://www.leaptx.com

http://www.leaptx.com

or view our public filings with the

或查看我们公开的文件 filings with the

SEC

证券交易委员会

that are available via EDGAR at

通过EDGAR提供的

http://www.sec.gov

http://www.sec.gov

or via

或通过

https://investors.leaptx.com/

https://investors.leaptx.com/

.

。

FORWARD-LOOKING STATEMENTS

前瞻性声明

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.

本新闻稿包含联邦证券法意义上的前瞻性陈述。此类陈述基于 Leap 管理层的当前计划、估计和预期，这些计划、估计和预期受到各种风险和不确定性的影响，可能导致实际结果与这些陈述存在重大差异。

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..

包含前瞻性陈述不应被视为代表这些计划、估计和预期将会实现。诸如“预期”、“预计”、“展望”、“打算”、“相信”、“可能”、“将”、“应该”、“计划”、“可以”、“继续”、“目标”、“考虑”、“估计”、“预测”、“指引”、“预示”、“可能”、“潜在”、“追求”、“很可能”等词语以及类似含义的词语和术语在涉及未来计划、行动或事件的讨论中使用时，均属于前瞻性陈述。

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.

所有声明，除历史事实外，包括关于 Leap 产品候选物的潜在安全性、有效性以及监管和临床进展的声明；临床试验启动或完成的预期时间、临床试验数据的发布及对其结果的预期；Leap 针对其任何产品候选物的未来临床或临床前产品开发计划；Leap 对预计现金跑道的估算；以及上述任何内容所基于的任何假设，均为前瞻性声明。

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 .

可能导致实际结果与Leap的计划、估计或预期存在重大差异的重要因素包括但不限于：(i) Leap的临床试验和临床前研究的结果，包括DeFianCe研究B部分的最终数据以及FL-501的更多临床前数据，(ii) Leap为sirexatamab或FL-501成功融资或达成新战略合作伙伴关系的能力；(iii) Leap可能收到的任何监管反馈。

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) or equivalent foreign regulatory agency with respect to the sirexatamab or FL-501; (v) whether any Leap products will receive approval from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities.

（FDA）或相当于外国监管机构的关于sirexatamab或FL-501；（v）任何Leap产品是否将获得FDA或相当于外国监管机构的批准；以及（vi）通货膨胀和利率波动的风险，以及Leap交易证券的市场价格波动。

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.

新的风险和不确定性可能会不时出现，无法预测所有风险和不确定性。对于任何此类前瞻性陈述的准确性，不作任何明示或暗示的声明或保证。Leap可能无法实际达成此类前瞻性陈述中披露的预测，您不应过分依赖这些前瞻性陈述。

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 .

此类前瞻性陈述受多种重大风险和不确定性的影响，包括但不限于Leap最近一份年度报告Form 10-K中“风险因素”标题下所列出的内容。

SEC

证券交易委员会

, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the

以及对其后续文件中潜在风险、不确定性及其他重要因素的讨论，

SEC

证券交易委员会

. 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.

任何前瞻性声明仅在其作出之日有效。Leap及其任何关联公司、顾问或代表均不承担公开更新或修改任何前瞻性声明的义务，无论是否由于新信息、未来事件或其他原因，除非法律要求。

These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof..

这些前瞻性陈述不应被视为代表Leap在本日期之后的任何日期的观点。

CONTACT:

联系人：

Douglas E. Onsi

道格拉斯·E·昂西

President & Chief Executive Officer

总裁兼首席执行官

Leap Therapeutics, Inc.

Leap Therapeutics, Inc.

617-714-0360

617-714-0360

donsi@leaptx.com

donsi@leaptx.com

Matthew DeYoung

马修·德扬

Investor Relations

投资者关系

Argot Partners

行话伙伴

212-600-1902

212-600-1902

leap@argotpartners.com

leap@argotpartners.com

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Leap Therapeutics, Inc.

Leap Therapeutics, Inc.