Updated data from DeFianCe study continue to demonstrate statistically significant improvements in PFS among the

DeFianCe研究的最新数据继续显示PFS方面具有统计学意义的显著改善。

DKK1

DKK1

-high, VEGF-naïve and liver metastasis subgroups

-高、VEGF初治和肝转移亚组

Board of Directors has initiated process to explore strategic alternatives

董事会已启动探索战略替代方案的进程。

to maximize shareholder value

最大化股东价值

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

,

，

June 23, 2025

2025年6月23日

/PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported updated results from Part B of the DeFianCe study (

/PRNewswire/ -- Leap Therapeutics, Inc.（纳斯达克股票代码：LPTX），一家专注于开发靶向和免疫肿瘤治疗的生物技术公司，今天报告了DeFianCe研究B部分的最新结果。

NCT05480306

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.

), 一项关于西雷萨单抗（DKN-01）的二期研究，这是一种抗DKK1单克隆抗体，与贝伐珠单抗和化疗联合使用（西雷萨单抗组）对比贝伐珠单抗和化疗（对照组），用于治疗已接受过一种先前系统治疗的晚期微卫星稳定（MSS）结直肠癌（CRC）患者。

Due to the Company's financial position, Leap's Board of Directors is taking further steps to preserve capital and has initiated a process to explore strategic options to preserve and maximize shareholder value..

由于公司的财务状况，Leap 的董事会正在采取进一步措施来保存资本，并已启动了一项程序以探索战略选项来保存并最大化股东价值。

'Sirexatamab demonstrated a statistically significant benefit in patients with high levels of

‘Sirexatamab 在高水平的患者中显示出统计学上的显著益处

DKK1

DKK1

, no prior exposure to anti-VEGF therapy, or liver metastasis, with a positive trend on ORR and PFS in the full second-line CRC population. With the additional patient follow-up, we believe that the objectives of the DeFianCe study have been achieved. On behalf of everyone at Leap, I thank all the patients and physicians who have participated in our sirexatamab clinical trials,' said .

，未接受过抗VEGF治疗或肝转移的患者，在整个二线结直肠癌人群中，ORR和PFS呈现积极趋势。随着更多的患者随访数据，我们相信DeFianCe研究的目标已经达成。代表Leap的所有人，我感谢所有参与我们sirexatamab临床试验的患者和医生。

Douglas E. Onsi

道格拉斯·E·昂西

, President and Chief Executive Officer of Leap. 'However, due to current market conditions, we have decided to wind-down the DeFianCe clinical trial and further reduce internal expenses. In parallel, we have initiated a review of the full range of strategic alternatives to maximize shareholder value.'.

，Leap的总裁兼首席执行官。“然而，由于当前的市场状况，我们决定停止DeFianCe临床试验，并进一步减少内部开支。同时，我们已开始审查一系列战略选择，以最大化股东价值。”

DeFianCe Study Update

反抗研究更新

In the updated analysis as of

在更新的分析中，截至

May 22, 2025

2025年5月22日

, sirexatamab demonstrated a positive trend on overall response rate (ORR), by investigator assessment (IA) and blinded independent central review (BICR), and progression-free survival (PFS) in the full second-line CRC population, driven by the statistically significant benefit in patients with high levels of .

，Sirexatamab在总体反应率（ORR）、研究者评估（IA）和盲态独立中心审查（BICR）以及全二线CRC人群的无进展生存期（PFS）方面显示出积极趋势，这主要得益于高水平患者的统计学显著获益。

DKK1

DKK1

, no prior exposure to anti-VEGF therapy, or liver metastasis.

，没有事先接受过抗VEGF治疗，或肝转移。

Across the intent-to-treat population (n=188):

在意向治疗人群（n=188）中：

Sirexatamab Arm

西雷昔单抗组

(n=94)

(n=94)

Control Arm

控制臂

(n=94)

(n=94)

Median PFS

中位无进展生存期

9.2 months

9.2个月

8.31 months

8.31个月

HR 0.84

人力资源 0.84

95% CI: 0.57, 1.22

95% 置信区间：0.57, 1.22

p = 0.1749

p = 0.1749

ORR by IA

由IA评估的ORR

35.1 %

35.1 %

26.6 %

26.6 %

p = 0.1009

p = 0.1009

ORR by BICR

通过BICR的ORR

33.0 %

33.0 %

20.2 %

20.2 %

P = 0.0203

P = 0.0203

Remaining on study drug

留在研究药物中

21

21

15

15

In patients with high

在高危患者中

DKK1

DKK1

levels (upper quartile, n=44):

水平（上四分位数，n=44）：

Sirexatamab Arm

西雷昔单抗组

(n=25)

(n=25)

Control Arm

控制臂

(n=19)

(n=19)

Median PFS

中位无进展生存期

9.36 months

9.36个月

5.88 months

5.88个月

HR 0.47

人力资源 0.47

95% CI: 0.22, 1.01

95% 置信区间：0.22, 1.01

p = 0.0237

p = 0.0237

ORR by IA

IA评估的ORR

44.0 %

44.0 %

15.8 %

15.8 %

p = 0.0149

p = 0.0149

ORR by BICR

BICR评估的ORR

40.0 %

40.0 %

15.8 %

15.8 %

p = 0.0301

p = 0.0301

Median OS

中位总生存期

Not Yet Reached

尚未到达

9.66 months

9.66个月

HR 0.19

人力资源 0.19

95% CI: 0.05, 0.73

95% 置信区间：0.05, 0.73

p = 0.0037

p = 0.0037

Remaining on study drug

留在研究药物中

7

7

1

1

In patients with

在患者中

DKK1

DKK1

levels above the median (upper median, n=88):

高于中位数的水平（中位数以上，n=88）：

Sirexatamab Arm

西雷昔单抗组

(n=50)

(n=50)

Control Arm

控制臂

(n=38)

(n=38)

Median PFS

中位无进展生存期

9.03 months

9.03个月

7.23 months

7.23个月

HR 0.56

人力资源 0.56

95% CI: 0.33, 0.94

95% 置信区间：0.33, 0.94

p = 0.0146

p = 0.0146

ORR by IA

IA评估的ORR

38.0 %

38.0 %

23.7 %

23.7 %

p = 0.0706

p = 0.0706

ORR by BICR

通过BICR的ORR

40.0 %

40.0 %

15.8 %

15.8 %

p = 0.0039

p = 0.0039

Median OS

中位总生存期

Not Yet Reached

尚未达到

14.39 months

14.39个月

HR 0.48

人力资源 0.48

95% CI: 0.2, 1.16

95% 置信区间：0.2, 1.16

p = 0.0475

p = 0.0475

Remaining on study drug

继续使用研究药物

12

十二

3

3

In patients who had not received prior anti-VEGF therapy (n=95):

在未接受过抗VEGF治疗的患者中（n=95）：

Sirexatamab Arm

西雷昔单抗组

(n=49)

(n=49)

Control Arm

控制臂

(n=46)

(n=46)

Median PFS

中位无进展生存期

11.2 months

11.2个月

8.34 months

8.34个月

HR 0.61

人力资源 0.61

95% CI: 0.35, 1.06

95%置信区间：0.35，1.06

p = 0.0383

p = 0.0383

ORR by IA

IA评估的ORR

55.1 %

55.1 %

32.6 %

32.6 %

p = 0.0116

p = 0.0116

ORR by BICR

通过BICR的ORR

44.9 %

44.9 %

26.1 %

26.1 %

p = 0.0252

p = 0.0252

Median OS

中位总生存期

Not Yet Reached

尚未达到

Not Yet Reached

尚未到达

HR 0.47

人力资源 0.47

95% CI: 0.14, 1.6

95% 置信区间：0.14, 1.6

p = 0.1069

p = 0.1069

Remaining on study drug

留在研究药物中

15

15

5

5

In patients with liver metastases (n=138):

在肝转移患者中（n=138）：

Sirexatamab Arm

西雷昔单抗组

(n=73)

(n=73)

Control Arm

控制臂

(n=65)

(n=65)

Median PFS

中位无进展生存期

9.03 months

9.03个月

7.26 months

7.26个月

HR 0.7

人力资源 0.7

95% CI: 0.46, 1.06

95% 置信区间：0.46，1.06

p = 0.0443

p = 0.0443

ORR by IA

IA评估的ORR

37.0 %

37.0 %

27.7 %

27.7 %

p = 0.1203

p = 0.1203

ORR by BICR

BICR评估的ORR

30.1 %

30.1 %

24.6 %

24.6 %

p = 0.233

p = 0.233

Median OS

中位总生存期

Not Yet Reached

尚未达到

15.74

15.74

HR 0.69

人力资源 0.69

95% CI: 0.33, 1.43

95% 置信区间：0.33, 1.43

p = 0.1584

p = 0.1584

Remaining on study drug

继续使用研究药物

14

14

6

6

Corporate Update

公司更新

Leap is taking additional steps to reduce spending and preserve capital. Over the next two months as the DeFianCe study completes, the Company will implement a workforce reduction of approximately 75%. The total cash payments and costs related to this reduction in force, including severance payments, are estimated to be approximately .

Leap正在采取额外的措施来减少开支并保存资本。在接下来的两个月内，随着DeFianCe研究的完成，公司将裁员约75%。与此裁员相关的总现金支付和成本，包括遣散费，预计约为 。

$3.2 million

320万美元

. The majority of these costs will be recognized in the third quarter of 2025. The Company's cash and cash equivalents totaled

其中大部分成本将在2025年第三季度确认。公司的现金及现金等价物总计

$32.7 million

3270万美元

as of

截至

March 31, 2025

2025年3月31日

.

。

Leap has initiated a process to explore strategic alternatives to preserve and maximize shareholder value, including leveraging its cash balance and exploring potential sale or partnership opportunities for sirexatamab and FL-501. The Company's Board of Directors has approved the engagement of

Leap 已启动一项探索战略替代方案的进程，以保护并最大化股东价值，包括利用其现金余额以及探索 sirexatamab 和 FL-501 的潜在出售或合作机会。公司董事会已批准聘请

Raymond James & Associates, Inc.

雷蒙德詹姆斯公司

to serve as exclusive financial advisor to assist in the strategic evaluation process.

作为独家财务顾问，协助进行战略评估过程。

About Leap Therapeutic

关于Leap Therapeutic

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 (

Leap Therapeutics（纳斯达克股票代码：LPTX）专注于开发靶向治疗和免疫肿瘤学疗法。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 and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit

）蛋白。Sirexatamab 正在结直肠癌患者中进行研究。Leap 的产品线还包括 FL-501，这是一种处于临床前开发阶段的、靶向生长和分化因子 15 (GDF-15) 蛋白的人源化单克隆抗体。欲了解有关 Leap Therapeutics 的更多信息，请访问

http://www.leaptx.com

http://www.leaptx.com

or view our public filings with the SEC that are available via EDGAR at

或通过EDGAR查看我们向SEC提交的公开文件， доступный на

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声明。此类声明基于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声明存在重大差异。

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将实现此类计划、估计和预期。诸如“预期”、“预计”、“展望”、“打算”、“相信”、“可能”、“将”、“应该”、“计划”、“能够”、“继续”、“目标”、“考虑”、“估计”、“预测”、“指导”、“预示”、“可能”、“潜在”、“追求”、“有可能”，以及与任何未来计划、行动或事件讨论相关的类似含义的词语和术语，均用于识别前瞻性陈述。

All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates, including sirexatamab and FL-501; Leap's intention to implement a workforce reduction of approximately 75%, 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.

所有声明，除历史事实外，包括关于Leap产品候选物（包括sirexatamab和FL-501）的潜在安全性、有效性以及监管和临床进展的声明；Leap计划实施约75%的员工缩减、减少临床和运营活动、削减开支并保留现金，探索保持和最大化股东价值的战略选择，包括利用其现金余额并可能出售或合作sirexatamab或FL-501；以及任何上述声明所依据的假设，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) 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 clinical 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; (iv) the magnitude, timing and costs associated with the implementation of a workforce reduction; and (v) the availability of strategic alternatives would preserve or generate any shareholder value.

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成功销售sirexatamab或FL-501或达成相关合作的能力；(ii) 完成DeFianCe研究及终止临床运营的成本和时间表；(iii) Leap可能从美国食品药品监督管理局 (FDA) 或同等外国监管机构，或现场机构审查委员会收到的任何监管反馈；(iv) 实施裁员相关的规模、时间和成本；以及 (v) 是否存在能够保留或创造股东价值的战略替代方案。

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可能无法实际实现此类前瞻性陈述中披露的预测，您不应过度依赖这些前瞻性陈述。

Such forward-looking statements are subject t.

此类前瞻性陈述受制于。

CONTACT:

联系：

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

黑话伙伴

212-600-1902

212-600-1902

leap@argotpartners.com

leap@argotpartners.com

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Leap Therapeutics, Inc.

Leap Therapeutics, Inc.