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- 28% confirmed response rate (5/18) per RECIST v1.1 in unselected patients

- 根据RECIST v1.1标准，未选择患者中的确认应答率为28%（5/18）

across doses prioritized for expansion (

跨剂量优先扩展（

7.2, 8.6 and 10 mg/kg Q3W)

7.2、8.6 和 10 mg/kg Q3W

-

-

- 3 of 7 evaluable patients (43%) with confirmed responses at upper expansion dose (10 mg/kg Q3W) -

- 在高剂量扩展组（10 mg/kg Q3W）中，7名可评估患者中有3名（43%）确认出现缓解 -

- M

- M

edian progression free survival of 5.8 months as of

中位无进展生存期为5.8个月截至

April 7

4月7日

th

th

2025 data cutoff -

2025年数据截止 -

- Encouraging initial safety profile with no dose limiting toxicities at data cutoff -

- 鼓励性的初步安全概况，在数据截止时没有剂量限制性毒性 -

- Planning Phase 2 study initiation in 1H 2026 -

- 计划在2026年上半年启动第二阶段研究 -

- Conference call on

- 电话会议开启

Monday, May 12

5月12日，星期一

at

在

8:00 a.m. ET

早上8点（东部时间）

-

-

SOUTH SAN FRANCISCO, Calif.

加利福尼亚州南旧金山

,

，

May 12, 2025

2025年5月12日

(GLOBE NEWSWIRE) --

（环球新闻社）--

CytomX Therapeutics, Inc.

CytomX Therapeutics公司

(Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced positive interim Phase 1 data for its EpCAM PROBODY

(Nasdaq: CTMX)，作为隐蔽、条件激活生物制剂领域的领导者，今天宣布了其EpCAM PROBODY的1期临床试验积极的中期数据。

®

®

ADC candidate, CX-2051, in advanced, late-line CRC. The data are as of an

ADC候选药物CX-2051在晚期、后线CRC中的数据截至

April 7

4月7日

th

th

2025 data cutoff from the ongoing CTMX-2051-101 Phase 1 study.

2025年数据截止于正在进行的CTMX-2051-101一期研究。

“EpCAM is a high potential and broadly expressed cancer target that has been challenging to drug historically due to expression on normal tissues. We believe we have broken important new ground with our data announced today, which show potential for markedly improved outcomes for CRC patients,” said .

“EpCAM 是一种具有高潜力且广泛表达的癌症靶点，由于在正常组织中的表达，历来难以成药。我们认为，我们今天公布的数据已经开辟了重要的新天地，这些数据表明有可能显著改善结直肠癌患者的治疗效果，”研究人员表示。

Sean McCarthy

肖恩·麦卡锡

,

，

D. Phil

哲学博士

, chief executive officer and chairman of CytomX. “CX-2051 is showing impressive, durable anti-tumor activity in late line metastatic CRC, an area of high unmet need and a very difficult tumor to treat. Furthermore, CX-2051 has been generally well tolerated, highlighting the power of CytomX PROBODY

CytomX的首席执行官兼董事长表示：“CX-2051在晚期转移性结直肠癌中显示出令人印象深刻的持久抗肿瘤活性，这一领域存在高度未满足的需求，并且肿瘤非常难以治疗。此外，CX-2051通常具有良好的耐受性，突显了CytomX的PROBODY技术的强大优势。”

®

®

masking technology.”

“掩蔽技术。”

Dr. McCarthy

麦卡锡博士

added, “Importantly, we believe these results validate EpCAM as an oncology target and unlock a broad development opportunity for CX-2051 in CRC and potentially many other cancer types where EpCAM is expressed. We are excited to rapidly advance CX-2051 for the benefit of CRC patients and to explore the full potential of this novel ADC.”.

补充道：“重要的是，我们认为这些结果验证了EpCAM作为肿瘤学靶点的价值，并为CX-2051在结直肠癌及其他可能表达EpCAM的众多癌症类型中开启了广泛的开发机会。我们非常期待快速推进CX-2051，以造福结直肠癌患者，并探索这款新型ADC的全部潜力。”

CX-2051 Phase 1a Interim Data Summary in Advanced, Late-line Colorectal Cancer

CX-2051第一阶段1a期中期数据总结：晚期、后线结直肠癌

The CTMX-2051-101 study was initiated in

CTMX-2051-101 研究已启动。

April 2024

2024年4月

with dose escalation proceeding through seven dose levels as of

随着剂量递增通过七个剂量水平进行

April 2025

2025年4月

.

。

25 advanced metastatic CRC patients were treated with CX-2051 across dose levels 1 through 5 as of the

截至当时，25名晚期转移性结直肠癌患者在1至5剂量水平范围内接受了CX-2051的治疗。

April 7, 2025

2025年4月7日

data cutoff. CX-2051 was administered on a once every three week schedule (Q3W).

数据截止。CX-2051 每三周一次 (Q3W) 给药。

The 2.4 mg/kg and 4.8 mg/kg doses were single patient dose escalation cohorts not anticipated to be therapeutically active.

2.4 mg/kg 和 4.8 mg/kg 剂量为单患者剂量递增队列，预计不会产生治疗活性。

At the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, 23 patients were treated in total, 18 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff.

在 7.2 毫克/千克、8.6 毫克/千克和 10 毫克/千克剂量下，共有 23 名患者接受了治疗，其中 18 名患者可进行疗效评估，这些患者在数据截止时至少进行了一次基线后肿瘤评估。

Patient Characteristics:

患者特征：

The 25 patients enrolled in the study across dose levels 1 through 5 had previously received a median of 4 prior lines of therapy and all patients had previously been treated with irinotecan. 64% of patients had liver metastases, 64% had KRAS mutations, and 96% were microsatellite stable.

研究中纳入的25名患者，涉及剂量水平1至5，既往接受过的治疗中位线数为4线，且所有患者都曾接受过伊立替康治疗。64%的患者有肝转移，64%存在KRAS突变，96%为微卫星稳定型。

Patients were not preselected based on EpCAM expression levels.

患者并非基于EpCAM表达水平进行预先筛选。

Efficacy Results:

疗效结果：

As of the data cutoff, 18 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W.

截至数据截止时，18名患者在7.2 mg/kg、8.6 mg/kg和10 mg/kg Q3W的扩展剂量下可进行疗效评估。

Overall response rate (ORR):

总体缓解率（ORR）：

28% of patients (5/18) achieved confirmed partial RECIST v. 1.1 responses. Overall response rates for currently approved therapies in 3

28%的患者（5/18）获得了经确认的部分RECIST v. 1.1反应。目前批准的疗法在3个方面的总体反应率。

rd

研发

line or later CRC are in the low to mid-single digit percentages

后续线路或后期CRC处于较低的个位数百分比范围

1

1

.

。

At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses.

在10毫克/千克的剂量下，7名可评估患者中有3名（43%）获得了确认的部分缓解。

The Disease Control Rate

疾病控制率

2

2

was 94% across the three dose groups (17/18).

在三个剂量组中为94%（17/18）。

Durability:

耐久性：

Median progression free survival was 5.8 months as of the data cutoff.

截至数据截止时，中位无进展生存期为5.8个月。

10 of 18 patients remained on study treatment as of the data of cutoff.

截至数据截止日期，18名患者中有10名仍在接受研究治疗。

Safety Results:

安全性结果：

As of the data cutoff, 25 patients were evaluable for safety.

截至数据截止时，25名患者可进行安全性评估。

CX-2051 was generally well-tolerated with manageable adverse events, with no observed dose limiting toxicities. Most treatment related adverse events (TRAEs) were Grade 1 or Grade 2 in severity.

CX-2051总体耐受性良好，不良事件可控，未观察到剂量限制性毒性。大多数治疗相关不良事件（TRAEs）的严重程度为1级或2级。

The most common reported TRAEs were diarrhea (18 patients, 5 Grade 3), nausea (11 patients, 1 Grade 3), vomiting (8 patients, No Grade 3), fatigue (8 patients, 1 Grade 3), anemia (5 patients, 3 Grade 3), hypokalemia (3 patients, 1 Grade 3), neutrophil count decrease (2 patients, 2 Grade 3) and neutropenia (2 patients, 1 Grade 3).

最常见的报告的TRAE包括腹泻（18名患者，5名为3级），恶心（11名患者，1名为3级），呕吐（8名患者，无3级），疲劳（8名患者，1名为3级），贫血（5名患者，3名为3级），低钾血症（3名患者，1名为3级），中性粒细胞计数减少（2名患者，2名为3级）和中性粒细胞减少（2名患者，1名为3级）。

TRAEs included serious adverse events in 5 patients (1 Grade 2, 4 Grade 3). No Grade 4 or 5 TRAEs were observed..

治疗相关的严重不良事件发生在5名患者中（1例为2级，4例为3级）。未观察到4级或5级的治疗相关不良事件。

No events of pancreatitis, interstitial lung disease or febrile neutropenia were reported at time of data cutoff.

在数据截止时，未报告胰腺炎、间质性肺病或发热性中性粒细胞减少的事件。

CX-2051 Phase 1 Dose Expansions Initiated:

CX-2051 第一阶段剂量扩展已启动：

Dose expansions have been initiated at doses of 7.2 mg/kg, 8.6 mg/kg and 10 mg/kg Q3W.

剂量扩展已在每三周7.2 mg/kg、8.6 mg/kg和10 mg/kg的剂量下启动。

A total of 20 patients are expected to be enrolled at each dose level to inform the selection of recommended phase 2 dose.

预计每个剂量水平将招募20名患者，以帮助确定推荐的二期剂量。

CX-2051 Anticipated Milestones:

CX-2051 预期里程碑：

CX-2051 Monotherapy for Advanced Late-Line CRC:

CX-2051单药治疗晚期结直肠癌：

Additional Phase 1 data update by Q1 2026

2026年第一季度前更新第一阶段的额外数据

Planning Phase 2 study initiation in 1H 2026

计划在2026年上半年启动第二阶段研究

CX-2051 CRC Combinations:

CX-2051 CRC组合：

Potential to initiate CX-2051 combination studies in earlier lines of CRC in 2026

2026年有可能在更早的CRC治疗线中启动CX-2051组合研究

CX-2051 Pan-tumor Potential:

CX-2051 泛肿瘤潜力：

Evaluate non-CRC, EpCAM-expressing tumor indications for potential Phase 1b study initiation in 2026

评估非CRC、表达EpCAM的肿瘤适应症，以期在2026年启动潜在的1b期研究。

CytomX Investor Event Information

CytomX投资者活动信息

Additional details will be provided on the Company’s Investor Call on

公司将在投资者电话会议上提供更多信息。

May 12, 2025

2025年5月12日

at

在

8 a.m. EST

东部时间上午8点

. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at

参与者可以通过CytomX官网的“活动与演示”页面访问电话会议的实时网络直播。

https://ir.cytomx.com/events-and-presentations

https://ir.cytomx.com/events-and-presentations

. Participants may register for the conference call

参与者可以注册参加电话会议

here

这里

and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website for at least 30 days.

并且建议他们在加入通话前至少10分钟这样做。网络直播的存档回放将在公司网站上提供至少30天。

About

关于

CTMX-2051-101

CTMX-2051-101

Study

学习

Additional information about the CTMX-2051-101 study can be found

有关CTMX-2051-101研究的更多信息，请参见

here

这里

on

打开

clinicaltrials.gov

临床试验.gov

.

。

About CX-2051 (EpCAM PROBODY

关于CX-2051（EpCAM PROBODY）

®

®

ADC)

模数转换器）

CX-2051 is an investigational masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM) and armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC, and was discovered in collaboration with ImmunoGen, now part of AbbVie.

CX-2051 是一种研究性掩蔽、条件激活的抗体药物偶联物 (ADC)，靶向表皮细胞粘附分子 (EpCAM)，并搭载拓扑异构酶-1 抑制剂载荷。CX-2051 在多种表达 EpCAM 的上皮癌症（包括结直肠癌）中具有潜在应用价值，并由 ImmunoGen（现为 AbbVie 一部分）合作发现。

EpCAM (Epithelial Cell Adhesion Molecule) is a highly expressed but previously undruggable tumor antigen due to expression on normal tissues. CX-2051 is designed to open a therapeutic window for this high potential target and to deliver meaningful anti-cancer activity in solid tumors, including CRC..

EpCAM（上皮细胞粘附分子）是一种在正常组织上表达的、此前无法成药的肿瘤抗原。CX-2051旨在为这一高潜力靶点打开治疗窗口，并在包括结直肠癌在内的实体瘤中提供显著的抗癌活性。

About CytomX Therapeutics

关于CytomX治疗学

CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY

CytomX是一家处于临床阶段、专注于肿瘤学的生物制药公司，致力于开发新型条件性激活的隐蔽生物制剂，这些制剂旨在定位于肿瘤微环境。通过其PROBODY技术驱动，开创了一条新型局部生物制剂的研发管线。

®

®

therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (ADCs), T-cell engagers, and immune modulators such as cytokines.

治疗平台，CytomX的愿景是为癌症治疗创造更安全、更有效的疗法。CytomX强大而多样化的管线包括多种治疗方式的候选药物，包括抗体药物偶联物（ADC）、T细胞接合器和免疫调节剂如细胞因子。

CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. CX-2051 is a masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM), armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC.

CytomX的临床阶段管线包括CX-2051和CX-801。CX-2051是一种针对上皮细胞粘附分子（EpCAM）的掩蔽型条件激活ADC，搭载了拓扑异构酶-1抑制剂载荷。CX-2051在多种表达EpCAM的上皮癌症中具有潜在应用价值，包括结直肠癌（CRC）。

CX-801 is a masked interferon alpha-2b PROBODY.

CX-801是一种经过修饰的干扰素α-2b前体抗体。

®

®

cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas,

具有广泛潜在适用性的细胞因子，可用于传统免疫肿瘤学敏感以及不敏感（冷）肿瘤。CytomX已与多家肿瘤学领域的领导者建立了战略合作关系，包括安进、安斯泰来，

Bristol Myers Squibb

百时美施贵宝

, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit

，再生元和莫德纳。如需了解更多关于CytomX的信息以及该公司如何努力使条件激活治疗成为抗癌新标准，请访问

www.cytomx.com

www.cytomx.com

and follow us on

并关注我们

LinkedIn

领英

and

和

X

X

(formerly Twitter)

（前称Twitter）

.

。

CytomX Therapeutics Forward-Looking Statements

CytomX Therapeutics 前瞻性声明

This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to CX-2051.

本新闻稿包含前瞻性声明。此类前瞻性声明涉及已知和未知的风险、不确定性以及其他难以预测的重要因素，这些因素可能超出我们的控制范围，并可能导致实际结果、业绩或成就与此类声明中明示或暗示的任何未来结果、业绩或成就存在重大差异，包括与CX-2051相关的内容。

Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2051 and CX-801, the potential benefits or applications of CytomX’s PROBODY.

因此，你不应依赖于任何这些前瞻性声明，包括与CytomX或其任何合作合作伙伴的产品候选物（包括CX-2051和CX-801）的潜在益处、安全性、有效性或进展相关的声明，以及与CytomX的PROBODY相关的潜在益处或应用相关的声明。

®

®

therapeutic platform, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2051 and CX-801 and the timing of initial and ongoing data availability for our clinical trials, including CX-2051 and CX-801, and other development milestones.

治疗平台，CytomX或其合作合作伙伴开发并将候选产品推进到临床试验并成功完成临床试验的能力，包括正在进行和计划中的CX-2051和CX-801临床试验，以及我们的临床试验（包括CX-2051和CX-801）的初步和持续数据可用性时间，以及其他开发里程碑。

Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY.

可能导致前瞻性陈述具有不确定性的风险和不确定性包括：CytomX新型PROBODY的未经验证的性质。

®

®

therapeutic technology; uncertainties around the Company’s ability to raise sufficient funds to carry out its planned research and development; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-2051 results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2051 and CX-801; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in .

治疗技术；公司能否筹集足够资金以开展其计划中的研发工作的不确定性；CytomX的临床试验产品候选物处于临床开发的初始阶段，其其他产品候选物目前处于临床前开发阶段，而临床前和临床开发过程可能导致获批产品的路径漫长且充满重大风险和不确定性，包括临床前研究和早期临床试验（包括初步的CX-2051结果）可能无法预测未来结果的可能性；CytomX的临床试验可能不会成功的可能性；当前临床前研究可能无法产生更多产品候选物的可能性；CytomX对CX-2051和CX-801的成功依赖；CytomX依靠第三方制造公司的产品候选物；可能的监管进展。

the United States

美国

and foreign countries, including

以及包括

China

中国

and the

和

European Union

欧盟

; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses or may not obtain expected savings from our announced restructuring. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading 'Risk Factors' included in CytomX’s Quarterly Report on Form 10-Q filed with the .

；我们可能面临研发成本高于预期或出现意外成本和费用的风险，也可能无法从我们宣布的重组中获得预期的节省。其他适用的风险和不确定性包括与我们临床前研究和开发、临床开发相关的风险，以及在CytomX提交的10-Q季度报告中“风险因素”标题下确定的其他风险。

SEC

证券交易委员会

on

开

May 12, 2025

2025年5月12日

. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise..

本新闻稿中包含的前瞻性陈述基于CytomX当前可获得的信息，仅在其作出的日期有效。CytomX不承担且明确拒绝任何更新前瞻性陈述的义务，无论是否因新信息、未来事件、情况变化或其他原因。

PROBODY is a

PROBODY 是一个

U.S.

美国

registered trademark of

注册商标

CytomX Therapeutics, Inc.

CytomX治疗公司

All other trademarks are the properties of their respective owners.

所有其他商标均为其各自所有者的财产。

Company Contact:

公司联系人：

Chris Ogden

克里斯·奥格登

SVP, Chief Financial Officer

高级副总裁，首席财务官

cogden@cytomx.com

cogden@cytomx.com

Investor Contact:

投资者联系方式：

Precision AQ (formerly Stern Investor Relations)

精准AQ（原名Stern投资者关系）

Stephanie Ascher

斯蒂芬妮·阿舍

Stephanie.Ascher@precisionaq.com

Stephanie.Ascher@precisionaq.com

Media Contact:

媒体联系人:

Redhouse Communications

红房子通讯

Teri Dahlman

特里·达尔曼

teri@redhousecomms.com

特里@红房子通讯.com

1

1

Lonsurf

朗斯氟（Lonsurf）

®

®

, Fruzaqla

，弗鲁扎克拉

®

®

, Stivarga

，Stivarga

®

®

package inserts

包装插页

2

2

Disease Control Rate: Patients achieving a best response of stable disease, partial response, or complete response.

疾病控制率：达到最佳反应为疾病稳定、部分缓解或完全缓解的患者。

Source: CytomX Therapeutics Inc.

来源：CytomX Therapeutics Inc.