-- XENITH-UC, a Phase 2b study of XmAb942 in participants with ulcerative colitis, to begin in the second half of 2025 --

-- XENITH-UC，一项针对溃疡性结肠炎患者的XmAb942二期b阶段研究，将于2025年下半年开始 --

-- Single and multiple doses of XmAb942 are well tolerated and safety profile is consistent with the anti-TL1A drug class --

-- 单剂量和多剂量的XmAb942耐受性良好，其安全性与抗TL1A药物类别一致 --

-- XmAb942 half-life supports a 12-week maintenance dosing interval in XENITH-UC --

-- XmAb942 的半衰期支持在 XENITH-UC 中每 12 周一次的维持剂量间隔 --

-- Lead selection for XmAb TL1A x IL23p19 program on track for first-in-human study start in 2026 --

-- XmAb TL1A x IL23p19项目的关键选择正按计划进行，预计于2026年开始首次人体研究 --

-- Management hosting webcast and conference call at

-- 管理层主办的网络直播和电话会议

5:00 p.m. ET

下午5:00（东部时间）

/

/

2:00 p.m. PT

下午2:00（太平洋时间）

today --

今天——

PASADENA, Calif.

加利福尼亚州帕萨迪纳市

--(BUSINESS WIRE)--Apr. 29, 2025--

--（商业资讯）--2025年4月29日--

Xencor, Inc.

Xencor公司

(NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today announced positive interim results from its first-in-human study of XmAb942, a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD).

(NASDAQ:XNCR)是一家临床阶段的生物制药公司，专注于开发用于治疗癌症和自身免疫性疾病的工程抗体。该公司今天宣布了其首款人体研究的积极中期结果，该研究涉及 XmAb942，一种高效、延长半衰期的研究性抗 TL1A 抗体，目前正在针对炎症性肠病（IBD）患者进行临床开发，例如溃疡性结肠炎（UC）和克罗恩病（CD）。

Interim results from the healthy volunteer dose-escalation study indicate that XmAb942 is well tolerated at single and multiple doses. Pharmacokinetic analysis of the single dose cohorts estimates a human half-life of greater than 71 days for XmAb942, which supports a 12-week dosing interval during maintenance treatment..

健康志愿者剂量递增研究的中期结果表明，XmAb942 在单次和多次剂量下均具有良好的耐受性。对单剂量队列的药代动力学分析估计，XmAb942 的人体半衰期超过 71 天，这支持在维持治疗期间采用 12 周的给药间隔。

Based on these positive interim results,

基于这些积极的中期结果，

Xencor

Xencor

is initiating the XENITH clinical program, advancing XmAb942 into a Phase 2b study in patients with moderate-to-severely active UC (XENITH-UC), with the expected study start in the second half of 2025.

正在启动XENITH临床项目，将XmAb942推进到中至重度活动性UC（XENITH-UC）患者的2b期研究，预计研究将在2025年下半年开始。

Lead selection for Xencor’s XmAb TL1A x IL23p19 bispecific antibody continues to advance. New

Xencor公司的XmAb TL1A x IL23p19双特异性抗体的先导选择继续取得进展。新的

in vitro

体外

studies show that several lead candidates match the target inhibition potency of commercial monospecific antibodies, but in a simple bispecific immunoglobulin G (IgG) format. Currently, these candidates are in final lead selection studies and manufacturing, in parallel, to prepare for the first-in-human study planned for 2026..

研究表明，有几个先导候选药物在简单的双特异性免疫球蛋白G（IgG）格式下，与商业单特异性抗体的目标抑制效力相匹配。目前，这些候选药物正在进行最终的先导选择研究和生产准备，并计划于2026年进行首次人体研究。

'Our Phase 1 data for XmAb942 validate our design goals for a best-in-class anti-TL1A therapy, combining high potency with less frequent dosing to potentially improve clinical outcomes and convenience for patients living with inflammatory bowel disease,' said

“XmAb942的1期数据验证了我们设计目标，即开发一种一流的抗TL1A疗法，将高效力与较少的给药频率相结合，有可能改善炎症性肠病患者的临床结果和便利性，”表示

Bassil Dahiyat

巴西勒·达希亚特

, Ph.D., president and chief executive officer at

，博士，总裁兼首席执行官 tại

Xencor

Xencor

. 'We are excited to start our Phase 2b XENITH-UC trial later this year to efficiently support dose selection for pivotal studies, and we are poised to select our TL1A x IL23p19 bispecific lead candidate for an anticipated Phase 1 start in 2026. These and other milestones across our clinical portfolio are supported by our strong cash position.'.

“我们很高兴在今年晚些时候启动我们的2b期XENITH-UC试验，以有效支持关键研究的剂量选择，并且我们准备在2026年预计开始1期试验时选择我们的TL1A x IL23p19双特异性先导候选药物。我们临床组合中的这些和其他里程碑都得到了我们强劲现金头寸的支持。”

Key Highlights From Phase 1 Study Interim Results

第一阶段研究中期结果的关键亮点

The Phase 1 study of XmAb942 in healthy volunteers is a randomized, double-blind, placebo-controlled, dose-escalation trial, exploring intravenous (IV) and subcutaneous (SC) dose administration, at three escalating dose levels. The interim results reflect analyses with subjects in single dose cohorts (IV, n=24; SC, n=24) and in multiple dose cohorts (IV, n=16)..

XmAb942在健康志愿者中的I期研究是一项随机、双盲、安慰剂对照、剂量递增试验，探索了三个递增剂量水平下的静脉注射（IV）和皮下注射（SC）给药方式。中期结果反映了对单剂量组（IV，n=24；SC，n=24）和多剂量组（IV，n=16）受试者的分析。

Safety: The blinded interim safety analysis indicates that all dose levels and routes of administration of treatment were well tolerated. No serious adverse events were observed, and no adverse events led to discontinuation from the study. The study remains blinded until follow-up is completed for the multiple dose portion of the study..

安全性：盲态中期安全性分析表明，所有剂量水平和给药途径的治疗均具有良好的耐受性。未观察到严重不良事件，且无任何不良事件导致受试者退出研究。在完成多剂量部分研究的随访之前，研究仍将保持盲态。

Pharmacokinetics: The interim analysis of single dose cohorts produced a half-life estimate of greater than 71 days, which is in line with expectations from the 23-day half-life in non-human primates and scaling metrics for half-life extended antibodies.

药代动力学：单剂量队列的中期分析得出的半衰期估计超过71天，这与非人灵长类动物中23天的半衰期以及延长半衰期抗体的缩放指标相符。

Pharmacodynamics: Consistent with XmAb942’s high-potency and extended exposure design, large and durable dose-dependent increases of

药效学：与XmAb942的高效性和延长暴露设计一致，大幅且持久的剂量依赖性增加

total TL1A

总TL1A

in circulation were observed in both IV and SC cohorts. Circulating

在静脉注射和皮下注射队列中均观察到循环中的情况。循环

free TL1A

游离TL1A

was reduced significantly compared to placebo for all cohorts.

与安慰剂相比，所有队列均显著减少。

Immunogenicity: Early pharmacokinetic analysis of single and multiple dose cohorts shows no apparent evidence of anti-drug antibodies emerging against XmAb942.

免疫原性：对单剂量和多剂量队列的早期药代动力学分析显示，没有明显证据表明出现了针对XmAb942的抗药物抗体。

XENITH-UC: Phase 2b Study in Ulcerative Colitis (UC)

XENITH-UC：溃疡性结肠炎（UC）的 2b 期研究

The Phase 2b study of XmAb942 in UC (XENITH-UC) will be a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severely active UC, whose disease has progressed after at least one conventional or advanced therapy. XmAb942 will be administered intravenously during the 12-week induction period and subcutaneously every 12 weeks during the maintenance period.

XmAb942在UC中的二期b阶段研究（XENITH-UC）将是一项随机、双盲、安慰剂对照试验，针对中度至重度活动性UC患者，这些患者的疾病在至少一种常规或高级治疗后有所进展。XmAb942将在12周的诱导期内通过静脉注射给药，并在维持期间每12周皮下注射一次。

The primary endpoint of the study will be clinical remission based on the modified Mayo score at week 12. The study is designed to enroll approximately 220 patients across three induction dose levels and powered to enable Phase 3 dose selection. XENITH-UC is expected to start in the second half of 2025..

本研究的主要终点是基于改良Mayo评分的第12周临床缓解。研究设计预计招募约220名患者，涵盖三个诱导剂量水平，并为第三阶段剂量选择提供依据。XENITH-UC预计将于2025年下半年启动。

Conference Call and Webcast

电话会议和网络直播

Xencor

Xencor

will host a conference call and webcast today at

今天将举办电话会议和网络直播

5:00 p.m. ET

下午5:00（东部时间）

(

(

2:00 p.m. PT

下午2点（太平洋时间）

) to review the interim results outlined in this news release. The live webcast of the conference call may be accessed through

）来审查本新闻稿中概述的中期结果。电话会议的现场网络直播可以通过以下方式访问

this link

此链接

and through “Events & Presentations” in the Investors section of the Company’s website, located at

并通过公司网站投资者部分的“活动与演示”栏目，位于

investors.xencor.com

投资者.xencor.com

. A recording will be available for at least 30 days.

录音将至少保留30天。

About XmAb942

关于XmAb942

XmAb942 is a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD). The first generation of anti-TL1A antibodies, designed to block the interaction between the DR3 receptor and its ligand TL1A, have reduced disease activity in patients with UC and CD in multiple clinical studies.

XmAb942 是一种高效、半衰期延长的研究性抗 TL1A 抗体，正在开发用于治疗炎症性肠病 (IBD) 患者，例如溃疡性结肠炎 (UC) 和克罗恩病 (CD)。第一代抗 TL1A 抗体旨在阻断 DR3 受体与其配体 TL1A 的相互作用，在多项临床研究中已显示出能够降低 UC 和 CD 患者的疾病活动度。

Interim results from a Phase 1 dose-escalation study in healthy volunteers indicate that XmAb942 is well tolerated at single and multiple doses. Pharmacokinetic analysis of the single dose cohorts estimates a human half-life of greater than 71 days for XmAb942, which supports a 12-week dosing interval during maintenance treatment..

一项在健康志愿者中进行的1期剂量递增研究的中期结果表明，XmAb942在单次和多次剂量下均具有良好的耐受性。对单剂量组的药代动力学分析估计，XmAb942的人体半衰期超过71天，这支持在维持治疗期间采用12周的给药间隔。

About

关于

Xencor

Xencor

Xencor

Xencor

is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with

是一家临床阶段的生物制药公司，开发用于治疗癌症和自身免疫性疾病患者的工程抗体。拥有超过20个经过工程改造的候选药物

Xencor's

Xencor的

XmAb® technology are in clinical development, and multiple XmAb medicines are marketed by partners.

XmAb® 技术正在临床开发中，多个 XmAb 药物已由合作伙伴上市销售。

Xencor's

Xencor的

XmAb engineering technology enables small changes to a protein’s structure that result in new mechanisms of therapeutic action. For more information, please visit

XmAb工程技术通过改变蛋白质结构实现新的治疗机制。欲了解更多信息，请访问

www.xencor.com

www.xencor.com

.

。

Forward-Looking Statements

前瞻性声明

Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “indicates,” “supports,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding expectations for clinical progress, planned presentations of clinical data, new XmAb candidates and programs, planned and in process clinical trials, the quotations from .

本新闻稿中包含的某些陈述可能会构成适用证券法意义上的前瞻性陈述。前瞻性陈述包括并非纯粹历史事实的陈述，通常可以通过使用诸如“潜在”、“可能”、“将”、“计划”、“可以”、“能够”、“会”、“预期”、“预计”、“寻求”、“展望”、“相信”、“承诺”、“研究性”、“表明”、“支持”等词语，或通过与Xencor业务相关的明确或隐含讨论来识别，包括但不限于关于临床进展预期、临床数据展示计划、新的XmAb候选药物和项目、计划中或进行中的临床试验以及相关引述的陈述。

Xencor's

Xencor的

president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of

总裁兼首席执行官，以及其他并非纯粹历史事实的陈述。这些陈述是基于管理层当前的信念、期望和假设作出的。

Xencor

Xencor公司

and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results.

并且受到重大已知和未知风险、不确定性及其他因素的影响，这些因素可能导致实际结果、表现或成就以及事件的时间与这些陈述所暗示的内容存在重大差异，因此这些陈述不应被视为未来表现或结果的保证。

Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments and the risks, uncertainties and other factors described under the heading “Risk Factors” in .

此类风险包括但不限于与发现、开发、制造和商业化用作人类治疗药物的安全性和有效性相关的风险，以及其他风险，包括公开披露的初步临床试验数据是否足以支持特定治疗的持续临床开发和监管审批，以及“风险因素”标题下描述的风险、不确定性和其他因素。

Xencor's

Xencor的

annual report on Form 10-K for the year ended

截至某年的年度报告 Form 10-K

December 31, 2024

2024年12月31日

as well as

以及

Xencor's

Xencor的

subsequent filings with the

随后的文件提交给

Securities and Exchange Commission

证券交易委员会

. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and .

您被提醒不要对这些前瞻性陈述给予过分依赖，这些陈述仅截至本文件发布之日有效。此警告依据1995年《私人证券诉讼改革法案》的安全港条款作出，并已根据最新情况进行修订。所有前瞻性陈述均受此警示声明的全面约束。

Xencor

Xencor公司

undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

不承担修订或更新这些前瞻性陈述以反映自本日期之后的事件或情况的义务，除非法律要求。

View source version on

查看源版本

businesswire.com

业务连线.com

:

：

https://www.businesswire.com/news/home/20250429473803/en/

https://www.businesswire.com/news/home/20250429473803/zh/

For Investors:

对于投资者：

Charles Liles

查尔斯·莱尔斯

cliles@xencor.com

cliles@xencor.com

(626) 737-8118

(626) 737-8118

For Media:

媒体：

Cassidy McClain

凯西迪·麦克莱恩

Inizio Evoke

开始唤起

cassidy.mcclain@inizioevoke.com

cassidy.mcclain@inizioevoke.com

(619) 694-6291

(619) 694-6291

Source:

源代码：

Xencor, Inc.

Xencor公司