WATERTOWN, Mass. and GOSSELIES, Belgium, June 17, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC)..

马萨诸塞州沃特敦和比利时戈塞利斯，2024年6月17日（环球通讯社）--iTeos Therapeutics，Inc.（纳斯达克：ITOS）（“iTeos”），一家临床阶段的生物制药公司，率先发现和开发新一代患者免疫肿瘤学治疗剂，及其开发合作伙伴GSK，已经启动了belrestotug+dostarlimab doublet与安慰剂+pembrolizumab在先前未经治疗，不可切除，局部晚期或转移性PD-L1选择的非小细胞肺癌（NSCLC）患者中的首个全球3期注册研究。。

“With the initiation of the first Phase 3 study for belrestotug, we are entering a monumental stage in our journey to develop a world-leading oncology company. Nearly 70% of patients with first-line PD-L1 high non-small cell lung cancer rely upon a chemotherapy-free regimen. We believe belrestotug + dostarlimab are poised to potentially advance the therapeutic regimen in this setting and establish new benchmarks,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos.

iTeos总裁兼首席执行官Michel Detheux博士说：“随着belrestotug第一阶段3期研究的启动，我们正在进入一个里程碑式的阶段，以发展一家世界领先的肿瘤公司。近70%的一线PD-L1高非小细胞肺癌患者依赖无化疗方案。我们相信belrestotug+dostarlimab有望在这种情况下推进治疗方案，并建立新的基准。”。

“Based on our high-quality doublet exceeding its pre-defined efficacy criteria for clinically relevant activity in an interim assessment from the Phase 2 GALAXIES Lung-201 study, we believe initiating the Phase 3 program with this patient population will serve as the foundation to our broader strategy and marks our first step in building a franchise.”.

“基于我们在第二阶段GALAXIES Lung-201研究的中期评估中超过其临床相关活动预定义疗效标准的高质量双峰，我们相信针对该患者群体启动第三阶段计划将成为我们更广泛战略的基础，标志着我们建立特许经营权的第一步。”。

The randomized, double-blind, placebo-controlled, multicenter trial will enroll approximately 1,000 patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC in North America, South America, Europe and Asia. The primary endpoints of the trial are progression free survival and overall survival.

这项随机，双盲，安慰剂对照的多中心试验将在北美，南美，欧洲和亚洲招募约1000名先前未经治疗，不可切除，局部晚期或转移性PD-L1选择的NSCLC患者。该试验的主要终点是无进展生存期和总生存期。

In the GALAXIES Lung-301 trial, patients will be randomized 1:1 to either an intravenous infusion of the belrestotug + dostarlimab doublet or placebo + pembrolizumab..

在GALAYS Lung-301试验中，患者将以1:1的比例随机接受静脉输注belrestotug+dostarlimab doublet或安慰剂+pembrolizumab。。

In May 2024, iTeos announced an interim assessment of the Phase 2 GALAXIES Lung-201 study of the belrestotug + dostarlimab doublet in previously untreated, locally advanced, or metastatic PD-L1 selected NSCLC exceeded pre-defined efficacy criteria for clinically relevant activity and showed an acceptable safety profile in line with the TIGIT:PD-1 class.

2024年5月，iTeos宣布对先前未经治疗，局部晚期或转移性PD-L1选择的NSCLC中belrestotug+dostarlimab双峰的2期GALAXIES Lung-201研究进行中期评估，超过了临床相关活动的预定义疗效标准，并显示出符合TIGIT:PD-1类的可接受安全性。

Clinically meaningful tumor reduction was observed at every belrestotug + dostarlimab dose vs dostarlimab monotherapy..

在每个belrestotug+dostarlimab剂量与dostarlimab单药治疗中观察到临床上有意义的肿瘤减少。。

About iTeos Therapeutics, Inc.

关于iTeos Therapeutics，Inc。

iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer.

iTeos Therapeutics是一家临床阶段的生物制药公司，开创了新一代免疫肿瘤治疗药物的发现和开发。iTeos Therapeutics利用其对肿瘤免疫学和免疫抑制途径的深入了解，设计出具有恢复癌症免疫反应潜力的新型候选产品。

The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium..

该公司的创新管道包括三个临床阶段计划，针对新颖的，经过验证的免疫抑制途径，设计了优化的药理学特性，以改善临床结果，包括TIGIT/CD226轴和腺苷途径。iTeos Therapeutics总部位于马萨诸塞州沃特敦，在比利时戈塞利斯设有一个研究中心。。

About Belrestotug (EOS-448/ GSK4428859A)

关于贝尔雷斯托格（EOS-448/GSK428859A）

Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate immune responses against cancer.

Belrestotug是一种Fc活性人免疫球蛋白G1或IgG1单克隆抗体（mAb），靶向T细胞免疫球蛋白和基于免疫受体酪氨酸的抑制性基序结构域（TIGIT），这是一种重要的抑制性受体，有助于抑制针对癌症的先天免疫应答。

As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC).

作为一种优化的高亲和力，有效的抗TIGIT单克隆抗体，belrestotug旨在通过与TIGIT和FcγR结合，通过多方面的免疫调节机制增强抗肿瘤反应，FcγR是诱导细胞因子释放和抗体依赖性细胞毒性的免疫应答的关键调节剂（ADCC）。

The therapeutic candidate is progressing in multiple indications in collaboration with GSK..

该治疗候选人与GSK合作在多种适应症方面取得了进展。。

Internet Posting of Information

网上发布信息

iTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos.

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Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements.

本新闻稿包含前瞻性声明。任何不只是历史事实陈述的陈述都是前瞻性陈述。诸如“相信”、“预期”、“计划”、“预期”、“将”、“可能”、“打算”、“准备”、“展望”、“潜力”、“可能”等词语以及类似的表达方式旨在识别前瞻性陈述。

These forward-looking statements include statements relating to our belief that belrestotug + dostarlimab are poised to potentially advance the therapeutic regimen in the first-line PD-L1 high non-small cell lung cancer setting and establish new benchmarks; and our belief that initiating the Phase 3 program with this patient population will serve as the foundation to our broader strategy and building a franchise..

这些前瞻性声明包括与我们相信belrestotug+dostarlimab有望在一线PD-L1高非小细胞肺癌治疗方案中取得潜在进展并建立新的基准有关的声明；我们相信，针对这一患者群体启动第三阶段计划将成为我们更广泛战略和建立特许经营权的基础。。

These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: success in early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; interim and early data may change as more patient data become available and are subject to audit and verification procedures; the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize due to a variety of reasons, including challenges and uncertainties inherent in product research and development and manufacturing limitations; and those risks identified under the heading “Risk Factors” in iTeos’ Quarterly Report on Form 10-Q for the period ended March 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review..

这些前瞻性陈述涉及风险和不确定性，其中许多超出了iTeos的控制范围。由于此类风险和不确定性，实际结果可能与这些前瞻性声明所述或暗示的结果存在重大差异。已知的风险因素包括：早期临床试验的成功并不能确保后期临床试验的成功，临床试验的早期结果不一定能预测最终结果；随着越来越多的患者数据可用并接受审计和验证程序，临时和早期数据可能会发生变化；由于各种原因，包括产品研发和制造限制固有的挑战和不确定性，与iTeos和GSK之间的协议相关的预期利益和机会可能无法实现，或者可能需要更长的时间才能实现；以及iTeos向美国证券交易委员会（SEC）提交的截至2024年3月31日的表10-Q季度报告中“风险因素”标题下确定的风险，以及该公司提交的其他SEC文件，鼓励您审查。。

Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law..

。我们提醒投资者不要过度依赖本新闻稿中的前瞻性声明。除法律要求外，iTeos不承担公开更新其前瞻性声明的任何义务。。

For further information, please contact:

欲了解更多信息，请联系：

Investor Contact:

投资者联系人：

Carl Mauch

卡尔·莫奇

iTeos Therapeutics, Inc.

iTeos治疗公司。

carl.mauch@iteostherapeutics.com

carl.mauch@iteostherapeutics.com

Media Contact:

媒体联系人：

media@iteostherapeutics.com

media@iteostherapeutics.com