WATERTOWN, Mass. and GOSSELIES, Belgium, July 08, 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, today announced the dosing of the first patient in GALAXIES Lung-301, a global, randomized, double-blind Phase 3 registrational clinical trial of belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC.

马萨诸塞州沃特敦和比利时戈塞利斯，2024年7月8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治疗剂，今天宣布在GALAXIES Lung-301中给药第一名患者，这是belrestotug+dostarlimab与安慰剂+pembrolizumab在一线晚期，不可切除或转移性PD-L1高NSCLC患者中的全球随机双盲3期注册临床试验。

This event has triggered $35 million in development milestone payments from GSK, its partner for belrestotug..

此次活动已从其belrestotug的合作伙伴GSK获得3500万美元的开发里程碑付款。。

“Dosing the first patient in the GALAXIES Lung-301 study marks a significant milestone for belrestotug + dostarlimab. iTeos was founded with the goal of advancing therapeutic options for patients by leveraging best-in-class science. The decision to launch our first TIGIT:PD-1 doublet Phase 3 trial underscores our disciplined, data-driven investment approach and was informed by several promising preliminary clinical surrogates such as safety, ORR, and depth of response from the latest interim analysis in May 2024,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos.

iTeos总裁兼首席执行官米歇尔·德修斯（Michel Detheux）博士表示：“为GALAXIES Lung-301研究中的第一名患者进行给药，标志着belrestotug+dostarlimab的一个重要里程碑。iTeos成立的目的是通过利用一流的科学来推进患者的治疗选择。启动我们的第一个TIGIT:PD-1 doublet 3期试验的决定强调了我们严格的数据驱动投资方法，并从2024年5月的最新中期分析中获得了一些有前途的初步临床替代指标，如安全性，ORR和反应深度。”。

“We are excited about the ongoing Phase 2 GALAXIES Lung-201 trial and look forward to presenting data from the most recent interim analysis of this study at a medical meeting in 2024.”.

“我们对正在进行的第二阶段GALAYS Lung-201试验感到兴奋，并期待着在2024年的医学会议上提供这项研究的最新中期分析数据。”。

iTeos and GSK entered into an exclusive development and commercialization collaboration in June 2021 for belrestotug, an anti-TIGIT monoclonal antibody, enabling novel next-generation immuno-oncology combinations. Per the agreement, iTeos received a $625 million upfront payment from GSK with development and regulatory milestones up to $550 million and commercial milestones up to $900 million.

iTeos和GSK于2021年6月就抗TIGIT单克隆抗体belrestotug进行了独家开发和商业化合作，从而实现了新一代免疫肿瘤学组合。根据该协议，iTeos从GSK获得了6.25亿美元的预付款，其中开发和监管里程碑高达5.5亿美元，商业里程碑高达9亿美元。

In addition to the milestones, GSK and iTeos will jointly commercialize and equally split profits in the US. Outside the US, GSK will receive an exclusive license for commercialization and iTeos will receive tiered royalty payments. Within the collaboration, GSK and iTeos share responsibility and costs for the global development of belrestotug..

除了里程碑之外，葛兰素史克和iTeos将在美国共同商业化并平均分配利润。在美国以外，葛兰素史克将获得商业化的独家许可，iTeos将获得分层版税。在合作范围内，GSK和iTeos为belrestotug的全球开发分担责任和成本。。

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（ADCC）的免疫应答的关键调节剂。

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。。