马伦戈将在即将到来的2025年AACR临床全体口头报告中，分享STARt-001一期/二期临床试验的更新结果，重点介绍Invikafusp Alfa单药治疗在PD1耐药肿瘤中的活性-动脉网

Marengo to Share Updated Clinical Results from STARt-001 Phase 1/2 Clinical Trial Featuring Invikafusp Alfa Monotherapy Activity in PD1 Resistant Tumors at Upcoming AACR 2025 Clinical Plenary Oral Presentation

CISION 等信源发布 2025-04-26 00:59

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可切换为仅中文

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Initial disease control rate of 67%, tumor regression rate of 44% and preliminary objective response rate of 22% were observed in TMB-H patients at the optimal biological dose range

在最佳生物剂量范围内的TMB-H患者中，观察到初始疾病控制率为67%，肿瘤退缩率为44%，初步客观缓解率为22%。

Invikafusp alfa (STAR0602) demonstrates pan-tumor selective Vβ T cell expansion in vivo across 18 different solid tumor types

Invikafusp alfa (STAR0602) 在18种不同的实体瘤类型中显示出泛肿瘤选择性Vβ T细胞扩增。

Data highlight promising anti-tumor activity as single agent in heavily pretreated anti-PD(L)1 resistant tumors including both primary and secondary resistant patients

数据突显了在多线治疗后抗PD(L)1耐药的肿瘤中，作为单药治疗的有希望的抗肿瘤活性，包括原发性和继发性耐药患者。

CAMBRIDGE, Mass.

马萨诸塞州剑桥市

，

April 25, 2025

2025年4月25日

/PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, today announced an upcoming clinical plenary oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025. The presentation will report updated clinical and translational findings from the ongoing Phase 1/2 trial (STARt-001) evaluating invikafusp alfa (STAR0602) in patients with anti-PD(L)1-resistant, antigen-rich solid tumors..

/PRNewswire/ -- Marengo Therapeutics, Inc.是一家临床阶段的生物技术公司，致力于开创精准免疫治疗的新方法，今天宣布将在2025年美国癌症研究协会（AACR）年会上进行一场临床全体口头报告。该报告将提供正在进行的1/2期试验（STARt-001）的更新临床和转化研究结果，该试验评估了invikafusp alfa（STAR0602）在抗PD(L)1耐药、富含抗原的实体瘤患者中的效果。

The results highlight clinical pharmacology, selective immune activation, and RP2D selection in addition to demonstrating clinically meaningful anti-tumor activity and a well-characterized safety profile. The data also further support the advancement of the lead asset into Phase 2 development and confirm clinical efficacy..

结果突显了临床药理学、选择性免疫激活和RP2D选择，此外还展示了具有临床意义的抗肿瘤活性和良好特征的安全性。数据还进一步支持了将主要资产推进到第二阶段开发，并确认了临床疗效。

'These encouraging data represent the first clinical proof of our precision T cell agonist approach to overcome anti-PD(L)1-resistant cancer, a therapeutic area with significant unmet need. Importantly, invikafusp monotherapy not only selectively engaged and expanded a key T cell subset in immunotherapy-resistant tumors, but also reinvigorated anti-tumor responses,' said .

“这些令人鼓舞的数据代表了我们精准T细胞激动剂方法克服抗PD(L)1耐药癌症的首个临床验证，这是一个存在显著未满足需求的治疗领域。重要的是，invikafusp单药治疗不仅选择性地激活并扩增了免疫治疗耐药肿瘤中的关键T细胞亚群，还重新激发了抗肿瘤反应。”

Ke Liu

刘可

, M.D. Ph.D., Chief Development Officer of Marengo Therapeutics. 'Based on the initial disease control and tumor regression rates observed, invikafusp has the potential to offer a promising new class of immunotherapy for patients who have exhausted checkpoint inhibitor therapy options.'

医学博士， Marengo Therapeutics公司的首席发展官表示：“基于最初观察到的疾病控制和肿瘤消退率，invikafusp有可能为那些已经用尽检查点抑制剂疗法选择的患者提供一种有前景的新型免疫疗法。”

'The initial clinical activity of invikafusp monotherapy in PD-1 resistant tumors is novel and important as a new approach to immunotherapy,' said

“Invikafusp单药治疗在PD-1耐药肿瘤中的初步临床活性作为一种新的免疫治疗方法，具有新颖且重要的意义，”表示

Bruce A. Chabner

布鲁斯·A·查布纳

, M.D., Clinical Director Emeritus at Massachusetts General Hospital. 'The ability of invikafusp to activate a specific subset of T cells in heavily pretreated cancer patients and achieve objective responses in tumors that have failed PD-1 inhibitors is clinically meaningful. These results may mark the beginning of a new class of novel T cell agonists in treating checkpoint resistant cancers with precision immune activation.'.

，麻省总医院临床主任医师。 “Invikafusp能够在经过多次预处理的癌症患者中激活特定的T细胞亚群，并在对PD-1抑制剂失效的肿瘤中取得客观反应，这在临床上是有意义的。这些结果可能标志着一类新的T细胞激动剂的开始，可以精确地激活免疫系统来治疗对检查点抑制剂耐药的癌症。”

Invikafusp alfa is Marengo's first-in-class, dual T cell agonist with a bi-specific antibody design to selectively activate the Vβ6 and Vβ10 subsets of T cells

Invikafusp alfa 是 Marengo 的首创双 T 细胞激动剂，具有双特异性抗体设计，可选择性激活 T 细胞的 Vβ6 和 Vβ10 亚群。

in vivo

体内

。

Key Findings from the Abstract (CT205):

摘要的主要发现（CT205）：

Initial Clinical Activity (TMB-H subgroup at optimal biologic dose):

初始临床活性（TMB-H亚组在最佳生物剂量下）：

Six of the initial nine efficacy evaluable patients (67%) achieved disease control (2 confirmed partial responses (cPRs) and 4 with stable disease)

初始九名可评估疗效的患者中有六名（67%）实现了疾病控制（2例确认的部分缓解（cPR）和4例病情稳定）。

The cPRs were in MSS colorectal cancer with one response lasting ~12 months

cPRs见于MSS型结直肠癌，其中一种反应持续约12个月。

Plenary oral presentation to include updated clinical results from initial data cut and additional patients

全体口头报告，包括初始数据截取的更新临床结果和更多患者信息

Clinical Pharmacology and Recommended Phase 2 Dose (RP2D):

临床药理学和推荐的二期剂量（RP2D）：

RP2D was determined as 0.08 mg/kg Q2W, selected based on pharmacokinetics, pharmacodynamics, safety, and activity

RP2D 被确定为 0.08 mg/kg Q2W，此剂量是基于药代动力学、药效学、安全性和活性选择的。

Dose-dependent, selective expansion of peripheral CD8

剂量依赖性，外周CD8选择性扩增

加号

Vβ6/Vβ10 T cells, with ~600% average peak expansion at RP2D

Vβ6/Vβ10 T细胞，在RP2D时平均峰值扩增约600%

Expanded Vβ T cells exhibited a memory phenotype and expressed cytotoxic effector molecules

扩增的 Vβ T 细胞表现出记忆表型并表达细胞毒效应分子

Soluble markers of T cell activation (e.g., IFN-γ, sCD25) increased post-dosing; inflammatory cytokines (e.g., TNF-α, IL-6) remained limited below RP2D

T细胞激活的可溶性标志物（如IFN-γ、sCD25）在给药后增加；炎症细胞因子（如TNF-α、IL-6）在RP2D以下保持较低水平。

Based on initial clinical and preclinical results, the U.S. Food and Drug Administration granted

基于初步的临床和临床前结果，美国食品和药物管理局授予了

Fast Track Designation

快速通道指定

to invikafusp alfa for the treatment of patients with TMB-high colorectal cancer. The STARt-001 Phase 2 portion of the trial is ongoing and actively enrolling, focused on expanding into other antigen-rich tumors, including MSI-H and TMB-H tissue agnostic solid tumors.

针对TMB高的结直肠癌患者使用invikafusp alfa进行治疗。试验的STARt-001第二阶段部分正在进行中，并在积极招募患者，重点是扩展到其他富含抗原的肿瘤，包括MSI-H和TMB-H组织不可知的实体瘤。

Presentation Details

演示详情

Title

标题

: Updated clinical results, recommended Phase 2 dose (RP2D) determination and translational study results for START-001: a Phase 1/2 trial of invikafusp alfa, a first-in-class TCR β chain-targeted bispecific antibody in patients with anti-PD(L)1-resistant, antigen-rich solid tumors

START-001 的更新临床结果、推荐的二期剂量（RP2D）确定和转化研究结果：invikafusp alfa（一种针对 TCR β 链的双特异性抗体）在抗 PD(L)1 抵抗、富含抗原的实体瘤患者中的 1/2 期试验。

Abstract Number

摘要编号

: CT205 (Late-breaking)

：CT205（最新突破）

Session Title

会议标题

: Clinical Trials Plenary: Biologics and T-cell Engagers

临床试验全体会议：生物制剂和T细胞结合剂

Session Date and Time

会话日期和时间

：

Tuesday, April 29, 2025

2025年4月29日，星期二

，

10:15 AM

上午10点15分

–

12:15 PM CT

中午12点15分（中部时间）

Presenter

主持人

：

Ryan J. Sullivan

瑞安·J·沙利文

, M.D., Massachusetts General Hospital

，医学博士，麻省总医院

About Marengo Therapeutics

关于马伦戈治疗公司

Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone's immune system can defeat cancer and autoimmune diseases.

马伦戈治疗公司（Marengo Therapeutics, Inc.）是一家临床阶段的生物技术公司，致力于开发新型靶向TCR的抗体，这些抗体能够选择性调节种系TCR库中常见和疾病特异性的T细胞亚群，从而为癌症和自身免疫性疾病提供终身保护。凭借一支充满热情、在免疫学和肿瘤学领域经验丰富的科学家团队，以及三大专有平台——选择性T细胞激活谱（STAR）、三特异性T细胞接合器（Tri-STAR）和T细胞清除剂（MSTAR），马伦戈正努力在合适的患者中精准靶向正确的T细胞，旨在创造一个每个人免疫系统都能战胜癌症和自身免疫疾病的世界。

To learn more, visit marengotx.com..

要了解更多信息，请访问 marengotx.com。

About the STAR™ Platform

关于STAR™平台

Marengo's STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo's proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses..

Marengo的STAR™平台是一个多特异性抗体融合平台，源自Marengo专有的抗体库，这些抗体靶向TCR的种系编码可变Vβ区域，并与不同的T细胞共刺激部分融合。将一种新型的非克隆型TCR激活模式与同一分子中的T细胞共刺激因子相结合，促进了一种独特的作用机制，从而激发持久的抗肿瘤Vβ T细胞反应。

About Invikafusp alfa (STAR0602)

关于Invikafusp alfa（STAR0602）

Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance.

Invikafusp alfa（STAR0602）是Marengo公司STAR™平台的先导候选药物。它通过将非克隆型TCR激活模式与T细胞共刺激信号结合在一个单分子中，选择性激活存在于所有癌症中的一种常见Vβ T细胞亚群。这种创新方法促进克隆多样性、效应记忆型Vβ T细胞的扩增，增强抗肿瘤免疫能力，并实现持久的肿瘤清除。

Extensive preclinical studies demonstrate STAR0602's potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action. .

广泛的临床前研究显示，STAR0602通过一种新颖的作用机制，在小鼠和人类离体模型中均表现出强大的抗肿瘤活性。

About the STARt-001 Clinical Study

关于STARt-001临床研究

STARt-001 is a Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary efficacy of invikafusp alfa as a monotherapy in biomarker-selected patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumor types. The trial consists of two parts: Phase 1 dose escalation and Phase 2 dose expansion.

STARt-001是一项1/2期临床试验，评估invikafusp alfa作为单药治疗在生物标志物筛选的晚期抗原丰富实体瘤患者中的安全性、耐受性和初步疗效，包括对PD-1耐药和罕见肿瘤类型。该试验分为两部分：1期剂量递增和2期剂量扩展。

For more information, visit .

欲了解更多信息，请访问。

clinicaltrials.gov

临床试验.gov

(Identifier: NCT05592626).

（标识符：NCT05592626）。

Patients interested in participating in this study at the National Cancer Institute (NCI) can contact NCI's toll-free number: 1-800-4-CANCER (1-800-422-6237) (TTY: 1-800-332-8615), visit the website at

有兴趣在国家癌症研究所 (NCI) 参与本研究的患者可以联系 NCI 的免费电话：1-800-4-CANCER（1-800-422-6237）（TTY：1-800-332-8615），或访问网站

https://trials.cancer.gov

, or email

，或者电子邮件

NCIMO_referrals@mail.nih.gov

。

Marengo Contacts:

马伦戈联系人：

Media

媒体

Peg Rusconi

佩格·鲁斯科尼