免疫肿瘤学公司宣布在2025年ASCO上公布下一代CD47抗体“IMC-002”1b期临床试验的中期结果-动脉网

ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025

CISION 等信源发布 2025-06-03 02:30

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CHICAGO

芝加哥

，

June 2, 2025

2025年6月2日

/PRNewswire/ -- ImmuneOncia Therapeutics, Inc. (CEO

/PRNewswire/ -- ImmuneOncia Therapeutics, Inc.（首席执行官

Heung-Tae Kim

金兴泰

) announced interim results today from the ongoing Phase

）今天公布了正在进行的第二阶段的中期结果

clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC). The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in

IMC-002是一种下一代靶向CD47的抗体，与仑伐替尼联合用于晚期肝细胞癌（HCC）患者的临床试验。数据在2025年美国临床肿瘤学会（ASCO）年会上公布。

Chicago

芝加哥

，

USA

美国

。

The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anemia was observed in 2 of 13 patients (15%), and 96% of adverse events were Grade 1–2, occurring primarily in the first treatment cycle..

该研究是剂量扩展阶段的一部分，评估了联合疗法的安全性和早期疗效。IMC-002表现出良好的安全性，未报告中性粒细胞减少或血小板减少的病例。在13名患者中有2名（15%）观察到轻度贫血，96%的不良事件为1-2级，主要发生在第一个治疗周期。

Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit..

在可评估疗效的10名患者中，3名（30%）患者出现部分缓解（PR），而疾病控制率（DCR）达到了80%。中位无进展生存期（PFS）为8.3个月。值得注意的是，两名患者持续接受治疗已超过一年，显示出持续治疗获益的潜力。

AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumor cell membranes, whereas no response was observed in those with low expression - a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response..

人工智能驱动的数字病理分析显示，在肿瘤细胞膜上CD47高表达的患者中，客观缓解率（ORR）为60%，而在低表达的患者中未观察到缓解——这一差异具有统计学显著性（p=0.018）。这些发现支持CD47表达可作为反应的预测性生物标志物。

Professor

教授

Jeong-Yong Hong

洪正勇

of Samsung Medical Center commented, 'The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives. A 30% response rate is particularly promising, especially when compared to the approximately 10% typically observed with current second-line therapies for HCC.'.

三星医疗中心评论道：“IMC-002 和乐伐替尼的组合显示出作为肝癌患者的二线治疗选择的强大潜力，对于这些患者而言，治疗选择十分有限。30% 的应答率尤其令人鼓舞，特别是相较于目前肝癌二线疗法通常仅约 10% 的应答率。”

CEO

首席执行官

Heung-Tae Kim

金兴泰

stated, 'Two of the three partial responders were resistant to first-line immunotherapy, suggesting IMC-002 may offer a new path forward via macrophage-based innate immunity. We are confident that this combination could redefine second-line treatment for HCC and will enhance our patient selection strategy through AI-driven biomarker analysis.'.

表示：“三名部分缓解者中有两名对一线免疫治疗耐药，这表明 IMC-002 可能通过基于巨噬细胞的先天免疫提供一条新路径。我们相信这种组合可以重新定义肝癌的二线治疗，并通过人工智能驱动的生物标志物分析加强我们的患者选择策略。”

IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimize binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia.

IMC-002是一种针对CD47-SIRPα轴的IgG4单克隆抗体，可恢复巨噬细胞介导的癌细胞吞噬作用。它是一种第二代抗CD47抗体，旨在减少与正常细胞的结合，避免常见的毒性如红细胞凝集和细胞减少症。

ImmuneOncia is currently conducting Phase

ImmuneOncia 目前正在进行第

trial of IMC-002 in patients with solid tumors. In 2021, the company out-licensed the asset to

IMC-002在实体瘤患者中的试验。2021年，该公司将该资产授权给了

China's

中国的

3D Medicines in a deal worth up to

三生制药达成了一项价值高达

$470 million

4.7亿美元

. Its pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202. Following its KOSDAQ listing in

其研发管线还包括PD-L1抗体IMC-001和双特异性抗体IMC-201及IMC-202。在其于KOSDAQ上市后，

May 2025

2025年5月

, ImmuneOncia aims to strengthen its global presence in immuno-oncology.

，ImmuneOncia 旨在加强其在免疫肿瘤学领域的全球影响力。

About IMC-002

关于IMC-002

IMC-002 is a novel immune checkpoint inhibitor targeting CD47, a 'don't eat me' signal expressed on cancer cells. By blocking the CD47/SIRPα interaction, IMC-002 enhances macrophage-mediated phagocytosis. It is engineered to deliver high efficacy while minimizing binding to red blood cells and avoiding hematologic toxicity..

IMC-002是一种新型的免疫检查点抑制剂，靶向CD47，这是癌细胞表达的一种“别吃我”信号。通过阻断CD47/SIRPα相互作用，IMC-002增强了巨噬细胞介导的吞噬作用。它被设计为在提供高效力的同时，尽量减少与红细胞的结合并避免血液毒性。

About ImmuneOncia Therapeutics, Inc.

关于ImmuneOncia Therapeutics, Inc.

Founded in 2016, ImmuneOncia is a South Korean clinical-stage biotech company specializing in immuno-oncology. With expertise in antibody development and translational science, the company is advancing a pipeline of checkpoint inhibitors and bispecific antibodies to address unmet needs in cancer treatment..

成立于2016年，ImmuneOncia是一家韩国临床阶段的生物技术公司，专注于免疫肿瘤学。凭借在抗体开发和转化科学方面的专业知识，该公司正在推进一系列检查点抑制剂和双特异性抗体的研发，以满足癌症治疗中未被满足的需求。

Media Contact

媒体联系人

Jiwon Heo

许智媛

ImmuneOncia Therapeutics, Inc.

免疫肿瘤学治疗公司

Email:

电子邮件：

PR@immuneoncia.com

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