The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies:
* Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.
* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.
* Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.

开始日期2025-04-28

申办/合作机构

ALX Oncology, Inc.

NCT05467670

/ Recruiting临床2期IIT

Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Patients with Recurrent Platinum-resistant Ovarian Cancer: Phase II Study

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

开始日期2023-03-30

申办/合作机构

University of Pittsburgh

[+2]

NCT05868226

/ Recruiting临床1期

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

开始日期2023-02-15

申办/合作机构

Quantumleap Healthcare Collaborative

100 项与 Evorpacept 相关的临床结果

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100 项与 Evorpacept 相关的转化医学

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100 项与 Evorpacept 相关的专利（医药）

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项与 Evorpacept 相关的文献（医药）

2024-07-01·CURRENT OPINION IN ONCOLOGY

State of the art and upcoming trends in HER2-directed therapies in gastrointestinal malignancies

Review

作者: Lee, Jaeyop ; Ku, Geoffrey

Purpose of review:

This review critically evaluates the evolution and current status of human epidermal growth factor receptor 2 (HER2)-directed therapies in upper gastrointestinal (GI) malignancies, a timely and relevant inquiry given the dynamic shifts in therapeutic strategies over the past decade. Initial enthusiasm following the Trastuzumab for Gastric Cancer (ToGA) study's demonstration of trastuzumab's efficacy, however, encountered hurdles due to subsequent trials showing limited progress, underscoring the necessity for a reevaluation of therapeutic approaches and the exploration of novel agents.

Recent findings:

The review highlights significant breakthroughs in the form of immune checkpoint inhibitors and innovative therapeutic technologies, which have redefined treatment paradigms and shown promising efficacy in HER2-positive cases. Emerging treatments such as trastuzumab deruxtecan (T-DXd), zanidatamab and evorpacept further illustrate the ongoing efforts to leverage unique mechanisms of action for improved HER2-positive antitumor activity.

Summary:

The advancements in HER2-directed therapies underscore a pivotal era in the management of upper GI malignancies. These developments not only reflect the profound impact of integrating novel therapeutic combinations but also highlight the critical role of ongoing research in overcoming resistance mechanisms and tailoring treatment to individual disease profiles.

2024-01-01·TRANSFUSION MEDICINE AND HEMOTHERAPY

Evorpacept-Induced Interference and Application of a Novel Mitigation Agent, Evo-NR, in Pretransfusion Testing

Article

作者: Yoon, Eungjun ; Kim, Tae Yeul ; Kim, Hyungsuk ; Cho, Duck

Introduction: Evorpacept is a CD47-blocking agent currently being developed for the treatment of various cancers. Interference by evorpacept in pretransfusion compatibility testing has been reported at limited plasma concentrations. Although various mitigation strategies have been proposed, none are practical. This in vitro study assessed evorpacept-induced interference at extended concentrations and investigated the capability of a novel mitigation agent, Evo-NR. Methods: Antibody screening tests were performed on evorpacept-spiked plasma with (anti-E and anti-Jk^a) or without alloantibodies at evorpacept concentrations up to 2,000 μg/mL using manual gel cards and automated analyzers. Evorpacept-coated red blood cells (RBCs) (rr [ce/ce], Fy[a+b−], S−s+) were tested by direct antiglobulin testing (DAT) and antigen typing using anti-Fy^b and anti-S reagents at indirect antiglobulin testing (IAT) phase. Evo-NR was used to resolve the interference in plasma and RBC samples. Flow cytometry was used to assess the mitigation effects. Results: Evorpacept-spiked plasma showed panreactive interference in antibody screening tests using manual gel cards (2+ to 3+) and automated analyzers (4+). A carryover effect was also observed in the automated analyzers. The use of a 3- to 6-fold molar excess of Evo-NR effectively resolved the interference in the plasma and enabled accurate alloantibody identification. Although the reduction in evorpacept binding to RBCs was identified via flow cytometry, Evo-NR was incapable of resolving the serologic interference observed in DAT and antigen typing at IAT phase. Discussion: Evorpacept showed constant panreactivity and a carryover effect at high concentrations. Evo-NR successfully resolved the interference in the plasma samples and could be considered a practical and efficient mitigation solution. Implementation of Evo-NR has the potential to support RBC transfusion for patients undergoing evorpacept treatment.

2021-12-01·The Lancet. Oncology1区 · 医学

Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study

1区 · 医学

Article

作者: Patricia LoRusso ; Hyun Cheol Chung ; Keun-Wook Lee ; Hong I Wan ; Nehal J Lakhani ; Pierre Squifflet ; Wells A Messersmith ; Justin F Gainor ; Yung-Jue Bang ; Jaume Pons ; Frank Stephen Hodi ; Won Seog Kim ; Laura Q M Chow ; Jeeyun Lee ; Sophia S Randolph ; Philip Fanning ; Feng Jin ; Rafael Santana-Davila ; Tracy C Kuo

BACKGROUND:

Both innate and adaptive immune responses are important components of anticancer immunity. The CD47-SIRPα interaction could represent an important pathway used by tumour cells to evade immune surveillance. We aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and anticancer activity of evorpacept (also known as ALX148), a high-affinity CD47-blocking protein with an inactive IgG Fc region in patients with solid tumours.

METHODS:

We did a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study at nine hospitals and one clinic in the USA and Korea. Eligible patients for the dose-escalation and safety lead-in phases were aged 18 years or older with histological or cytological diagnosis of advanced or metastatic solid tumours with no available standard therapy, measurable or unmeasurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status score of 0 or 1. In the dose-escalation phase, which used a 3 + 3 design, patients received intravenous evorpacept at either 0·3, 1, 3, or 10 mg/kg once per week in 21-day cycles, or 30 mg/kg once every other week in 28-day cycles. In the safety lead-in phase, patients were given the maximum tolerable dose of evorpacept from the dose-escalation phase plus either intravenous pembrolizumab (200 mg administered once every 3 weeks) or intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks). In the dose-expansion phase, additional patients aged 18 years or older with second-line or later-line advanced malignancies were enrolled into three parallel cohorts: those with head and neck squamous cell carcinoma (HNSCC) and those with non-small-cell lung cancer (NSCLC) were given the maximum tolerated dose of evorpacept plus intravenous pembrolizumab (200 mg administered once every 3 weeks), and patients with HER2-positive gastric or gastroesophageal junction cancer were given the maximum tolerated dose of evorpacept plus intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks) until disease progression, voluntary withdrawal from the study, or unacceptable toxicity. The primary endpoint was the maximum tolerated dose of evorpacept administered as a single agent and in combination with pembrolizumab or trastuzumab, measured by the occurrence of dose-limiting toxicities during the first cycle, and was assessed in all patients who had received at least one dose of evorpacept. Secondary outcomes included the safety, tolerability, and antitumour activity of evorpacept, alone or in combination with pembrolizumab or trastuzumab. The primary outcome, safety, and tolerability were assessed in all patients who had received at least one dose of evorpacept, and antitumour activity was assessed in those who recieved at least one dose of study treatment and underwent at least one post-baseline tumor assessment. This trial is registered with ClinicalTrials.gov, NCT03013218.

FINDINGS:

Between March 6, 2017, and Feb 21, 2019, 110 patients received single-agent evorpacept (n=28), evorpacept plus pembrolizumab (n=52), or evorpacept plus trastuzumab (n=30), and were included in the safety analysis. Median follow-up was 29·1 months (95% CI not calculable [NC]-NC) in the single-agent cohort, 27·0 months (25·1-28·8) in the evorpacept plus pembrolizumab cohort, and 32·7 months (27·0-32·7) in the evorpacept plus trastuzumab cohort. Two (7%) dose-limiting toxicities in the first cycle were reported in patients who received single-agent evorpacept; neutropenia with an associated infection in one patient with gastroesophageal junction cancer who received 3 mg/kg once per week, and thrombocytopenia with associated bleeding in one patient with pancreatic cancer who received 30 mg/kg once every other week. No maximum tolerated dose was reached; the maximum administered doses were 10 mg/kg once per week or 30 mg/kg once every other week. The 10 mg/kg once per week dose was used in the expansion cohorts in combination with pembrolizumab or trastuzumab. The most common grade 3 or worse treatment-related adverse events were thrombocytopenia with single-agent evorpacept (two [7%] patients) and evorpacept plus pembrolizumab (two [4%]), and thrombocytopenia (two [7%]) and neutropenia (two [7%]) with evorpacept plus trastuzumab. In patients who received single-agent evorpacept, four treatment-related serious adverse events were reported. Five serious treatment-related adverse events related to evorpacept plus pembrolizumab were reported, and one serious adverse event related to evorpacept plus trastuzumab was reported. In response-evaluable patients in the dose-escalation phase (n=15) receiving single-agent evorpacept once per week, four (27%) had a best overall response of stable disease (two received 0·3 mg/kg, one received 3 mg/kg, and one received 10 mg/kg); in the 11 patients who received single-agent evorpacept at the highest dose of 30 mg/kg once every other week, two (18%) had stable disease. In the dose-expansion cohort, overall responses were recorded in four (20·0%; 95% CI 5·7-43·7) of 20 patients with HNSCC who received evorpacept plus pembrolizumab, in one (5·0%; 0·1-24·9) of 20 patients with NSCLC who received evorpacept plus pembrolizumab, and in four (21·1%; 6·1-45·6) of 19 patients with gastric or gastroesophageal junction cancer who received evorpacept plus trastuzumab.

INTERPRETATION:

The safety findings support the use of evorpacept in combination with pembrolizumab or trastuzumab for patients with advanced solid tumours. Preliminary antitumour activity results support future investigation of evorpacept combined with pembrolizumab or trastuzumab in patients with HNSCC, gastric or gastroesophageal junction cancer, and NSCLC.

FUNDING:

ALX Oncology.

175

项与 Evorpacept 相关的新闻（医药）

2025-09-05

·药时代

CD47的一次罕见成功！

融资的机会来了！~ 多家知名VC公司寻找优质投资标的，感兴趣的管线包括：（1）针对实体瘤的创新性TCE、（2）新靶点/新核素的创新性核药、（3）Abeta双靶点等CNS创新药、（4）新靶点/新MOA的自免创新药。请有相关产品的biotech公司立即联系药时代BD团队（BD@drugtimes.cn）！正文共：3204字 0图预计阅读时间：13分钟在沉寂许久后，CD47领域终于迎来了又一笔BD交易。 2025年8月28日，浙江昂利康制药股份有限公司（以下简称“昂利康”）发布公告，宣布其与亚飞(上海)生物医药科技有限公司（以下简称“亚飞生物”）、上海亲合力生物医药科技股份有限公司（以下简称“亲合力”）签署《战略合作协议之授权许可协议》，将获得靶向CD47的IMD-1005药物分子在中国（包括中华人民共和国大陆地区、香港特别行政区、澳门特别行政区以及中国台湾地区）的研发、生产、商业化独家权益。根据协议，昂利康将分阶段向亚飞生物、亲合力合计支付1.5亿元人民币首付款，以及向亲合力支付最高不超过6.2亿元人民币的研发、销售里程碑付款。此外，在协议约定的销售分成期间，昂利康需向亲合力支付12.8%的销售分成。近一两年，CD47研发领域整体并不乐观，失败案例数量远多于成功案例。昂利康的此次交易无疑为这一领域注入了新的活力。为什么说CD47是块难啃的硬骨头 2009年，斯坦福大学医学院Irving Weissman 教授团队在 Cell 上发表了一篇题为“CD47 Is an Adverse Prognostic Factor and Therapeutic Antibody Target on Human Acute Myeloid Leukemia Stem Cells“的论文。论文提到，经研究发现CD47在许多肿瘤细胞表面大量上调，通过使用抗CD47抗体，可以破坏CD47的“别吃我”信号，发出信号并释放巨噬细胞来吞噬肿瘤，在相关血液肿瘤中具有显著治疗作用。在这篇论文结果的助推下，CD47受到业内广泛关注，并被业界寄予"下一个PD-1"的期望。但十几年来，药企在CD47领域的探索并不顺利，或者宣布失败，或者半路退出。吉利德 2024年6月，吉利德在2024年欧洲血液学协会（EHA）会议上公布了其CD47单抗Magrolimab的III期 ENHANCE 研究新数据。数据显示，与安慰剂组相比，Magrolimab与化疗（阿扎胞苷+维奈克拉）的联用方案的完全缓解率更低，且死亡风险增加20.3%。也就是说，用了这款药，不仅病情得不到好转，还会增加死亡风险。 Magrolimab为吉利德49亿美元收购Forty Seven所得。2020年，通过这场价值不菲的收购，吉利德踌躇满志地入局CD47 ，跻身CD47领域头部玩家。但近4年的探索显示，CD47确实是个难啃的硬骨头。早在此项结果公布于众前，吉利德就已停止了这款CD47单抗的大部分临床试验的招募/研究（包括实体瘤和血液瘤）。 ENHANCE研究的停止意味着吉利德将全面放弃Magrolimab的开发。当时，吉利德表示，停止Magrolimab的研究是由于对该药物在实体瘤和血液肿瘤中所有可用的安全性和有效性数据进行了全面审查后的决定。艾伯维 2020年9月，天境生物同艾伯维就天境自主研发的CD47单抗——lemzoparlimab在全球开发和商业化开展合作。根据协议条款，艾伯维将向天境生物支付1.8亿美元的首付款、2000万美元的近期里程碑付款及最高17.4亿美元的里程碑付款。据悉，这是当时中国Biotech有史以来最大的跨国对外授权战略合作。但就在合作达成2年后（2022年中），艾伯维接连宣布终止了lemzoparlimab的两项临床试验：1）lemzoparlimab与口服或静脉注射地塞米松制剂联用或不联用，治疗成人多发性骨髓瘤（MM）的研究；2）lemzoparlimab+阿扎胞苷+venetoclax 联合治疗骨髓增生异常综合征（MDS）/AML的 I 期临床试验。在此基础上，2023年9月，艾伯维宣布终止了其与天境生物的这项合作，归还lemzoparlimab所有权益。 Arch Oncology和ALX Oncology Arch Oncology由Pamela Manning于2006年创立，是实打实的CD47领域的先驱玩家。凭借其CD47管线AO-176的积极研发进展，Arch Oncology成功于2016年、2019年及2021年分别筹集了 8600万美元、5000万美元及1.05亿美元，一时风头无两。但就在完成其C轮融资十几个月后，Arch Oncology突然宣布终止其在研CD47管线的所有研发工作，并解散了公司大部分员工。随后，Arch Oncology的CEO Laurence Blumberg 跳槽至ALX Oncology（以下简称为“ALX”）——另一家聚焦CD47领域的公司。ALX的核心管线为evorpacept（也称为 ALX148），也是一款CD47抑制剂。 ALX的CD47项目也毫无意外的不顺利。2023年8月，ALX宣布将终止evorpacept的ASPEN-02和ASPEN-05研究，这两项研究分别用于评估evorpacept与化疗药物联合治疗MDS和AML的有效性。目前evorpacept的研究仍在继续，研究结果有喜有悲。2024年7月，ALX报告了其ASPEN-06 II 期研究的顶线数据，结果显示，evorpacept联合疗法的ORR为 40.3%，对照组仅为 26.6%，有效改善了HER2阳性胃癌患者的肿瘤反应。但在今年早些时候，ALX也曾报告了evorpacept联合K药治疗转移性或不可切除的复发性头颈癌中的两项研究失败。辉瑞 2021年，辉瑞和Trillium Therapeutics（以下简称为“Trillium”）联合宣布，双方已达成协议，辉瑞将以约22.6亿美元的价格收购Trillium，获得其阻断CD47-SIRPα信号通路的两款在研疗法——TTI-622和TTI-621。目前，辉瑞的这两款CD47项目均已暂停。 2025年6月底，辉瑞宣布，因患者招募困难，将终止maplirpacept (TTI-622）与化疗药物（来那度胺）联合用于复发或难治性弥漫性大B细胞淋巴瘤患者的II期研究。但辉瑞特别强调，终止该研究是由于“招募受阻，并非安全或疗效翻车”。此前，辉瑞已将另一项CD47项目——TTI-621从管线列表中删除。 CD47 还需更多成功案例本次，昂利康的这笔交易的主要分子是IMD-1005。据昂利康信息，该分子由亲合力自研，是一款具有创新性的全球首创肿瘤微环境激活型遮罩型抗体药物，其抗体部分为CD47单抗。昂利康明确指出，IMD - 1005（昂利康将其重新命名为ALK - N002）作为全球创新的肿瘤微环境激活型IgG1亚型靶向CD47的遮罩型抗体药物，有望为肿瘤患者带来全新的免疫治疗方案，为肿瘤治疗领域注入新的活力。临床前研究结果显示，注射用IMD-1005在SHP77（人小细胞肺癌）及Raji（淋巴瘤）CDX肿瘤模型中，均能呈剂量依赖性抑制肿瘤生长，药效突出；在临床前动物安全性评价实验中，IMD-1005的安全性优秀。安全性问题是目前CD47领域的重点关注方向，此前很多项目都是折在了药物的安全性问题上。这与CD47表达机制有关。前文提到，CD47在许多肿瘤细胞表面大量上调。此前，正是因为这种机制层面上展现出的适应症拓展潜力，才吸引了不少药企和投资公司来此掘金。但需要注意的是，CD47不仅在肿瘤细胞表面表达，同时还在人体红细胞高度表达。当一款CD47抗体进入人体后，将优先和外周血中的红细胞和白细胞等正常细胞结合，未与正常细胞结合的 CD47抗体才能最终获得与肿瘤细胞结合的权力，起到肿瘤杀伤作用。因此，在研的 CD47管线一般剂量都不低。但这种高剂量会导致一个问题，即会有大量的CD47抗体与红细胞结合，并进一步导致红细胞被裂解/吞噬，最终导致溶血、贫血等不良反应发生。因此，如何绕开CD47的高剂量血液毒性是一众CD47管线在开发中重点考量的问题。昂利康此次交易的重点——IMD-1005主要是通过技术手段优化抗体结构，从而提升安全性。该CD47抗体对 CD47 靶点的结合活性因偶联了遮罩而大大降低，在血液中高度稳定，从而避免了CD47抗体活性所导致的血液毒性。目前CD47领域仍有大量类似IMD-1005的项目试图突破困境，改变该领域的研发现状。据智慧芽数据库信息显示，眼下全球仍有两百余条CD47管线在研，覆盖单抗、双抗、ADC、CAR-T等多个药物类型。其中，进入III期临床阶段的仅3家，分别为宜明昂科的timdarpacept、康方生物的ligufalimab及EpicentRx的nibrozetone。国内方面，宜明昂科现在正在推进两项相关III期临床，分别为：1）timdarpacept与替雷利珠单抗联用治疗PD(L)-1单抗难治性经典型霍奇金淋巴瘤；2）timdarpacept联合阿扎胞苷治疗慢性粒-单核细胞白血病。（信息来源于第一财经文章）康方生物针对ligufalimab的布局则涉及实体瘤及血液瘤两方面。其中，一项血液瘤临床研究是在美国开展的针对骨髓增生异常综合征的II期临床研究，一项实体瘤的临床研究是 CD47单抗联合 PD-1/VEGF双抗药物依沃西，对比K药一线治疗PD-L1表达阳性复发/转移性头颈部鳞状细胞癌的头对头III期临床试验。此外，在ASCO2025上，ImmuneOncia Therapeutics公布了其新一代CD47抗体IMC-002联合仑伐替尼治疗晚期肝细胞癌（HCC）患者的1b期临床试验中期结果。在这项剂量扩展阶段研究，IMC-002展现出良好的安全性特征，未报告中性粒细胞减少症或血小板减少症病例。13例患者中有2例（15%）出现轻度贫血，96%的不良事件为1-2级，且主要发生在首个治疗周期。目前，这些CD47产品均进展良好。这也说明一个问题，即：虽已有不少失败案例在前，但该领域仍有不少成功案例正在陆续披露。不过，仍需注意的是，在0个管线成功获批上市的前提下，CD47赛道的低成功率将导致投资者对该领域保持谨慎态度。一笔交易带给整个赛道的活力是有限的，无论交易还临床数据，CD47赛道仍在等待更多成功案例！接下来是一条会议宣传：目前，药时代与肝病新药联盟应行业需求，决定于2025年11月21-22日在上海举办“第四届肝病新药联盟年会暨减重新药论坛”活动（线下）。活动有幸邀请到了多位行业资深专家，将聚焦肝病及相关领域的最新科研成果、临床实践和未来发展方向，来自医院、药企、CRO、投资机构等单位的专家、学者们将齐聚一堂，从不同的角度分享他们的行业洞见和宝贵经验。欢迎感兴趣的读者持续关注，药时代公众号将持续更新会议最新动态。主办单位：肝病新药联盟、药时代协办单位：中国医药生物技术协会慢病管理分会、中国医师协会脂肪肝专家委员会、爱肝联盟。展位火热预定中！扫码立即咨询赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。参考资料： 1.https://www.biospace.com/embattled-researchers-see-path-forward-for-anti-cd47-cancer-drugs 2.https://endpoints.news/scoop-roche-backed-startup-gives-up-on-cd47-as-ceo-most-employees-leave/ 3.https://endpoints.news/scoop-roche-backed-startup-gives-up-on-cd47-as-ceo-most-employees-leave/ 4.其他公开资料图片来源：即梦AI 刚刚！超10亿美元！恒瑞医药宣布Myosin抑制剂NewCo出海 2025-09-05 FDA推出新加速审评通道！直指超罕见遗传病 2025-09-04 这家Biotech融资2亿美元！曾与恒瑞达成合作... 2025-09-04 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看往期肝病新药联盟精彩活动！

引进/卖出临床3期并购

2025-08-20

·PipelineReview

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

– A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN FRANCISCO, CA, USA I August 19, 2025 I ALX Oncology Holdings Inc., (“ALX Oncology” or the”Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. “Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026.” The Phase 1 clinical trial ( NCT07085091 ) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. ALX2004: Optimized for Success Based on Rigorous Drug Design Process Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ ALX Oncology . SOURCE: ALX Oncology

临床1期抗体药物偶联物免疫疗法

2025-08-19

·ir.alxoncology.com

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN FRANCISCO, Calif., Aug. 19, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the"Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. "Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026." The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. ALX2004: Optimized for Success Based on Rigorous Drug Design Process Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown Healthcare Communications audrafriis@sambrown.com (917) 519-9577

临床1期抗体药物偶联物

100 项与 Evorpacept 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12193	-	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HER2表达胃腺癌	临床3期	美国	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	美国	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	日本	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	日本	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	澳大利亚	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	比利时	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	比利时	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	ALX Oncology, Inc.	2022-01-15

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05025800 (AACR2025) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept + lenalidomide + rituximab	構構鏇糧夢齋糧繭憲繭(遞遞蓋積鹹簾膚獵鹹鏇) = 遞醖範淵鹽製鹹鏇獵選壓顧憲衊蓋鏇淵襯製餘 (網鑰範廠襯構夢壓顧窪 ) 更多	积极	2025-04-29
NCT04675294 (ASPEN-03, Company_Website) 人工标引	临床2期	晚期头颈部鳞状细胞癌一线 PD-L1 Positive	-	Evorpacept + pembrolizumab	襯觸鏇夢窪餘廠製齋餘(獵鹽鹽構積齋憲築夢顧) = Not Meet Primary Endpoints 繭繭衊網遞廠製蓋憲繭 (範鹹憲製夢鹹餘遞夢觸 ) 未达到	不佳	2025-04-25
				pembrolizumab
NCT04675333 (ASPEN-04, Company_Website) 人工标引	临床2期	晚期头颈部鳞状细胞癌	-	evorpacept + pembrolizumab + chemotherapy	壓糧壓範窪構憲製憲艱(糧窪網鏇鑰壓顧艱齋構) = Not Meet Primary Endpoints. 壓範鏇艱築範廠襯遞網 (網製簾齋壓顧鹽窪醖襯 ) 未达到	不佳	2025-04-25
				pembrolizumab + chemotherapy
NCT05002127 (ASPEN-06, Corporate Publications) 人工标引	临床2/3期	HER2阳性胃食管交界处癌 \| HER2阳性胃癌 HER2 Positive	127	Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel	夢獵鏇鬱繭鹽選窪獵餘(鏇艱範選窪網廠積範製) = 襯範範糧壓淵齋範鹽範憲壓壓鏇簾齋壓獵遞築 (積襯壓願衊廠襯積憲鹹, 29.0 ~ 54.4) 更多	积极	2025-01-23
				Trastuzumab + Ramucirumab + Paclitaxel	夢獵鏇鬱繭鹽選窪獵餘(鏇艱範選窪網廠積範製) = 壓襯鹽鹹願鬱鏇窪鑰膚憲壓壓鏇簾齋壓獵遞築 (積襯壓願衊廠襯積憲鹹, 16.3 ~ 39.1) 更多
NCT05002127 (ASPEN-06, ASCO_GI2025) 人工标引	临床2/3期	HER2阳性胃食管腺癌 \| HER2阳性胃癌 HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鏇願憲鬱窪醖獵糧製鬱(淵簾鑰範顧壓醖鏇淵廠) = 窪鹹蓋繭廠鹽選積鹹簾選襯廠窪繭顧鹽糧衊壓 (願選鹹觸糧壓選鏇鹹廠 ) 更多	积极	2025-01-23
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鏇願憲鬱窪醖獵糧製鬱(淵簾鑰範顧壓醖鏇淵廠) = 鏇簾築齋簾遞襯獵鑰網選襯廠窪繭顧鹽糧衊壓 (願選鹹觸糧壓選鏇鹹廠 ) 更多
NCT05002127 (ASPEN-06, Company_Website) 人工标引	临床2/3期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌 HER2 Positive	127	Evorpacept + trastuzumab + CYRAMZA + paclitaxel	簾鏇鏇簾艱鏇鑰鏇衊夢(淵淵築鹹餘蓋艱夢網壓) = 鹹選鏇鏇鏇壓鏇製憲顧夢網觸積壓網壓淵糧艱 (膚繭廠衊鬱鬱積襯鏇糧 ) 更多	积极	2024-07-31
				Trastuzumab + CYRAMZA + paclitaxel	簾鏇鏇簾艱鏇鑰鏇衊夢(淵淵築鹹餘蓋艱夢網壓) = 範鏇顧鬱構願鹹網範鹽夢網觸積壓網壓淵糧艱 (膚繭廠衊鬱鬱積襯鏇糧 ) 更多
NCT05524545 (ASCO2024) 人工标引	临床1期	局部晚期尿路上皮癌 \| 转移性尿路上皮癌	20	Evorpacept 20 mg/kgenfortumab vedotin	願繭鹹壓觸繭繭糧顧廠(艱鹹顧鑰範醖積觸蓋選) = Not observed. 簾觸衊製簾蓋淵積襯夢 (醖鬱製鹽願蓋醖製鬱廠 ) 更多	积极	2024-05-24
NCT05167409 (ASCO2024) 人工标引	临床2期	转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	16	Evorpacept (E) 15 mg/kgcetuximabpembrolizumab	醖窪繭糧鏇遞醖艱淵選(鹹積鏇夢壓夢糧獵襯糧) = 積衊淵構窪衊觸淵醖選顧廠醖鬱憲獵範鬱網壓 (壓顧窪繭憲鏇構窪醖衊 ) 更多	不佳	2024-05-24
NCT05025800 (AACR2024) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept+rituximab+lenalidomide	窪蓋選餘醖繭遞鏇範製(糧簾艱鏇廠簾觸淵鬱餘) = 醖醖積窪襯願遞鏇範鬱獵淵獵築膚餘願窪鹹構 (積簾艱鏇構夢積遞襯選 ) 更多	积极	2024-04-05
NCT05002127 (ASPEN-06, NEWS) 人工标引	临床2期	转移性 HER2 阳性胃食管结合部癌 \| HER2阳性胃癌二线 HER2 Positive	54	Evorpacept 30 mg/kg+trastuzumab + CYRAMZA + paclitaxel	襯蓋憲齋築製糧醖觸鏇(獵衊壓餘窪鬱積蓋繭壓) = 願蓋憲築齋範網鏇壓構願願鬱衊襯壓遞網鑰壓 (夢餘獵醖窪鹽積艱齋選 ) 更多	积极	2023-10-03
				trastuzumab + CYRAMZA + paclitaxel	襯蓋憲齋築製糧醖觸鏇(獵衊壓餘窪鬱積蓋繭壓) = 鹽簾構築築顧鹹網餘糧願願鬱衊襯壓遞網鑰壓 (夢餘獵醖窪鹽積艱齋選 ) 更多