This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial receptor-1 (CLEVER-1). Treating with an antiCLEVER-1 antibody, such as bexmarilimab, could lead to immune system activation, which, in turn, may lead to cancer elimination.

开始日期2023-06-01

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

NCT05428969

/ Active, not recruiting临床1/2期

A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination With Standard of Care Therapy in Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia

This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1.

开始日期2022-06-02

申办/合作机构

Faron Pharmaceuticals Oy

NCT05104905

/ Withdrawn临床1/2期

A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma (Macrophage Antibody To Inhibit Immune Suppression in RENAl Cell and COLon Carcinomas)

Bexmarilimab treatment has demonstrated tolerable safety profile and anticancer efficacy in some subjects with advanced malignancies. This is the first study to investigate the effect of single neoadjuvant dose of anti-CLEVER-1 antibody bexmarilimab prior to radical surgery of renal cell and colon cancers. We expect that the single dose will demonstrate measurable effects on the tumour immunological microenvironment as well as systemic effects on subject´s immunological status and that this evidence may be used to guide future neoadjuvant studies. There will be a dose escalation to investigate the effect of different doses of bexmarilimab. In addition to subjects receiving single neoadjuvant dose of bexmarilimab, there will be an observational cohort without Investigational Medicinal Product (IMP) for either cancer. All patients participating in the study (whether in investigational or observational cohort) will attend each visit and are assessed for the same endpoints.

开始日期2021-10-07

申办/合作机构

Faron Pharmaceuticals Oy

100 项与贝马瑞利单抗相关的临床结果

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100 项与贝马瑞利单抗相关的转化医学

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项与贝马瑞利单抗相关的文献（医药）

2025-11-01·Journal for ImmunoTherapy of Cancer

Correction: Macrophage sensitivity to bexmarilimab-induced reprogramming is shaped by the tumor microenvironment

Article

2025-07-01·Lancet Haematology

Bexmarilimab plus azacitidine for high-risk myelodysplastic syndrome and relapsed or refractory acute myeloid leukaemia: results from the dose-escalation part of a multicentre, single-arm, phase 1/2 trial

Article

作者: Ylitalo, Arno ; Rimpiläinen, Johanna ; Stein, Anthony Selwyn ; Daver, Naval ; Fjällskog, Marie-Louise ; Aakko, Sofia ; Kontro, Mika ; Pyörälä, Marja ; Hollmén, Maija ; Jalkanen, Juho ; Pawlitzky, Inka ; Siitonen, Timo

BACKGROUND:

Bexmarilimab blocks Clever-1 on macrophages to enhance antigen presentation and T cell activation. Because Clever-1 is expressed by myeloid leukaemia cells, bexmarilimab may combat leukaemia and influence the tumour microenvironment to augment the effectiveness of standard-of-care therapy in patients with myelodysplastic syndrome and acute myeloid leukaemia. The aim of this study was to determine the safety of bexmarilimab in combination with standard-of-care treatment in myelodysplastic syndrome and acute myeloid leukaemia and to identify the recommended dose for expansion of bexmarilimab in combination with standard of care.

METHODS:

The phase 1 dose-escalation part of this multicentre, single-arm, phase 1/2 study was done at six centres in Finland and the USA. Patients aged 18 years or older (Eastern Cooperative Oncology Group performance status of 2 or less) with myelodysplastic syndrome (2016 WHO) with a Revised International Prognostic Scoring System (IPPS-R) score of 3·5 or more for USA (3·0 for the European Union), chronic myelomonocytic leukaemia (2016 WHO) with 10-19% marrow blasts, myelodysplastic syndrome or chronic myelomonocytic leukaemia with no response to or disease progression during hypomethylating agent treatment, or relapsed or refractory acute myeloid leukaemia were treated with escalating doses of bexmarilimab (1·0 mg/kg, 3·0 mg/kg, and 6·0 mg/kg, intravenous, once weekly, 28-day cycle) in combination with azacitidine, administered as per label. Here we report the phase 1 part of the study, for which the primary outcome was safety (the incidence and frequency of dose limiting toxicities and the frequency and severity of adverse events) as well as the determination of the maximum tolerated dose and recommended expansion dose for the phase 2 part using a Bayesian optimal interval design. All patients receiving at least one dose of bexmarilimab were included in safety analyses, and those with a post-baseline activity assessment were included in activity analyses. This trial is registered with ClinicalTrials.gov (NCT05428969) and EudraCT (2021-002104-12) databases. Phase 2 of the study is ongoing in patients with myelodysplastic syndrome with no response to hypomethylating agent.

FINDINGS:

Between June 2, 2022, and Dec 7, 2023, 33 patients (14 with myelodysplastic syndrome, 19 with relapsed or refractory acute myeloid leukaemia) were enrolled in phase 1; no patients with chronic myelomonocytic leukaemia were identified. 19 (58%) patients were male and 14 (42%) were female, and 24 (73%) patients were non-Hispanic ethnicity, and eight (24%) were White. Median follow-up time for all patients was 6·2 months (IQR 3·5-10·7). The maximum tolerated dose was not reached, and the recommended expansion dose for phase 2 was established as 6·0 mg/kg in patients with myelodysplastic syndrome with no response to hypomethylating agents. There were no dose-limiting toxicities. The most common grade 3-4 treatment-emergent adverse events were febrile neutropenia (n=8 [24%]), anemia (n=7 [21%]), and thrombocytopenia (n=5 [15%]). Treatment-emergent deaths occurred as a result of sepsis (n=1 [3%]), neutropenic infection (n=1 [3%]), and haemophagocytic lymphohistiocytosis (n=1 [3%]). Four patients presented treatment-related serious adverse events, one patient in the 1·0 mg/kg group, two in the 3·0 mg/kg group and one in the 6·0 mg/kg group. These included rash (grade 3), capillary leak syndrome (grade 3), cryptogenic organising pneumonia (grade 3) and haemophagocytic lymphohistiocytosis (grade 5) which led to one death. The objective response rate was 45% (15 of 33; 95% CI 28-62) across all doses.

INTERPRETATION:

Bexmarilimab in combination with azacitidine has a manageable safety profile, consistent with azacitidine, and shows promising clinical activity in patients with high-risk myelodysplastic syndrome.

FUNDING:

Faron Pharmaceuticals.

2025-06-23·Theranostics

Secreted Clever-1 modulates T cell responses and impacts cancer immunotherapy efficacy

Article

作者: Shetty, Shishir ; Turpin, Rita ; di Benedetto, Ilaria ; Bendes, Ábris Á ; Figueiredo, Carlos R ; Ylitalo, Arno ; Sjöroos, Riikka ; Salminen, Tiina A ; Rannikko, Jenna H ; Patten, Daniel A ; Viitala, Miro ; Hollmén, Maija ; Boström, Pia ; Prince, Stuart ; Koskivuo, Ilkka ; Tyni, Laura

Rationale: Clever-1 is a multifunctional scavenger receptor that promotes immunosuppressive activity in macrophages, contributing to tumor immune evasion. Its high expression correlates with resistance to immune checkpoint inhibitors, and co-targeting Clever-1 with anti-PD-1 enhances therapeutic efficacy in refractory tumor models. The humanized anti-Clever-1 IgG4 antibody, bexmarilimab, is under clinical investigation for treating solid tumors (NCT03733990) and hematological malignancies (NCT05428969). Methods: To assess the impact of Clever-1 in cancer, we analyzed plasma samples from breast cancer patients (n=139) and bexmarilimab-treated clinical trial participants (n=193) using TRFIA-based ELISA to quantify secreted Clever-1 (sClever-1). A recombinant sClever-1 protein was produced and characterized biophysically. Functional assays, including flow cytometry, Western blotting, T cell activation, and Jurkat reporter systems, were used to assess interactions with T cells. Mechanistic studies involved extracellular vesicle isolation, pulldown assays, and mass spectrometry. Inhibitor studies and patient-derived tumor explants were used to evaluate the immunomodulatory impact of sClever-1 and its effect on anti-PD-1 responses. Results: sClever-1 was significantly enriched in the plasma of cancer patients and reduced following bexmarilimab treatment. Its release was induced by IFNγ/LPS via serine protease-dependent cleavage. The recombinant sClever-1 bound selectively to activated T cells via mannose-6-phosphate-mediated interaction with IGF2R, impairing TCR signaling and Th1 expansion. sClever-1 was also associated with macrophage-derived extracellular vesicles and contributed to T cell tolerance and reduced anti-PD-1 efficacy. In tumor explants, sClever-1 bound to activated CD4⁺ and CD8⁺ T cells and increased TGFβ secretion. Conclusions: These findings identify sClever-1 as a previously unrecognized, immunosuppressive mediator in cancer that operates independently of cellular Clever-1 expression. sClever-1 may serve as both a therapeutic target and biomarker to guide immunotherapy strategies.

项与贝马瑞利单抗相关的新闻（医药）

2025-10-13

·ioncology

ESMO 瞭望前瞻丨血液肿瘤领域十大高关注度研究榜单揭晓

2025年欧洲肿瘤内科学会年会 ESMO 2025 2025年欧洲肿瘤内科学会（ESMO）大会即将于10月17日至21日在德国柏林隆重举行，肿瘤学领域迎来新一轮科研盛放。其中，血液学领域研究涵盖了多个令人瞩目的前沿方向：从深入探究CAR - T耐药机制的奥秘，为攻克这一治疗难题寻找新的突破口；到双靶点疗法的创新探索，有望为患者带来更精准、更有效的治疗方案；再到多发性骨髓瘤精准停药研究，为患者实现长期生存与生活质量提升带来新的希望；以及单细胞图谱的绘制，为深入理解血液疾病的发病机制提供了全新的视角。这些研究无一不彰显着医学科技的不断进步与创新，也为血液疾病的诊疗带来了新的曙光。为了更好地聚焦血液领域的重大突破、推动学术交流与思想碰撞，《肿瘤瞭望-血液时讯》特别发起ESMO专项栏目，并广泛征集读者关注的研究议题。以下为根据投票结果整理出的十大高关注度研究，排序反映临床与科研同仁的最新兴趣方向。本刊后续将结合投票情况，对重点研究进行持续追踪，并邀请国内血液领域权威专家进行专业解读，从研究设计、结果意义到未来临床影响等多维度展开深入探讨，为临床实践与学术创新提供参考。值得关注的是，ESMO 2025大会常规摘要（包括口头报告与壁报）定于中欧夏令时间2025年10月13日00:05在官网发布；最新突破摘要（LBA）则将于研究公布当日00:05上线。十大高关注度研究（按票数排序） 1248MO 急性髓系白血病含维奈克拉方案治疗前后，外周血白血病干细胞、免疫细胞亚群、细胞因子及细胞分化状态的变化 1240O CD19/CD22双特异性CAR-T细胞治疗复发/难治性大B细胞淋巴瘤：一项前瞻性、单臂、单中心、II期临床试验 1241O 抗PD-1抗体（替雷利珠单抗）联合西达本胺、来那度胺和依托泊苷治疗难治性/复发性鼻型结外自然杀伤/T细胞淋巴瘤：一项前瞻性、多中心、单臂、II期试验的初步结果 1242O 多发性骨髓瘤患者自体干细胞移植后，持续的骨髓和影像学 MRD 阴性可导致来那度胺停药：一项前瞻性队列研究的最新结果 1243MO 整合中期18F-FDG PET-CT分析和NCCN-IPI对弥漫性大B细胞淋巴瘤进行风险分层：一项多中心回顾性研究 1246MO 单细胞循环免疫图谱揭示了可预测对R-CHOP和抗CD19 CAR-T疗法应答的共同特异性DLBCL特征 LBA47 高级别B细胞淋巴瘤中的CAR-T细胞耐药性由肿瘤相关巨噬细胞所决定 1249MO 巨噬细胞重编程剂 Bexmarilimab 联合阿扎胞苷治疗骨髓增生异常综合征：1/2 期 BEXMAB 研究的 PK/PD 和生物标志物结果 1247MO 不同滤泡性淋巴瘤组织学分级的分子图谱：来自基因组和转录组分析的见解 1244MO 对新诊断的多发性骨髓瘤患者进行全身序贯磁共振成像疗效评估（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

免疫疗法细胞疗法临床2期ASH会议IPO

2025-10-11

·ioncology

ESMO瞭望前瞻丨血液肿瘤领域重磅研究一文全览

2025年欧洲肿瘤内科学会年会 ESMO 2025 2025年欧洲肿瘤内科学会（ESMO）年会即将于10月17日至21日在德国柏林隆重举行，肿瘤学领域将迎来新一轮科研盛放。其中，血液学领域研究涵盖了多个令人瞩目的前沿方向：从深入探究CAR-T耐药机制的奥秘，为攻克这一治疗难题寻找新的突破口；到双靶点疗法的创新探索，有望为患者带来更精准、更有效的治疗方案；再到多发性骨髓瘤精准停药研究，为患者实现长期生存与生活质量提升带来新的希望；以及单细胞图谱的绘制，为深入理解血液疾病的发病机制提供了全新的视角。这些研究无一不彰显着医学科技的不断进步与创新，也为血液疾病的诊疗带来了新的曙光。为助力广大读者与参会者提前了解相关内容，《肿瘤瞭望-血液时讯》特别梳理血液领域重磅研究，以供参考。专题口头报告环节：血液系统恶性肿瘤（2025年10月17日，星期五，当地时间） 1240O：CD19/CD22双特异性CAR-T细胞疗法治疗复发/难治性大B细胞淋巴瘤：一项前瞻性、单臂、单中心II期临床试验该前瞻性、单臂、单中心II期研究（NCT06081478）评估了一种新型CD19/CD22双靶点CAR-T细胞疗法在14-85岁复发/难治性B细胞淋巴瘤或B细胞急性淋巴细胞白血病患者中的疗效。所有入组患者均接受标准一线治疗后复发/难治，且CD19/CD22表达阳性。治疗方案为单次输注，剂量为2.0×10⁶ CD19阳性细胞/kg和1.0×10⁶ CD22阳性细胞/kg。主要研究终点为总缓解率（ORR）。 2025年欧洲血液学协会（EHA）大会公布的II期研究数据显示，该双特异性CAR-T疗法在复发/难治性大B细胞淋巴瘤患者中表现出良好的安全性与疗效。 1241O：抗PD-1抗体（替雷利珠单抗）联合西达本胺、来那度胺和依托泊苷治疗复发/难治性鼻型结外自然杀伤/T细胞淋巴瘤（r/r-ENKTL）：一项前瞻性、多中心、单臂II期试验的初步结果本前瞻性、开放标签、单臂、多中心II期试验（NCT04038411）在中国开展，评估替雷利珠单抗联合西达本胺、来那度胺（Revlimid）和依托泊苷在14-65岁、经至少2线治疗失败的复发/难治性自然杀伤/T细胞淋巴瘤患者中的疗效。入组标准包括ECOG体能状态评分0-2分、预期生存期≥3个月及至少1个可测量病灶。治疗方案为：替雷利珠单抗240 mg（第1天），西达本胺20 mg（每周2次），来那度胺25 mg/天（第1-14天），依托泊苷100 mg/m²（第1-3天），每21天为一个周期。主要研究终点为ORR。 1242O：多发性骨髓瘤患者自体干细胞移植后持续骨髓及影像学微小残留病灶（MRD）阴性可指导来那度胺停药：一项前瞻性队列研究的更新结果小型口头报告环节：血液系统恶性肿瘤（2025年10月19日，星期日，当地时间） 1243MO：基于中期¹⁸F-FDG PET-CT分析与NCCN-IPI的弥漫大B细胞淋巴瘤风险分层：一项多中心回顾性研究本回顾性研究在中国开展，纳入498例弥漫大B细胞淋巴瘤（DLBCL）患者，分析其临床病理与PET-CT数据，评估中期国家综合癌症网络国际预后指数（NCCN-IPI）与PET-CT相关参数的预后价值，以优化风险分层与预后预测。 1245MO：米托蒽醌脂质体联合西达本胺治疗复发/难治性外周T细胞淋巴瘤：II期研究的更新结果本报告将公布I/II期试验（NCT05527275）II期部分的更新结果，评估米托蒽醌脂质体联合西达本胺在复发/难治性外周T细胞淋巴瘤患者中的疗效。前期数据显示，该联合方案在此类患者中表现出良好的疗效与可控的安全性。研究纳入18-75岁、经病理确诊的非特指型外周T细胞淋巴瘤、血管免疫母细胞性T细胞淋巴瘤、间变性大细胞淋巴瘤及其他亚型患者。入组标准包括复发/难治性疾病、可测量病灶及ECOG体能状态评分0-2分。I期剂量递增阶段后，II期阶段患者接受推荐剂量治疗，主要研究终点为ORR。 1249MO：巨噬细胞重编程药物Bexmarilimab联合阿扎胞苷治疗骨髓增生异常综合征：I/II期BEXMAB研究的药代动力学/药效动力学及生物标志物结果 I/II期BEXMAB试验（NCT05428969）评估Bexmarilimab联合阿扎胞苷在较高危骨髓增生异常综合征（MDS）患者中的疗效。2025年美国临床肿瘤学会（ASCO）年会公布的数据显示，未报告与Bexmarilimab相关的5级不良反应，复发/难治性患者的中位总生存期为13.4个月，初治与复发/难治性患者的ORR分别为72%和63%。其他报告 1246MO - 循环免疫单细胞图谱揭示预测R-CHOP与抗CD19 CAR-T疗法响应的弥漫大B细胞淋巴瘤共同特征 1247MO - 不同滤泡性淋巴瘤组织学分级的分子图谱：基因组与转录组分析的启示 1248MO - 维奈克拉方案治疗急性髓系白血病前后外周血白血病干细胞、免疫细胞亚群、细胞因子及细胞分化状态的动态变化 1250MO - 接受二线治疗的慢性髓系白血病患者预后分析（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

细胞疗法临床2期免疫疗法ASH会议

2025-06-07

·药明康德

客观缓解率达100%的抗体疗法；100%降解目标蛋白的潜在“first-in-class”口服降解剂…… | 一周盘点

本期看点1. 靶向Clever-1的单克隆抗体bexmarilimab与标准治疗（SoC）联用治疗初治高危骨髓增生异常综合征（HR-MDS）患者的早期临床试验结果亮眼，客观缓解率（ORR）达100%。2. 口服靶向抗癌化合物ibrilatazar联合化疗治疗III/IV期鳞状非小细胞肺癌（SQ-NSCLC）患者的1/2a期临床试验结果积极，与历史对照相比，联合治疗组的中位总生存期（OS）接近翻倍（22.5个月对比11.3个月）。3. Kymera Therapeutics公司的口服STAT6降解剂KT-621在一项1期研究的所有≥50 mg的多剂量递增（MAD）组中表现积极，患者血液与皮肤中的目标蛋白均达成完全降解。Bexmarilimab：公布1期联合治疗试验数据Faron Pharmaceuticals公司宣布，其靶向Clever-1的单克隆抗体bexmarilimab的一项1期研究结果已发表在《柳叶刀-血液学》（Lancet Haematology）杂志上。该研究旨在评估bexmarilimab联合SoC治疗高危骨髓增生异常综合征和复发/难治性（r/r）急性髓系白血病（AML）患者的安全性和有效性。Bexmarilimab是Faron公司全资拥有的研究性免疫疗法，旨在通过靶向髓系细胞功能和激活免疫系统，克服对现有疗法的耐药性并优化临床疗效。Bexmarilimab能与巨噬细胞上的免疫抑制受体Clever-1结合，该受体有助于肿瘤生长和转移（即帮助癌症躲避免疫系统）。通过靶向巨噬细胞上的Clever-1受体，bexmarilimab可改变肿瘤微环境，将巨噬细胞从免疫抑制（M2）状态重编程为免疫刺激（M1）状态，上调干扰素的产生，启动免疫系统攻击肿瘤，使癌细胞对标准治疗敏感。此次公布的结果显示，bexmarilimab联合阿扎胞苷在初治和低甲基化药物（HMA）治疗失败的HR-MDS患者中的ORR分别为100%和89%。HMA治疗失败的MDS患者的估计中位OS为13.4个月，r/r AML患者为8.1个月。两名HMA治疗失败的MDS患者在治疗后接受了造血干细胞移植（HSCT）。此外，治疗后患者的骨髓免疫生物标志物较基线水平提升了近3倍。在67%的HMA治疗失败的MDS患者中观察到HLA-DR分子增加，进一步支持bexmarilimab的作用机制。安全性方面，bexmarilimab联合治疗的耐受性良好，未观察到剂量限制性毒性。大多数治疗伴发不良事件（TEAE）为轻度至中度，仅6%与bexmarilimab相关。Ibrilatazar（ABTL0812）：公布1/2a期联合治疗试验数据AbilityPharma公司宣布，其评估ibrilatazar（ABTL0812）联合化疗（紫杉醇/卡铂）治疗III/IV期鳞状非小细胞肺癌患者的1/2a期临床试验ENDOLUNG的数据已发表在Lung Cancer杂志上。Ibrilatazar是一种潜在“first-in-class”、差异化的口服靶向抗癌化合物，通过诱导内质网应激和抑制PI3K/Akt/mTOR通路来引发自噬。在临床试验中，ibrilatazar对子宫内膜癌和肺癌患者显示出临床益处。此外，它在包括肺癌、子宫内膜癌、胰腺癌、神经母细胞瘤和胶质母细胞瘤等癌症类型的动物模型中展示了强有力的临床前概念验证。此次公布的结果显示，与历史对照相比，ibrilatazar联合化疗在所有疗效终点均显示出改善，包括：ibrilatazar联合治疗组的总缓解率为52%，历史对照为31.7%；ibrilatazar联合治疗组的中位无进展生存期（PFS）为6.2个月，历史对照为4.2个月；ibrilatazar联合治疗组的中位OS为22.5个月，历史对照为11.3个月。安全性方面，ibrilatazar联合化疗表现出良好的安全性。在紫杉醇/卡铂基础上加入ibrilatazar的安全性与历史对照中紫杉醇/卡铂单独使用时的安全性一致，并未带来除紫杉醇/卡铂本身已知不良事件之外的显著新增安全性风险。KT-621：公布1期临床试验数据Kymera Therapeutics公司公布其潜在“first-in-class”口服STAT6降解剂KT-621在1期健康受试者研究中的积极结果。数据显示，KT-621在每日一次口服给药下，于所有高于1.5 mg剂量水平中实现了超过90%的平均血液STAT6降解；在所有≥50 mg的MAD组中，更在血液与皮肤中均达成完全降解。此外，KT-621对Th2炎症相关生物标志物TARC和Eotaxin-3的中位降低幅度分别高达37%与63%，表现优于或相当于现有获批药物。KT-621在本项试验中展现出优异的安全性，未观察到严重不良事件或与治疗相关的不良事件，整体耐受性与安慰剂无明显差异。Kymera公司指出，KT-621的临床表现已显著优于其预设的产品特征目标，进一步验证了其“生物制品口服化”开发策略的可行性。当前，KT-621正在中重度特应性皮炎（AD）患者中开展1b期BroADen试验，预计将在2025年第四季度公布数据，并计划分别于2025年第四季度与2026年第一季度启动针对AD与哮喘的两项2b期临床研究。ISB 2001：公布1期临床试验的新数据Ichnos Glenmark Innovation公司公布了其三特异性抗体ISB 2001用于治疗复发/难治性多发性骨髓瘤（RRMM）的1期研究的新数据。ISB 2001同时靶向多发性骨髓瘤（MM）细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。此次公布的结果显示，在经过大量治疗的患者群体中，7个活性剂量（≥50 μg/kg）组患者的持续总缓解率为79%，完全缓解/严格完全缓解（CR/sCR）率为30%。所有接受治疗的患者的总缓解率为74%，包括2例接受较低剂量治疗的患者。安全性方面，ISB 2001具有良好的安全性，大多数患者在数据截止时仍在接受治疗。EBC-129：公布1期临床试验的新数据新加坡实验药物研发中心（EDDC）公布了其在研抗体偶联药物（ADC）EBC-129的一项1期临床试验的新数据。EBC-129靶向CEACAM5和CEACAM6上保守的肿瘤特异性N256糖基化位点，这两种蛋白在肿瘤发生和转移中起关键作用。该ADC的毒性有效载荷是微管蛋白抑制剂MMAE，该药物已在其他上市的ADC中被广泛测试并获批用于临床，且已显示出与PD-1抑制剂之间的协同作用。此次公布的结果显示，EBC-129在21名此前接受过大量治疗的胰腺导管腺癌（PDAC）患者中显示出积极的总缓解率和延长的无进展生存期，包括那些之前接受过SoC（通常含有紫杉烷类药物）的患者。在接受1.8 mg/kg和2.2 mg/kg剂量治疗的患者中，总缓解率分别为25%和20%，疾病控制率（DCR）达87.5%和63.6%，中位PFS分别为19周和12周。EBC-129在迄今为止接受治疗的58例患者中显示出可控的安全性，观察到的主要治疗相关不良事件（TRAE）为无并发症的中性粒细胞减少和输液相关反应。IMC-002：公布1期联合治疗试验的中期数据ImmuneOncia Therapeutics公司公布了其下一代CD47靶向抗体IMC-002与lenvatinib联用治疗晚期肝细胞癌（HCC）患者的1b期临床试验的中期结果。IMC-002是一款全人源化IgG4单克隆抗体，通过阻断CD47-SIRPα相互作用，促进巨噬细胞对肿瘤细胞的吞噬作用。该抗体疗法可以在保证高疗效的同时最大限度地减少与红细胞的结合并避免血液学毒性。此次公布的结果显示，IMC-002表现出良好的安全性特征，未报告中性粒细胞减少或血小板减少，96%的不良事件为1/2级。在疗效可评估的10名患者中，有3名达到部分缓解（PR），DCR达80%，中位PFS为8.3个月。两名患者的治疗时间已超过一年，提示该疗法可能带来持久的临床获益。参考资料（可上下滑动查看）[1] ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/immuneoncia-announces-interim-results-from-phase-1b-clinical-trial-of-next-generation-cd47-antibody-imc-002-at-asco-2025-302470514.html[2] Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/122/pasithea-therapeutics-presents-updated-interim-data-from[3] Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/01/3091475/0/en/Allogene-Therapeutics-Provides-Updated-Phase-1-Data-Highlighting-Durable-Responses-with-ALLO-316-in-Heavily-Pretreated-Advanced-Renal-Cell-Carcinoma-at-ASCO.html[4] MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study. Retrieved June 5, 2025, from https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8613[5] NervGen Pharma Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091725/0/en/NervGen-Pharma-Reports-Positive-Topline-Data-from-the-Chronic-Cohort-of-its-Phase-1b-2a-Clinical-Trial-Evaluating-NVG-291-in-Spinal-Cord-Injury.html[6] Kymera Therapeutics Announces Positive First-in-Human Results from Phase 1 Healthy Volunteer Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091701/0/en/Kymera-Therapeutics-Announces-Positive-First-in-Human-Results-from-Phase-1-Healthy-Volunteer-Clinical-Trial-of-KT-621-a-First-in-Class-Oral-STAT6-Degrader.html[7] Erasca Announces IND Clearance for Potential First-in-Class and Best-in-Class Pan-KRAS Inhibitor ERAS-4001. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091800/0/en/Erasca-Announces-IND-Clearance-for-Potential-First-in-Class-and-Best-in-Class-Pan-KRAS-Inhibitor-ERAS-4001.html[8] Diakonos Oncology Presents Promising Phase I Results of Dubodencel (DOC1021) for the Treatment of Glioblastoma at the ASCO 2025 Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/diakonos-oncology-presents-promising-phase-i-results-of-dubodencel-doc1021-for-the-treatment-of-glioblastoma-at-the-asco-2025-annual-meeting-302469896.html[9] GV20 Therapeutics Presents Updated Phase 1 Monotherapy Data on GV20-0251 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/gv20-therapeutics-presents-updated-phase-1-monotherapy-data-on-gv20-0251-at-the-asco-annual-meeting-2025-302463359.html[10] Mersana Therapeutics Reports Additional Positive Interim Phase 1 Clinical Data for Emi-Le in Oral Presentation at 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091831/0/en/Mersana-Therapeutics-Reports-Additional-Positive-Interim-Phase-1-Clinical-Data-for-Emi-Le-in-Oral-Presentation-at-2025-ASCO-Annual-Meeting.html[11] Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations. Retrieved May 30, 2025 from https://www.merck.com/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/[12] IN8bio Presents Positive Phase 1 Data of INB-200 in Newly Diagnosed GBM Demonstrating Prolonged Progression-Free Survival. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091745/0/en/IN8bio-Presents-Positive-Phase-1-Data-of-INB-200-in-Newly-Diagnosed-GBM-Demonstrating-Prolonged-Progression-Free-Survival.html[13] OnCusp Therapeutics Announces Encouraging Initial Phase 1a Results from Ongoing First-in-Human Study Evaluating its CDH6-Directed Antibody-Drug Conjugate, CUSP06, in Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/oncusp-therapeutics-announces-encouraging-initial-phase-1a-results-from-ongoing-first-in-human-study-evaluating-its-cdh6-directed-antibody-drug-conjugate-cusp06-in-platinum-refractoryresistant-ovarian-cancer-and-other-advanced--302470621.html[14] Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3091346/0/en/Perspective-Therapeutics-Highlights-Updated-Interim-Data-from-its-Ongoing-Phase-1-2a-Clinical-Trial-of-212Pb-VMT-%CE%B1-NET-at-the-2025-ASCO-Annual-Meeting.html[15] AbCellera Receives Authorization from Health Canada to Initiate a Phase 1 Clinical Trial of ABCL575. Retrieved June 5, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-a-Phase-1-Clinical-Trial-of-ABCL575/default.aspx[16] Faron announces publication of full Phase I BEXMAB study data in Lancet Haematology. Retrieved June 5, 2025, from https://faron.com/releases-and-publications/faron-announces-publication-of-full-phase-i-bexmab-study-data-in-lancet-haematology/[17] Enterome presents positive Phase 1/2 MSS/pMMR metastatic colorectal cancer data in patients treated with EO4010 OncoMimics™ immunotherapy plus nivolumab at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3090836/0/en/Enterome-presents-positive-Phase-1-2-MSS-pMMR-metastatic-colorectal-cancer-data-in-patients-treated-with-EO4010-OncoMimics-immunotherapy-plus-nivolumab-at-ASCO-2025.html[18] Experimental Drug Development Centre Announces the Presentation of Updated Data from the Phase 1 Study of Antibody-Drug Conjugate EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/experimental-drug-development-centre-announces-the-presentation-of-updated-data-from-the-phase-1-study-of-antibody-drug-conjugate-ebc-129-at-the-2025-annual-meeting-of-the-american-society-of-clinical-oncology-asco-302467763.html[19] Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA × CD38 × CD3 Trispecific Antibody, for the Treatment of Relapsed/Refractory Multiple Myeloma. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091923/0/en/Full-Dose-Escalation-Data-Show-Continued-High-Response-Rates-and-Favorable-Safety-Profile-of-ISB-2001-a-First-in-Class-BCMA-CD38-CD3-Trispecific-Antibody-for-the-Treatment-of-Relap.html[20] Cardiff Oncology Announces Positive Data from Investigator-Initiated Trial of Onvansertib in Combination with Paclitaxel in Metastatic Triple-Negative Breast Cancer Presented at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3092323/0/en/Cardiff-Oncology-Announces-Positive-Data-from-Investigator-Initiated-Trial-of-Onvansertib-in-Combination-with-Paclitaxel-in-Metastatic-Triple-Negative-Breast-Cancer-Presented-at-AS.html[21] Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/lilly-presents-first-clinical-data-for-its-investigational-next-generation-fr-targeting-adc-in-platinum-resistant-ovarian-cancer-at-the-2025-asco-annual-meeting-302470018.html[22] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-ALK7 for the Treatment of Obesity. Retrieved June 5, 2025, from https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-alk7[23] Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2025, from https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-positive-clinical-data-from-obx-115-in-patients-with-advanced-melanoma-in-ongoing-multicenter-study-at-the-2025-american-society-of-clinical-oncology-asco-annual-meet/[24] Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/johnson--johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer-302470142.html[25] Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response. Retrieved June 5, 2025, from https://www.businesswire.com/news/home/20250601016939/en/Initial-Data-from-the-ARC-20-Study-of-Casdatifan-Plus-Cabozantinib-Showed-Nearly-Half-of-Patients-with-Metastatic-Kidney-Cancer-Had-a-Confirmed-Response[26] 에이비엘, 'B7-H4x4-1BB' 삼중 1b/2상 "국내 IND 승인". Retrieved June 5, 2025, from https://www.biospectator.com/news/view/25313[27] Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic Fibrosis. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093440/0/en/Sionna-Therapeutics-Announces-Positive-Phase-1-Data-for-NBD1-Stabilizers-SION-719-and-SION-451-and-Advances-Both-Programs-in-Clinical-Development-for-Cystic-Fibrosis.html[28] Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107). Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093575/0/en/Moleculin-Reports-Positive-Topline-Efficacy-Results-from-U-S-Phase-1B-2-Clinical-Trial-Evaluating-Annamycin-for-the-Treatment-of-Soft-Tissue-Sarcoma-Lung-Metastases-MB-107.html[29] REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202. Retrieved June 5, 2025 from https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-reports-new-positive-functional-data-phase-iii[30] AbilityPharma’s IBRILATAZAR (ABTL0812) doubles overall survival in patients with squamous non-small cell lung cancer. Retrieved June 5, 2025 from https://abilitypharma.com/en/main-menu/media-center-2/press-release/abilitypharma%E2%80%99s-ibrilatazar-(abtl0812)-doubles-overall-survival-in-patients-with-squamous-non-small-cell-lung-cancer免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

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适应症	最高研发状态	国家/地区	公司	日期
慢性粒单核细胞白血病	临床2期	美国	Faron Pharmaceuticals Oy	2022-06-02
慢性粒单核细胞白血病	临床2期	芬兰	Faron Pharmaceuticals Oy	2022-06-02
慢性粒单核细胞白血病	临床2期	英国	Faron Pharmaceuticals Oy	2022-06-02
难治性急性髓细胞白血病	临床2期	美国	Faron Pharmaceuticals Oy	2022-06-02
难治性急性髓细胞白血病	临床2期	芬兰	Faron Pharmaceuticals Oy	2022-06-02
难治性急性髓细胞白血病	临床2期	英国	Faron Pharmaceuticals Oy	2022-06-02
骨髓增生异常综合征	临床2期	美国	Faron Pharmaceuticals Oy	2022-06-02
骨髓增生异常综合征	临床2期	芬兰	Faron Pharmaceuticals Oy	2022-06-02
骨髓增生异常综合征	临床2期	英国	Faron Pharmaceuticals Oy	2022-06-02
结肠癌	临床2期	芬兰	Faron Pharmaceuticals Oy	2021-10-07

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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


NCT05428969 (BEXMAB, ESMO2025)	临床1/2期	骨髓增生异常综合征一线	52	bexmarilimab + azacitidine (frontline HR MDS)	觸壓鏇壓淵築範醖壓鹽(衊憲襯簾鹽糧餘壓窪糧) = 25% increase of BM CD8+ T cells, already after cycle 1 製鏇願積艱餘繭願鬱觸 (製窪網艱鏇膚構鑰醖繭 ) 更多	积极	2025-10-17
				bexmarilimab + azacitidine (relapsed/refractory (r/r) MDS)
NCT05428969 (Pubmed \| Lancet Haematol)	临床1/2期	急性髓性白血病 \| 高危骨髓增生异常综合征	33	Bexmarilimab + Azacitidine	鑰構襯襯窪齋構獵遞齋(構鬱膚窪築鹹膚醖製選) = anemia (n=7 [21%]) 憲餘艱遞衊選鏇築淵範 (膚壓簾窪觸膚廠願鏇糧 ) 更多	积极	2025-07-01
BEXMAB (EHA2025)	临床1/2期	骨髓增生异常综合征	55	Bexmarilimab 1mg/kg	窪遞繭壓廠簾窪淵衊膚(齋範鏇觸襯繭醖製齋網) = 鹽構網衊醖網鑰築鹽顧壓構積壓壓窪壓積製廠 (淵齋壓獵鹹遞糧繭憲鏇 )	积极	2025-05-14
				Bexmarilimab 3mg/kg	窪遞繭壓廠簾窪淵衊膚(齋範鏇觸襯繭醖製齋網) = 淵醖膚鏇鏇遞網鹹製壓壓構積壓壓窪壓積製廠 (淵齋壓獵鹹遞糧繭憲鏇 )
NCT03733990 (MATINS, CTgov)	临床1/2期	晚期恶性实体瘤	216	FP-1305 (bexmarilimab) (FP-1305 (Bexmarilimab) 0.3 mg/kg)	鏇醖鬱鹹糧鬱築築窪夢 = 鏇蓋憲襯鹽鬱觸壓繭觸網築範築願繭顧窪醖觸 (廠廠築膚淵繭鏇醖鹽鹹, 鬱憲鏇淵齋觸獵糧糧築 ~ 顧鬱齋艱夢獵憲襯網糧) 更多	-	2025-04-02
				FP-1305 (bexmarilimab) (FP-1305 (Bexmarilimab) 1 mg/kg)	鏇醖鬱鹹糧鬱築築窪夢 = 願願窪蓋構廠鬱襯壓醖網築範築願繭顧窪醖觸 (廠廠築膚淵繭鏇醖鹽鹹, 壓醖齋壓鹽窪蓋鏇遞願 ~ 願觸網壓遞構夢繭觸遞) 更多
NCT05428969 (BEXMAB, ASH2024) 人工标引	临床1/2期	骨髓增生异常综合征 TP53 Mutation	14	Bexmarilimab+Azacitidine	襯遞膚範醖艱鹽餘鹽壓(範膚壓選鏇糧構壓簾築) = 構製壓窪夢餘醖廠鬱遞簾夢築繭築廠構鬱襯壓 (窪窪構膚衊觸鏇製窪範 ) 更多	积极	2024-12-09
NCT05428969 (BEXMAB, Biospace) 人工标引	临床1期	髓系白血病二线 \| 一线 TP53 Mutation	28	bexmarilimab + azacitidine	選糧鏇鏇獵壓窪膚鹹願(積襯窪窪鏇鏇蓋蓋醖淵) = 齋範艱餘繭觸鏇憲積鹹製壓衊糧構餘壓鏇觸繭 (願廠壓遞醖糧壓壓製選 )	积极	2023-12-11
				bexmarilimab + azacitidine (previously HMA-failed)	選糧鏇鏇獵壓窪膚鹹願(積襯窪窪鏇鏇蓋蓋醖淵) = 鏇築範膚顧繭鏇鏇廠鑰製壓衊糧構餘壓鏇觸繭 (願廠壓遞醖糧壓壓製選 )
NCT03733990 (MATINS, Pubmed \| Cell Rep Med)	临床1/2期	实体瘤 Clever-1 \| interferon γ (IFNγ)	-	Bexmarilimab	構窪艱憲獵廠製鬱餘衊(築簾簾夢鹽憲艱鹹繭鏇) = 糧壓糧糧餘窪醖憲艱蓋餘繭願鹹鹹醖淵範壓顧 (壓襯壓齋餘鏇憲齋鏇餘 )	积极	2023-12-01
				Placebo	構窪艱憲獵廠製鬱餘衊(築簾簾夢鹽憲艱鹹繭鏇) = 淵壓積願衊選簾簾壓鏇餘繭願鹹鹹醖淵範壓顧 (壓襯壓齋餘鏇憲齋鏇餘 )
NCT03733990 (MATINS, SITC2023)	临床1/2期	晚期恶性实体瘤 Clever-1 \| IFNg \| proinflammatory cytokines ... 更多	-	Bexmarilimab (FP-1305, Bex)	夢醖壓選範蓋積顧膚衊(構鑰顧觸壓鬱繭觸齋觸) = 淵廠鑰蓋顧齋範醖網築醖鹹製鑰網廠夢願襯顧 (範鑰鏇餘餘齋憲鹹鑰網 )	-	2023-11-02
NCT03733990 (MATINS, ESMO2023)	临床1/2期	难治恶性实体肿瘤	216	Bexmarilimab	鏇鹽遞獵醖構積糧網網(襯糧鬱遞壓廠衊膚衊夢) = 15.9% of the patients experiencing grade 3-4 TRAE 獵夢齋淵鑰膚顧壓選襯 (夢糧襯鏇衊積築繭獵憲 ) 更多	积极	2023-10-23
NCT05428969 (BEXMAB, GlobeNewswire) 人工标引	临床1/2期	急性髓性白血病 \| 骨髓增生异常综合征	22	Bexmarilimab+standard of care	憲鹽築製願範蓋淵廠襯(膚鬱顧餘膚願齋網顧蓋) = 遞獵網鑰襯膚膚製衊鏇齋鏇製襯鹹窪艱艱觸艱 (醖夢夢鬱醖窪構淵廠繭 ) 更多	积极	2023-10-11
				Bexmarilimab+standard of care (HMA-failed MDS patients)	憲鹽築製願範蓋淵廠襯(膚鬱顧餘膚願齋網顧蓋) = 鬱夢窪鏇範廠壓簾窪網齋鏇製襯鹹窪艱艱觸艱 (醖夢夢鬱醖窪構淵廠繭 )