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更新于：2026-10-23

Tagraxofusp-ERZS

更新于：2026-10-23

概要

概要

基本信息

药物类型

融合蛋白

别名

Diphtheria toxin-il-3 fusion protein targeting IL-3 receptor、Diphtheria-toxin-interleukin-3-fusion-protein、Tagraxofusp

+ [10]

靶点

CD123

作用方式

抑制剂

作用机制

CD123抑制剂(白细胞介素-3受体α亚基抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

Blastic浆细胞样树突状细胞肿瘤CD123阳性急性髓性白血病急性髓性白血病+ [7]

非在研适应症

伴有骨髓发育不良相关变化的急性髓系白血病淋巴母细胞淋巴瘤多发性骨髓瘤+ [6]

原研机构

Texas A&M University

在研机构

Stemline Therapeutics, Inc.

The University of Texas MD Anderson Cancer CenterMenarini Von Heyden GmbH

+ [1]

非在研机构

The University of Texas Southwestern Medical Center

权益机构

A.Menarini Industrie Farmaceutiche Riunite Srl

Nippon Shinyaku Co., Ltd.Menarini Von Heyden GmbH

最高研发阶段批准上市

首次获批日期

美国 (2018-12-21),

Blastic浆细胞样树突状细胞肿瘤

最高研发阶段(中国)-

特殊审评孤儿药 (美国)、孤儿药 (日本)、孤儿药 (澳大利亚)、突破性疗法 (美国)

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结构/序列

Sequence Code 453129448

来源: *****

关联

项与 Tagraxofusp-ERZS 相关的临床试验

NCT07148180

/ Recruiting临床1/2期IIT

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence.
The names of the study drugs involved in this study are:
* Tagraxofusp (a type of CD123-directed cytotoxin)
* Azacitidine (a type of standard of care cytidine nucleoside analog)
* Venetoclax (a type of standard of care BCL-2 inhibitor)

开始日期2026-02-02

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT07007052

/ Recruiting临床2期IIT

Open Label Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients

The goal of this clinical trial is to study the efficacy of the tagraxofusp + venetoclax combination in treatment-naive blastic plasmacytoid dendritic cell neoplasm adult patients.
The main question is to verify the response in patients after 3 cycles of tagraxofusp+venetolax and to demonstrate if the combination of tagraxofusp + venetoclax increases the rate of complete remission, assessed after 3 months of treatment.
Patients will receive a ramp-up phase of venetoclax during 3 days and at least 3 cycles of venetoclax. After, the investigators will evaluate the response, and depending on the response observed, patients may receive additional cycles of treatment for a maximum of 24 cycles, or receive an allograft or discontinue the treatment in the case of therapeutic failure.

开始日期2025-12-11

申办/合作机构

Stemline Therapeutics, Inc.

[+1]

NCT06414681

/ Recruiting早期临床1期

An Open Label Pilot Trial of the Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined

The goal of this open-label, single-center, pilot trial is to test the combination of Tagraxofusp (TAG) with Pacritinib (PAC) in patients with intermediate-II or higher myelofibrosis (MF), who have had prior therapy with the approved JAK1/2 inhibitor or in which therapy with the approved JAK1/2 inhibitors is not appropriate, contraindicated or declined by the subjects.
The Primary Objective is to:
1. Characterized efficacy of the combination of Tagraxofusp and Pacritinib.
The Secondary Objective is to:
1. characterize the safety profile of the combination Tagraxofusp and Pacritinib.
2, Characterize the feasibility of the combination Tagraxofusp and Pacritinib. 3. Characterize hematologic improvement with the combination Tagraxofusp and Pacritinib.
4. Evaluate and compare the effect of Tagraxofusp and Pacritinib on participant reports of MF symptoms.
Exploratory:
Pharmacokinetic (PK) testing of Tagraxofusp and Pacritinib to assess clinical predictors of response.
Next Generation Sequencing (NGS) Testing to define the number and the allele burden of pathological mutations, as well as the changes over the course of therapy, both in regard to progression and response.
Blood will be collected and stored at KU BRCF for future study related PK analysis

开始日期2025-08-25

申办/合作机构

University of Kansas Medical Center

100 项与 Tagraxofusp-ERZS 相关的临床结果

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100 项与 Tagraxofusp-ERZS 相关的转化医学

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100 项与 Tagraxofusp-ERZS 相关的专利（医药）

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217

项与 Tagraxofusp-ERZS 相关的文献（医药）

2026-09-01·Clinical Lymphoma Myeloma & Leukemia

Blastic Plasmacytoid Dendritic Cell Neoplasm in the Dual CD123-targeted Therapy Era: A Clinical Decision Review of Treatment Selection, Sequencing, CNS Management, and Transplant Integration

Review

作者: Chen, Haimin ; Zhou, Fan ; Fei, Xichang ; Zhang, Ying

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) has entered a dual CD123-targeted therapy era following the availability of tagraxofusp and the 2026 approval of pivekimab sunirine-pvzy. This development creates a new clinical problem: treatment can no longer be selected solely by distinguishing targeted therapy from conventional chemotherapy; clinicians must choose between mechanistically distinct CD123 platforms while integrating central nervous system (CNS) management, transplantation, comorbidity, organ function, and prior treatment. This narrative review reframes BPDCN around those decisions. It summarizes the minimum diagnostic and staging information needed before therapy; compares tagraxofusp and pivekimab using response, survival, follow-up, and transplant-bridging data; and proposes scenario-based approaches for newly diagnosed, older or frail, transplant-eligible, and relapsed or refractory patients. Tagraxofusp has the longest disease-specific experience and a defined role as remission induction and a bridge to hematopoietic cell transplantation, but capillary leak syndrome requires stringent selection and cycle-1 monitoring. Pivekimab offers a distinct antibody-drug conjugate platform with once-every-3-week dosing and activity in both treatment-naive and relapsed disease, but hepatotoxicity, including hepatic veno-occlusive disease, is a central limitation. Neither agent has established CNS-protective activity. Baseline cerebrospinal fluid assessment and routine prophylactic intrathecal chemotherapy for CSF-negative patients should therefore be distinguished from intensified therapeutic intrathecal treatment for documented CNS involvement. Early donor search, multidimensional response evaluation, and trial enrollment remain integral. The proposed algorithm is evidence-informed rather than guideline-mandated and highlights where prospective studies are most urgently needed.

2026-09-01·FOOD CHEMISTRY

Structure and antioxidant characteristics of diacylglycerol-based oleogels: A comparison with triacylglycerol systems

Article

作者: Wang, Xiuxiu ; Jia, Min ; Zhang, Xiaoqing ; Xu, Tongcheng ; Yue, Hao ; Li, Baorui ; Du, Fangling ; Zong, Aizhen

This study compared the effects of γ-oryzanol/β-sitosterol combined with monoglyceride (MAG) as composite gelators on soybean diacylglycerol (DAG) and triacylglycerol (TAG)-based oleogels. Results showed that TAG and DAG systems formed stable oleogels with high mechanical strength at γ-oryzanol/β-sitosterol concentrations of 4% and 8%, respectively. The subsequent addition of 1% MAG significantly reduced gel hardness (more pronounced in DAG), while the oil-binding capacity remained largely unaffected. Microstructural and FTIR analyses revealed that MAG transformed the crystal shape of DAG and TAG-based oleogels from a needle-like arrangement to clustered networks, and the intermolecular interactions were primarily driven by van der Waals forces. Accelerated oxidation demonstrated that while DAG exhibited higher oxidation rates than TAG in liquid and oleogels, the DAG composite gel displayed enhanced oxidative stability compared to γ-oryzanol/β-sitosterol only systems. These findings clarify the differences between DAG and TAG based oleogels, demonstrating the potential for MAG-phytosterol composite oleogels in functional foods.

2026-09-01·LEUKEMIA

Decreased TXNRD1 is associated with resistance to tagraxofusp in blastic plasmacytoid dendritic cell neoplasms, as seen in phase II

Article

作者: Song, Xingzhi ; Chen, Janice ; Estecio, Marcos R ; Kannan, Sankaranarayanan ; Olguin, Arturo ; Little, Latasha ; Liu, Jingjing ; Cai, Tianyu ; Zhang, Jianhua ; Andreeff, Michael ; Gupta, Saurabh Kumar ; Futreal, P Andrew ; Brooks, Christopher ; Abbas, Hussein A ; Singh, Sandeep ; Cotton, Jennifer L ; Gumbs, Curtis ; Pemmaraju, Naveen ; Desai, Poonam ; Beird, Hannah C ; Kantarjian, Hagop ; Konopleva, Marina ; Han, Lina

Tagraxofusp is a CD123-targeted therapy comprised of a recombinant human interleukin-3 (IL-3) fused to a truncated diphtheria toxin payload. It is the first approved treatment specifically for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). To identify biomarkers of response, bone marrow samples from 12 BPDCN patients who were treated with tagraxofusp in the pivotal phase II trial (NCT02113982) were profiled longitudinally using a gene panel and single-cell RNA sequencing. Residual tumor cells following tagraxofusp expressed lower levels of TXNRD1 that would reduce the efficacy of tagraxofusp. In support of this, enzymatic inhibition of TXNRD1 resulted in higher viability of CAL-1 BPDCN cells following tagraxofusp. Responders had either wild-type or missense TET2 mutations, while transient and non-responders had at least one truncating TET2 mutation. Examples of these mutations within the catalytic domain of TET2 were constructed and transduced into cells. Missense and truncating mutants displayed reduced sensitivities to hypomethylating agents and prolonged S-phase stasis. These results suggest that the levels of TXNRD1 interact with intrinsic TET2 truncating mutations within the bone marrow to modulate patient response to tagraxofusp.

项与 Tagraxofusp-ERZS 相关的新闻（医药）

2026-10-22

·动脉网

Georgiamune与 Menarini集团就首创新类口服免疫肿瘤药物 GIM-621达成独家全球许可与合作协议Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621, a First-in-Class Oral Immuno-Oncology Agent

GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. GIM-621 是一款处于临床前阶段的同类首创口服小分子免疫疗法，具有在多种实体瘤中应用的潜力。Georgiamune to receive $45 million in upfront and near-term payments, as part of a total deal value of up to $1.1 billion, plus royalties. Georgiamune 将获得4,500万美元的预付款及近期付款，作为总交易价值高达11亿美元（另加特许权使用费）的一部分。FLORENCE, Italy and GAITHERSBURG, Md. 意大利佛罗伦萨和马里兰州盖瑟斯堡, ，Oct. 22, 2026 2026年10月22日/PRNewswire/ -- TheMenarini Group ('Menarini'), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ('Stemline'), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Georgiamune Inc., a clinical-stage biotechnology company discovering and developing first-in-class therapies that reprogram immune signaling pathways to treat cancer and autoimmune diseases, today announced an exclusive worldwide license and collaboration agreement for GIM-621.. /美通社/ -- 国际领先的制药与诊断公司美纳里尼集团（“美纳里尼”），及其专注于为癌症患者提供变革性肿瘤治疗的全资子公司Stemline Therapeutics, Inc.（“Stemline”），连同临床阶段生物技术公司Georgiamune Inc.（该公司致力于发现和开发首创疗法，通过重编程免疫信号通路来治疗癌症和自身免疫性疾病），今日宣布就GIM-621达成一项全球独家许可与合作协议。GIM-621 is a preclinical-stage first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. It is one of multiple therapeutic candidates generated from Georgiamune's research into novel mechanisms governing immune activation, suppression and homeostasis. GIM-621 是一款处于临床前阶段的同类首创口服小分子免疫疗法，具有在多种实体瘤中应用的潜力。它是 Georgiamune 公司基于对调控免疫激活、抑制及稳态的新机制的研究而开发的多个候选治疗药物之一。Under the terms of the license and collaboration agreement, Stemline receives an exclusive, worldwide license to develop, manufacture and commercialize GIM-621. Georgiamune will receive $45 million in upfront and near-term payments. Georgiamune is also eligible for preclinical, development, regulatory and commercial milestone payments, for a total potential deal value of up to $1.1 billion, plus royalties.. 根据许可与合作协议的条款，Stemline 获得开发、生产和商业化 GIM-621 的独家全球许可。Georgiamune 将获得 4,500 万美元的预付款及近期付款。Georgiamune 还有资格获得临床前、开发、监管和商业里程碑付款，交易总潜在价值高达 11 亿美元，外加特许权使用费。'At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,' said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. 'GIM-621 is one of multiple programs to emerge from that work, alongside three programs already in clinical development across autoimmune disease and oncology. Georgiamune 创始人兼首席执行官 Samir N. Khleif 博士表示：“在 Georgiamune，我们致力于揭示调控免疫细胞功能的新机制，并将这些生物学发现转化为针对自身免疫性疾病和肿瘤学的首创药物。GIM-621 是源自这一工作的多个项目之一，与此同时，我们还有三个项目已在自身免疫性疾病和肿瘤学领域进入临床开发阶段。”This agreement brings Menarini's global oncology development and commercial capabilities to GIM-621 while allowing Georgiamune to continue advancing a broad pipeline built on distinct immune mechanisms.'. 该协议将美纳里尼的全球肿瘤研发和商业化能力赋予GIM-621，同时允许Georgiamune继续推进基于独特免疫机制的广泛产品管线。'We are delighted to partner with Georgiamune, a company with deep expertise in immuno-oncology which has led to the discovery of GIM-621, a first-in-class oral immunotherapy with promise across multiple solid tumors,' said Elcin Barker Ergun, CEO of the Menarini Group. 'This program is a strong complement to our solid tumor portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress. 美纳里尼集团首席执行官埃尔钦·巴克·埃尔贡表示：“我们很高兴与在免疫肿瘤学领域拥有深厚专业知识的Georgiamune公司合作，这一合作促成了GIM-621的发现。GIM-621是一种首创的口服免疫疗法，在多种实体瘤治疗中展现出广阔前景。该项目有力地补充了我们的实体瘤产品组合，而我们在肿瘤学开发和商业化方面的成熟能力，也将为我们加速其进展提供有力支撑。”We look forward to working closely with the Georgiamune team to unlock the full potential of this innovative approach to benefit patients with cancer.'. 我们期待与 Georgiamune 团队紧密合作，充分释放这一创新方法的潜力，以造福癌症患者。About Georgiamune 关于 GeorgiamuneGeorgiamune is a clinical-stage biotechnology company discovering and developing first-in-class therapies designed to reprogram immune signaling pathways to treat cancer and autoimmune disease. The company's research focuses on novel mechanisms that govern T-cell activation, regulatory T-cell function and immune homeostasis. Georgiamune 是一家处于临床阶段的生物技术公司，致力于发现并开发首创疗法，旨在通过重编程免疫信号通路来治疗癌症和自身免疫性疾病。该公司的研究聚焦于调控 T 细胞活化、调节性 T 细胞功能以及免疫稳态的新颖机制。Georgiamune has three clinical-stage programs: GIM-407, an oral Treg activator in autoimmune disease; GIM-122, a dual-functioning antibody in oncology; and GIM-531, an oral Treg inhibitor in oncology. Georgiamune is also advancing a broader pipeline of preclinical candidates across oncology and autoimmune disease, including GIM-621. Georgiamune 拥有三个处于临床阶段的项目：GIM-407，一种用于自身免疫性疾病的口服调节性T细胞（Treg）激活剂；GIM-122，一种用于肿瘤治疗的双功能抗体；以及 GIM-531，一种用于肿瘤治疗的口服调节性T细胞（Treg）抑制剂。Georgiamune 还在推进更广泛的临床前候选药物管线，涵盖肿瘤学和自身免疫性疾病领域，其中包括 GIM-621。The company was founded by Dr. Samir N. Khleif based on discoveries from his laboratory into mechanisms that control immune responses. For more information, visit . 该公司由萨米尔·N·赫莱夫博士创立，基于其实验室在控制免疫反应机制方面的发现。欲了解更多信息，请访问。www.georgiamune.com www.georgiamune.com. 。About The Menarini Group 关于美纳里尼集团The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. 美纳里尼集团是一家领先的国际制药和诊断公司，营业额达55亿美元，拥有超过17,000名员工。美纳里尼专注于存在高度未满足需求的治疗领域，其产品涵盖心脏病学、肿瘤学、肺病学、胃肠病学、传染病、糖尿病学、炎症和镇痛等领域。With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit . 美纳里尼拥有18个生产基地和9个研发中心，其产品遍布全球140个国家。如需更多信息，请访问。www.menarini.com www.menarini.com. 。About Stemline Therapeutics Inc. 关于 Stemline Therapeutics Inc.Stemline Therapeutics, Inc. ('Stemline'), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline Therapeutics, Inc.（“Stemline”）是美纳里尼集团（Menarini Group）的全资子公司，是一家处于商业化阶段的生物制药公司，专注于为患者带来具有变革意义的肿瘤治疗药物。Stemline 在美国、欧洲及其他全球地区商业化推广 elacestrant，这是一种口服内分泌疗法，适用于治疗雌激素受体（ER）阳性、人表皮生长因子受体 2（HER2）阴性、ESR1 突变的晚期或转移性乳腺癌的绝经后女性或成年男性患者，且这些患者在至少接受过一线内分泌治疗后出现疾病进展。Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. Stemline 还在美国、欧洲及其他全球地区商业化 tagraxofusp-erzs，这是一种针对 CD123 的新型靶向疗法，适用于患有母细胞性浆细胞样树突状细胞肿瘤（BPDCN，一种侵袭性血液癌症）的患者。此外，Stemline 还在欧洲商业化 selinexor，这是一种用于多发性骨髓瘤的 XPO1 抑制剂。The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.. 该公司还在开展多项标签扩展研究，分别针对乳腺癌和血液肿瘤适应症，使用elacestrant和tagraxofusp。此外，它还拥有广泛的临床管线，包括处于不同开发阶段的多种候选药物，用于应对多种实体瘤和血液肿瘤。21 二十一% %more press release views with 更多新闻稿浏览量，借助Request a Demo 申请演示

引进/卖出免疫疗法

2026-10-22

·Firstwordpharma

Menarini bets $1.1B on Georgiamune's preclinical oral immunotherapy

Italy's Menarini has struck a global licensing deal with US biotech Georgiamune centred on GIM-621, a preclinical-stage small molecule designed to harness the immune system against several types of solid tumours.Georgiamune will receive $45 million in upfront and near-term payments, with the deal's total value reaching $1.1 billion if the potential first-in-class drug clears a series of milestones. The biotech is also eligible for royalties on future sales."This programme is a strong complement to our solid tumour portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress," stated Elcin Barker Ergun, chief executive at Menarini, in a release Thursday.The Italian pharma's oncology portfolio includes the oral selective oestrogen receptor degrader (SERD) Orserdu (elacestrant) for breast cancer, and Elzonris (tagraxofusp), a CD123-directed cytotoxin and fusion protein for blastic plasmacytoid dendritic cell neoplasm.Stemline Therapeutics, Menarini's wholly owned oncology subsidiary, will gain exclusive worldwide rights to develop, manufacture and commercialise GIM-621. The companies haven't revealed its molecular target or specific indications, nor did they give a timeline as to when the programme would move into clinical testing.Georgiamune, whose work focuses on mechanisms governing immune activation, suppression and homeostasis, is advancing three clinical-stage programmes of its own. These include GIM-407, an oral regulatory T-cell (Treg) activator for autoimmune diseases; GIM-531, an oral Treg inhibitor in oncology; and GIM-122, a dual-functioning antibody being developed for oncology as well.The Maryland-based biotech completed a $75-million series A round in 2023.

引进/卖出免疫疗法

2026-10-22

·BioSpace

Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621, a First-in-Class Oral Immuno-Oncology Agent

GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. Georgiamune to receive $45 million in upfront and near-term payments, as part of a total deal value of up to $1.1 billion, plus royalties. FLORENCE, Italy and GAITHERSBURG Md., Oct. 22, 2026 (GLOBE NEWSWIRE) -- The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Georgiamune Inc., a clinical-stage biotechnology company discovering and developing first-in-class therapies that reprogram immune signaling pathways to treat cancer and autoimmune diseases, today announced an exclusive worldwide license and collaboration agreement for GIM-621. GIM-621 is a preclinical-stage first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. It is one of multiple therapeutic candidates generated from Georgiamune’s research into novel mechanisms governing immune activation, suppression and homeostasis. Under the terms of the license and collaboration agreement, Stemline receives an exclusive, worldwide license to develop, manufacture and commercialize GIM-621. Georgiamune will receive $45 million in upfront and near-term payments. Georgiamune is also eligible for preclinical, development, regulatory and commercial milestone payments, for a total potential deal value of up to $1.1 billion, plus royalties. “At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three programs already in clinical development across autoimmune disease and oncology. This agreement brings Menarini’s global oncology development and commercial capabilities to GIM-621 while allowing Georgiamune to continue advancing a broad pipeline built on distinct immune mechanisms.” "We are delighted to partner with Georgiamune, a company with deep expertise in immuno-oncology which has led to the discovery of GIM-621, a first-in-class oral immunotherapy with promise across multiple solid tumors," said Elcin Barker Ergun, CEO of the Menarini Group. "This program is a strong complement to our solid tumor portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress. We look forward to working closely with the Georgiamune team to unlock the full potential of this innovative approach to benefit patients with cancer." About Georgiamune Georgiamune is a clinical-stage biotechnology company discovering and developing first-in-class therapies designed to reprogram immune signaling pathways to treat cancer and autoimmune disease. The company’s research focuses on novel mechanisms that govern T-cell activation, regulatory T-cell function and immune homeostasis. Georgiamune has three clinical-stage programs: GIM-407, an oral Treg activator in autoimmune disease; GIM-122, a dual-functioning antibody in oncology; and GIM-531, an oral Treg inhibitor in oncology. Georgiamune is also advancing a broader pipeline of preclinical candidates across oncology and autoimmune disease, including GIM-621. The company was founded by Dr. Samir N. Khleif based on discoveries from his laboratory into mechanisms that control immune responses. For more information, visit About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit . About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. Contacts Thermal for Georgiamune Inc. media@georgiamune.com The Menarini Group Valeria Speroni Cardi Email: pressoffice@menarini.com Stemline Therapeutics, Inc. Cheya Pope Email: media@menarinistemline.com

100 项与 Tagraxofusp-ERZS 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11358	Tagraxofusp-ERZS	L01XX67	DB14731

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
Blastic浆细胞样树突状细胞肿瘤	美国	Stemline Therapeutics, Inc.	2018-12-21

未上市

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
复发性急性髓细胞白血病	临床2期	美国	Stemline Therapeutics, Inc.	2025-02-10
CD123阳性急性髓性白血病	临床2期	美国	Stemline Therapeutics, Inc.	2025-01-14
CD123阳性急性髓性白血病	临床2期	澳大利亚	Stemline Therapeutics, Inc.	2025-01-14
急性髓性白血病	临床2期	美国	Stemline Therapeutics, Inc.	2024-05-01
骨髓增生性疾病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2022-03-04
淋巴母细胞淋巴瘤	临床2期	美国	The University of Texas MD Anderson Cancer Center	2022-02-17
复发性 B 细胞急性淋巴细胞白血病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2022-02-17
难治性 B 细胞急性淋巴细胞白血病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2022-02-17
难治性 T 急性淋巴细胞白血病	临床2期	美国	The University of Texas MD Anderson Cancer Center	2022-02-17
原发性骨髓纤维化	临床2期	意大利	Menarini Von Heyden GmbH	2022-01-30

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临床结果

适应症

分期

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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


NCT04216524 (ASCO2026)	临床2期	Blastic浆细胞样树突状细胞肿瘤一线	19	Tagraxofusp+Hyper-CVAD+Venetoclax (newly diagnosed)	積糧積窪壓範襯艱選齋(簾蓋糧鑰鬱餘鏇齋鹹獵) = The most common any grade adverse events (AE) were edema (n = 13) and fatigue (n = 11). There were 2 grade 5 AE (progression, respiratory failure). 鏇願衊構廠齋製選膚夢 (夢憲醖襯願夢選網壓蓋 ) 更多	积极	2026-05-29
				Tagraxofusp+Hyper-CVAD+Venetoclax (relapsed/refractory)
NCT04216524 (EHA2026)	临床2期	Blastic浆细胞样树突状细胞肿瘤一线	19	Tagraxofusp+Hyper-CVAD+Venetoclax (Newly Diagnosed)	願襯願鹹鏇顧餘鹽夢糧(鏇顧艱鹽廠願齋鏇窪築) = Any grade capillary leak syndrome (CLS) was seen in 2 pts (10%); both grade 3 衊憲廠襯網襯夢築顧製 (鑰淵獵獵遞餘鏇獵夢蓋 ) 更多	积极	2026-05-21
				Tagraxofusp+Hyper-CVAD+Venetoclax (Relapsed/Refractory)
EHA2026	N/A	Blastic浆细胞样树突状细胞肿瘤一线	94	TAGRAXOFUSP	餘顧壓艱鹽衊廠糧獵選(鑰窪選鏇製餘膚構夢製) = 觸築夢淵窪製獵憲艱憲範積築鬱淵遞糧窪襯窪 (積鑰窪淵夢選選獵願窪 ) 更多	积极	2026-05-12
				VENETOCLAX	餘顧壓艱鹽衊廠糧獵選(鑰窪選鏇製餘膚構夢製) = 淵淵艱糧鬱觸製憲糧鹽範積築鬱淵遞糧窪襯窪 (積鑰窪淵夢選選獵願窪 ) 更多
Tandem Meetings ASTCT and CIBMTR2026	临床1期	CD123阳性血液肿瘤维持 CD123+	13	Tagraxofusp (CD123+ AML/MDS/MF/CMML)	衊憲蓋積鹹鏇鏇艱鏇鹽(繭夢憲醖積選鬱願膚夢) = At D2, two patients developed grade 3 toxicities (transaminitis, abdominal pain, capillary leak with hypoxia), and one had grade 4 thrombocytopenia and elevated AST, meeting DLT criteria. At D3, one patient experienced grade 4 toxicities (transaminitis, thrombocytopenia), meeting DLT criteria and requiring hospitalization and dose reduction. 醖廠顧繭顧網襯膚鬱簾 (憲窪選淵鹹鏇鏇窪憲簾 ) 更多	积极	2026-02-04
NCT03113643 (ASH2025)	临床2期	Blastic浆细胞样树突状细胞肿瘤一线	27	Tagraxofusp+azacitidine+venetoclax (1L)	簾鹹積窪鹽範觸餘餘廠(廠壓鑰窪遞鏇顧顧鬱窪) = 積蓋淵糧簾膚鑰憲醖鏇鬱醖鑰夢積積餘簾膚範 (鑰簾鑰構顧觸顧繭糧憲, 32 ~ 88) 更多	积极	2025-12-06
				Tagraxofusp+azacitidine+venetoclax (relapsed/refractory)	簾鹹積窪鹽範觸餘餘廠(廠壓鑰窪遞鏇顧顧鬱窪) = 網夢鹹鹽製壓廠壓繭淵鬱醖鑰夢積積餘簾膚範 (鑰簾鑰構顧觸顧繭糧憲, 8 ~ 65) 更多
ASH2025	N/A	Blastic浆细胞样树突状细胞肿瘤一线	94	Tagraxofusp (TAG)	構夢廠餘簾齋憲憲醖範(齋糧鹹簾淵蓋鏇衊衊鑰) = 壓壓簾積廠觸憲選壓構構壓壓餘遞網遞廠鹹網 (壓糧艱鏇簾繭襯壓願憲 ) 更多	积极	2025-12-06
				Venetoclax (VEN)	構夢廠餘簾齋憲憲醖範(齋糧鹹簾淵蓋鏇衊衊鑰) = 顧獵廠淵齋廠鬱構製鹽構壓壓餘遞網遞廠鹹網 (壓糧艱鏇簾繭襯壓願憲 ) 更多
ASH2025	N/A	Blastic浆细胞样树突状细胞肿瘤	795	Tagraxofusp	選衊鬱築網鏇製憲膚夢(壓簾醖醖選襯構膚憲壓) = Anemia, thrombocytopenia, neutropenia, and edema were common AEs across LoT1 and LoT2 積簾衊築艱簾鹽窪糧鑰 (壓繭艱艱構鹽網鏇範遞 )	不佳	2025-12-06
NCT05032183 (CTgov)	临床1/2期	复发性 B 细胞急性淋巴细胞白血病 \| 难治性 T 急性淋巴细胞白血病 \| 难治性 B 细胞急性淋巴细胞白血病 ... 更多	4	Pegfilgrastim+Filgrastim-sndz+Methotrexate+Mercaptopurine+Cytarabine+Mesna+Cyclophosphamide+Leucovorin+Prednisone+Dexamethasone+Rituximab+Vincristine+Tagraxofusp-erzs	獵遞膚鹹蓋積襯淵糧憲(廠憲廠簾鑰餘淵網憲繭) = 衊艱衊衊觸獵顧壓選網網壓齋廠積糧選鹽鏇簾 (壓積廠鹹廠製鏇顧簾鹹, 顧壓壓鹽淵範繭製膚膚 ~ 襯襯壓遞顧襯齋艱餘鹽) 更多	-	2025-08-11
NCT02113982 (ASCO2025)	临床1/2期	Blastic浆细胞样树突状细胞肿瘤 CD123	-	Tagraxofusp 12 µg/kg	齋衊餘夢蓋鏇鹽積獵餘(選襯鏇廠簾繭廠蓋衊鏇) = No investigator-assessed CLS was reported, although some pts required dose interruption due to weight gain or hypoalbuminemia 觸選膚鬱糧構淵夢鬱繭 (觸鏇壓齋願構鹹簾築淵 ) 更多	积极	2025-05-30
NCT02113982 (ASCO2025)	临床1/2期	Blastic浆细胞样树突状细胞肿瘤一线 CD123	65	tagraxofusp (HCT-CI low)	觸艱鹹簾蓋衊觸範艱鏇(窪顧鏇鹽願淵簾繭夢鑰) = Two deaths due to CLS occurred in int pts. Grade 3-4 CLS occurred in 0%, 9%, and 4% of pts; all CLS events were in C1 and all grade 1-4 CLS events resolved 壓築鹽醖窪鏇顧願糧製 (積淵衊壓憲膚鏇繭鬱鹹 ) 更多	积极	2025-05-30
				tagraxofusp (HCT-CI intermediate)