Anti-cd47 monoclonal antibody hu5f9-g4、Immunoglobulin g4(225-proline), anti-(human cd47 antigen) (human-mus musculus monoclonal hu5f9-g4 .gamma.4-chain), disulfide with human-mus musculus monoclonal hu5f9-g4 .kappa.-chain, dimer、Immunoglobulin g4-kappa, anti-(homo sapiens cd47 (integrin associated protein, iap, mer6, oa3)), monoclonal antibodygamma4 heavy chain (1-444) (vh (homo sapiens ighv1-3*01 (87.8%)-(ighd)-ighj4*01 (100%)) (8.8.10) (1-117)-homo sapiens ighg4*01 (ch1 (118-2

+ [8]

靶点

CD47

作用方式

抑制剂

作用机制

CD47抑制剂(分化群47抑制剂)

治疗领域

肿瘤神经系统疾病消化系统疾病+ [2]

在研适应症

弥漫内生性脑桥神经胶质瘤弥漫性中线胶质瘤高级别胶质瘤+ [3]

非在研适应症

急性髓性白血病晚期结直肠腺癌晚期恶性实体瘤+ [17]

原研机构

Stanford University

在研机构

Gilead Sciences, Inc.

Ono Pharmaceutical Co., Ltd.

非在研机构-

权益机构

Rocket Pharmaceuticals, Inc.

Gilead Sciences, Inc.

ImmunoGen, Inc.

+ [4]

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

Sequence Code 321801864H

来源: *****

Sequence Code 321801865L

来源: *****

关联

项与莫洛利单抗相关的临床试验

NCT05823480

/ Withdrawn临床1期IIT

A Multi-Center, Phase 1 Trial of Combining Anti-CD47 Antibody (Magrolimab) with Azacitidine As Post-Transplant Maintenance Therapy in Patients Who Underwent Allogeneic Hematopoietic Cell Transplantation for Treatment of High-Risk AML or MDS

This phase I trial studies how well the combination of magrolimab works with azacitidine after a donor stem cell transplant (allogeneic hematopoietic cell transplantation) in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome. Magrolimab is a type of protein called an antibody. It is designed to target and block a protein called CD47. CD47 is present on cancer cells and is used by cancer cells to protect themselves from the body's immune system. Blocking CD47 with magrolimab may enable the body's immune system to find and destroy the cancer cells. Azacitidine is a chemotherapy drug that may prevent the return of acute myeloid leukemia or myelodysplastic syndrome by working in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining magrolimab and azacitidine may kill more cancer cells after allogeneic hematopoietic cell transplantation in patients with high-risk acute myeloid leukemia or myelodysplastic syndromes.

开始日期2024-10-09

申办/合作机构

City of Hope National Medical Center

[+1]

NCT05829434

/ Withdrawn临床2期

Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed "ELN 2022 Intermediate or Adverse-risk" AML or High Risk MDS Patients Intended to Undergo Allogeneic Stem Cell Transplantation, a Phase 2, Single-arm, Open-Label Study

Use of magrolimab in combination with standard intensive chemotherapy ("7+3" or CPX-351) in newly diagnosed "ELN 2022 intermediate or adverse-risk" AML or high risk MDS patients, who intend to undergo allogeneic stem cell transplantation

开始日期2024-03-31

申办/合作机构

Universität Leipzig

[+1]

NCT05807126

/ Withdrawn临床1期IIT

A Phase I/Ib Study of Anti-CD47 Hu5F9-G4 (Magrolimab) in Combination With Olaparib in Patients With BRCA1/2-Mutant Tumors

This phase I/Ib trial studies the side effects and best dose of Hu5F9-G4 (magrolimab) when given in combination with olaparib for the treatment of patients with breast or castrate-resistant prostate cancer that have spread from where they first started (primary site) to other places in the body (metastatic) or have come back after a period of improvement (recurrent) and have mutations in the BRCA1/2 genes. Magrolimab is a monoclonal antibody with potential anticancer activity and the cability to stimulate the immune system and may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Combination therapy with magrolimab and olaparib may be safe and effective in treating BRCA-mutated metastatic or recurrent breast or castrate-resistant prostate cancer.

开始日期2024-03-05

申办/合作机构

National Cancer Institute

100 项与莫洛利单抗相关的临床结果

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100 项与莫洛利单抗相关的转化医学

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100 项与莫洛利单抗相关的专利（医药）

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项与莫洛利单抗相关的文献（医药）

2024-12-01·LEUKEMIA

Managing the unmanageable: evidence-driven approaches to real-world patient prototypes of TP53-mutant myelodysplastic neoplasms and acute myeloid leukemia

Review

作者: Patel, Shyam A ; Patel, Shyam A.

Patients with TP53 aberrations comprise the highest risk subset of all myeloid malignancies. The managerial conundrum of TP53-mutant myelodysplastic neoplasms (MDS) and acute myeloid leukemia (AML) stems from refractoriness to or relapse after conventional chemotherapy, as well as the limited translational success of investigational therapies targeting TP53-mutant cells. Thus far, no targeted therapies have been commercially approved for this mutational subset. As a result, management plans for patients with TP53-mutant MDS and AML are often driven by clinical judgment and/or physician preference rather than consensus guidelines backed by a rigorous evidence basis. This clinical case-based, evidence-driven review highlights the most salient data that guides the management of commonly encountered patient prototypes. This review discusses the therapeutic menu of first-line options that derive from multi-institutional experiences as well as from disease-centric consortia and discusses how these first-line options can be optimally tailored to heterogeneous groups of patients. The debate regarding whether allogeneic stem cell transplant should be offered to these patients is summarized. Finally, this review explores the recent unfortunate news of pauses in clinical trials for the leading investigational agents - eprenetapopt, magrolimab, sabatolimab, and idasanutlin - and offers solutions toward re-invigorating the pipeline of precision therapeutics in 2025.

2024-11-26·Blood Advances

Magrolimab plus rituximab with or without chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma

Article

作者: Popplewell, Leslie ; Hacohen-Kleiman, Gal ; Zhang, Yi ; Ghosh, Nilanjan ; Maakaron, Joseph E. ; Asch, Adam ; Roschewski, Mark ; Ku, Matthew ; Mehta, Amitkumar ; Keane, Colm ; Flinn, Ian W. ; Collins, Graham P. ; Advani, Ranjana ; Renard, Camille ; Huo, Yanan ; Smith, Sonali M.

Abstract:

Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) ineligible for available salvage therapies have limited options for long-term disease control, necessitating novel treatments. Previously, magrolimab (anti–cluster-of-differentiation-47 antibody) plus rituximab (M+R) demonstrated ability to induce complete responses (CR) in R/R DLBCL. Here, we report 3-year follow-up data from this phase 1b/2 study assessing long-term safety and efficacy of M+R, and initial safety and efficacy of M+R plus gemcitabine-oxaliplatin (M+R-GemOx), in R/R DLBCL. After magrolimab priming, 4 groups of patients received M+R, 10 to 45 mg/kg magrolimab with 375 mg/m2 rituximab; patients receiving M+R-GemOx received 30 or 45 mg/kg magrolimab with 375 mg/m2 rituximab, 1000 mg/m2 gemcitabine, and 100 mg/m2 oxaliplatin. Primary end points were treatment-emergent adverse events (TEAEs) and objective response rate (ORR). Secondary end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Of 132 patients treated, 99 received M+R and 33 received M+R-GemOx. Most common any-grade TEAEs were fatigue (M+R, 40%; M+R-GemOx, 70%), infusion-related reactions (M+R, 39%), or anemia (M+R-GemOx, 70%). Treatment-related TEAEs led to magrolimab discontinuation in 7% (M+R) and 6% (M+R-GemOx). One death was considered treatment related (M+R-GemOx, colitis). M+R ORR was 24% (CR, 12%), and median DOR was 9.3 months. Median PFS and OS were 1.8 and 9.2 months, respectively. M+R-GemOx ORR was 52% (CR, 39%); 12-month DOR rate was 66.6% (95% confidence interval, 33.1-86.1). Median PFS and OS were 3.9 months and not reached, respectively. These results demonstrate that M+R with/without GemOx is well tolerated, and M+R-GemOx has clinical activity in patients with R/R DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT02953509.

2024-11-26·Blood Advances

Magrolimab plus rituximab in relapsed/refractory indolent non-Hodgkin lymphoma: 3-year follow-up of a phase 1/2 trial

Article

作者: Popplewell, Leslie ; Ghosh, Nilanjan ; Su-Feher, Linda ; Advani, Ranjana ; Bartlett, Nancy L. ; Roschewski, Mark ; Renard, Camille ; Huo, Yanan ; Collins, Graham P. ; Flinn, Ian W. ; Hacohen-Kleiman, Gal ; Smith, Sonali M. ; Mehta, Amitkumar

Abstract:

Relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) is generally considered incurable with current treatment options. Previous phase 1b/2 results showed combining magrolimab (anti–cluster-of-differentiation [CD] 47 antibody) with the anti-CD20 antibody rituximab (M+R) has antitumor activity against R/R iNHL. We report 3-year follow-up data from this phase 1b/2 study assessing long-term safety and efficacy of M+R in R/R iNHL. After magrolimab priming, 4 patient groups in phase 1b M+R received 10 to 45-mg/kg magrolimab doses with 375 mg/m2 rituximab. Phase 2 explored 30 and 45 mg/kg magrolimab. Primary end points were treatment-emergent adverse events (TEAEs) and objective response rate (ORR). Secondary end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Exploratory analysis included circulating tumor DNA, biomarkers of magrolimab tumor penetration, and drug target expression assessments. Of 46 patients treated in phase 1b/2, 42 had follicular lymphoma and 4 had marginal zone lymphoma. All patients experienced ≥1 any-grade TEAE, and 44 reported ≥1 treatment-related TEAE. No additional toxicities were reported during long-term follow-up, and there were no treatment-related deaths. Median follow-up was 36.7 (range, 1.2-62.3) months. The ORR was 52.2%, with 30.4% achieving a complete response. The median DOR was 15.9 months, and median time-to-response was 1.8 months. Median PFS and OS were 7.4 (95% confidence interval, 4.8-13.0) months and not reached, respectively. These results demonstrate the long-term safety and efficacy of M+R in patients with iNHL and support further exploration of CD47-based treatment combinations. This trial was registered at www.ClinicalTrials.gov as #NCT02953509.

224

项与莫洛利单抗相关的新闻（医药）

2025-04-26

·生物制品圈

ALX Oncology 在失败中坚守：CD47 抑制剂的曲折研发路

在生物医药研发领域，失败与希望总是交织在一起。近日，ALX Oncology 公司的核心产品 CD47 抑制剂 evorpacept 在两项中期癌症试验中折戟，这本可能是研发路上的 “休止符”，但公司却选择继续坚守，这一决策引发了行业内外的广泛关注。两项试验失败，研发受挫4 月 25 日，ALX Oncology 公司发布消息称，其 CD47 抑制剂 evorpacept 与默沙东的 Keytruda（帕博利珠单抗）联合使用时，在晚期头颈部鳞状细胞癌患者中未能提高客观缓解率（ORR），未能达到两项 2 期试验的主要终点。这两项试验分别是 Aspen - 03 和 Aspen - 04，前者招募了 189 名患者，将联合用药方案与单独使用 Keytruda 进行对比；后者则招募了 172 名患者，对比联合用药和 Keytruda 加化疗的效果。公司首席医学官艾伦・桑德勒（Alan Sandler）医学博士表示，虽然 Aspen - 03 试验在客观缓解率方面与历史和内部对照相比有一些令人鼓舞的趋势，但公司还是决定不再在头颈部癌领域继续推进 evorpacept 和帕博利珠单抗的联合治疗。他同时表达了对试验结果的失望，尤其是考虑到当前标准治疗方法对部分患者效果不佳，而此次试验未能为这些患者带来新的希望。裁员聚焦研发，仍坚定推进尽管 evorpacept 在这两项试验中失败，但 ALX Oncology 公司并没有放弃这款药物。就在一个多月前，公司为了集中资源推进 evorpacept 的研发，进行了裁员并大幅削减临床前研究。公司首席执行官杰森・莱特曼（Jason Lettmann）表示，基于 evorpacept 此前的积极数据和强大的作用机制，公司对其临床开发项目仍充满信心，并计划在近期通过乳腺癌和结直肠癌的额外临床数据来证明其潜力。ALX Oncology 目前正在开展一系列其他临床试验，测试 evorpacept 与其他疗法联合用于多种癌症的治疗，包括乳腺癌、多发性骨髓瘤和尿路上皮癌等。按照 3 月 5 日发布的计划，公司还打算开展新的试验，分别测试 evorpacept 与曲妥珠单抗联合用于 HER2 阳性乳腺癌，以及与西妥昔单抗联合用于结直肠癌的治疗效果。CD47 研发遇阻，前路充满挑战CD47 受体是细胞膜上的一种蛋白质，癌细胞常利用它来逃避免疫系统的攻击，因此抑制 CD47 受体的活性成为癌症治疗的一个重要研究方向。然而，目前尚无针对 CD47 受体的获批药物，众多药企在该领域的研发都面临着重重困难。此前，吉利德科学（Gilead Sciences）在 2020 年花费 49 亿美元收购了 Forty Seven 公司及其主打资产 ——CD47 抑制抗体 magrolimab 。但经过多年的试验，magrolimab 遭遇了多次失败，还面临 FDA 的临床搁置，甚至出现患者死亡的情况，最终吉利德在 2024 年 8 月彻底放弃了这款药物。ALX Oncology 在 evorpacept 研发上的坚持，无疑是在充满荆棘的道路上继续探索。未来，evorpacept 能否在乳腺癌和结直肠癌等试验中取得突破，为 CD47 抑制剂的研发带来转机，目前还充满未知数。但这家公司的坚守，也让行业看到了生物医药研发的韧性与决心，其后续的研发进展值得持续关注。参考来源：https://www.fiercebiotech.com/biotech/alx-oncology-doubles-down-lead-cd47-inhibitor-after-asset-fails-two-mid-stage-cancer-trials识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

并购临床2期

2025-03-19

·精准药物

Biotech从野蛮生长到理性收缩

作者｜momo 过去十年，Biotech在资本狂欢与技术突破的驱动下，曾以惊人的速度野蛮生长：PD-1单抗扎堆逾百家、TIGIT靶点竞逐、ADC赛道狂热，无数企业涌入同质化赛道，掀起了一场激烈的创新竞赛。然而，当资本退潮、政策趋严、临床试验失败率攀升，Biotech被迫直面“创新效率”的拷问。曾经的“靶点内卷”让位于差异化创新，冗余管线被“精准瘦身”，高风险领域遭遇战略性撤退，标志着行业从“野蛮生长”转向“理性收缩”。 01 中国药企从“烧钱内卷”到“精准狙击” 2024年，国内创新药企掀起一波研发管线终止，折射出行业深层次的结构性挑战。上海医药以近7亿元代价砍掉12项管线，包括因PD-1市场过度竞争而终止的III期宫颈癌药物BCD-100，以及研发进度滞后的类风湿关节炎II期项目I008（图1），这两款药物的累计研发投入分别为5900.80万元和6218.75万元。图1.上海医药终止BCD-100、I008等项目公告数据来源：上海医药官网过去20年间，上海医药累计研发投入超200亿元。高额投入的背后，却是严重不对等的研发成果，上海医药至今只有花费6.9亿元从生诺医药引进的一款抑酸新药信诺拉生酯胶囊（X842）获批上市。 2024年，中国Biotech在资本狂欢褪去后迎来“理性收缩”元年，多家药企掀起研发管线“砍单潮”。天坛生物则因市场情况终止其子公司蓉生药业的“静注巨细胞病毒人免疫球蛋白(ph4)”III期临床试验研究及后续研发。据悉，该公司在这个药物研发上已投入7069.09万元；不谋而合的是，舒泰神也基于新冠市场形势终止了累计研发投入3.83亿元的BDB-001注射液、STSA-1002注射液、STSA-1005注射液等多个项目在COVID-19适应症方向的研究工作。百济神州则战略性终止了与Shoreline Biociences公司的异基因NK细胞疗法合作项目，专注开发自研的细胞治疗产品；类似地，华东医药也放弃疗效逊于HDM1002的口服GLP-1药物TTP273，转向自研潜力产品HDM1002、HDM1005（图2）。图2.华东医药终止TTP273项目公告数据来源：华东医药官网此外，中国Biotech迎来研发寒冬，多家药企因临床试验失败或安全性问题终止核心管线。亚虹医药因APL-1202联合化疗未达主要终点，终止累计投入1.3亿元的核心管线。事实上，亚虹医药已连续多年深陷亏损泥沼，2018年至2023年期间合计净亏损约为15.45亿元；此外，亚宝药业也因II型糖尿病药物SY-004的临床研究未达良好预期而被暂停；宜联生物HER3 ADC（YL202/BNT326）更因临床试验中3例患者死亡遭遇FDA部分叫停，好在已经恢复临床试验。 2024年国内终止项目数量激增，超70%集中在肿瘤及代谢疾病（GLP-1）等同质化赛道，PD-1单抗上市数量远超海外，导致资源严重冗余。中国医药行业正经历从“野蛮生长”到“理性收缩”的阵痛期，企业加速“早期管线止损”，通过聚焦差异化创新重塑竞争力，这场研发寒冬或将成为中国创新药从“量变”到“质变”的分水岭。 02 跨国药企从“广撒网”到“精耕细作” 跨国药企加速研发战略转型，聚焦肿瘤、免疫及神经科学领域高潜力赛道，通过终止或调整临床项目实现资源优化配置，既凸显行业对研发效率的极致追求，亦暴露靶点选择与临床验证的深层风险性。在肿瘤治疗领域，TIGIT靶点研发的集体受挫成为行业焦点。 2023年BMS宣布终止其自研的TIGIT单抗BMS-986207的II期临床试验。同年8月，BMS又退货了Agenus的TIGIT/CD96双抗管线，这意味着其彻底放弃TIGIT靶点；无独有偶，2024年7月，罗氏也终止了TIGIT抗体RG6058的III期临床开发，该产品曾被寄予厚望作为PD-(L)1联合疗法的下一代搭档；图3.罗氏管线调整数据来源：罗氏2024年财报此外，2024年12月，默沙东也因临床数据不足放弃了抗TIGIT抗体vibostolimab的联合疗法开发。这一系列动作使得TIGIT成为继CTLA-4之后又一“折戟沉沙”的免疫检查点靶标，其作用机制和患者筛选标准面临重新审视。与此同时，BMS对肿瘤领域其他靶点药物也展开了大刀阔斧的战略调整。 2024年第二季度，BMS宣布终止CD3/BCMA双抗Alnuctamab的III期开发，尽管该产品在2024年5月刚启动临床试验，但面对再生元Linvoseltamab的上市申请和艾伯维TNB-383B的III期推进，BMS选择战略性退出竞争白热化的BCMA双抗双抗赛道，转而巩固其在CAR-T疗法领域的领先地位。此外，神经退行性疾病领域的高风险性也再次得到验证。罗氏终止了阿尔茨海默病抗Tau单抗bepranemab的开发，这已是该领域近三年内第7个终止的III期项目，凸显β淀粉样蛋白和Tau蛋白假说在临床转化中的困境。阿斯利康则砍掉LOX-1单抗MEDI6570，进一步收缩在脑血管疾病领域的布局。这些调整推动企业将目光转向确定性更高的代谢疾病领域，辉瑞虽因副作用终止GLP-1RA项目洛替列酮，但诺和诺德、礼来在减肥药市场的成功仍吸引着行业持续加码。值得注意的是，在技术平台选择上，ADC和核药成为战略转型的核心方向。吉利德彻底退出CD47赛道，将magrolimab所有研究终止后，转而通过收购扩充肿瘤免疫管线。这种“砍旧立新”的策略在艾伯维身上尤为明显，其在2023年终止了与CytomX Therapeutics关于CX-2029（条件激活CD71 ADC）的合作，并在2024年继续连续终止ABBV-154等3个ADC项目，却在2024年完成对ADC龙头公司的并购，展现“选择性收缩”与“战略性扩张”并行的独特策略。在生物医药创新的新纪元，“少而精”的精准投入正在取代“广撒网”的传统模式，这场静悄悄的革命或将重塑全球制药产业的竞争格局。结语全球Biotech行业正从资本驱动的“野蛮生长”转向科学驱动的“理性收缩”。资本退潮、政策趋严与临床试验失败频发，迫使企业重新审视研发策略，聚焦高潜力赛道与技术平台。这意味着持续深耕差异化创新的企业，终将在行业洗牌中脱颖而出。此外，ADC、双抗、核药等新兴技术平台成为行业转型的核心驱动力，而国际化战略则是企业突破市场瓶颈的必由之路。中国Biotech企业通过出海授权与自建团队加速全球化布局，头部企业如百济神州、信达生物已崭露头角，但中小企业仍需在资金与商业化能力上寻求突破。全球Biotech面对行业分化加剧，短期阵痛不可避免，但长期来看，坚守科学本质与战略定力的企业将赢得未来。无论是跨国巨头还是本土创新者，只有聚焦未被满足的临床需求、开发同类最优药物，才能在“理性收缩”的寒冬中实现从量变到质变的跨越，引领全球Biotech行业迈向新纪元。参考资料 [1]各大企业官网、官微、财报、公告及公开资料声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床3期财报抗体药物偶联物临床2期细胞疗法

2025-02-03

·Business Wire

CD47 Inhibitor Drug Clinical Trials Market Opportunity Outlook 2028: 100+ Drugs In Clinical Trials - Orphan, Fast Track, Breakthrough Therapy Designation Insights - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Global CD47 Inhibitor Drug Clinical Trials Insight & Market Opportunity Outlook 2028" report has been added to ResearchAndMarkets.com's offering. The market for CD47 inhibitors has both opportunities and challenges. Strong commercial interest and encouraging clinical evidence point to substantial development potential. However, there are challenges to address, such managing toxicity profiles, coming up with the best combination plans, and demonstrating distinct therapeutic advantages over current treatments. As the field develops, biomarker development for response prediction and patient selection will probably become more crucial for clinical development as well as marketing tactics. Global CD47 Inhibitor Drug Clinical Trials Insight & Market Opportunity Outlook 2028 Report Highlights Global & Regional Market Opportunity Outlook Insight On More Than 100 CD47 Inhibitor Drugs In Clinical Trials Global CD47 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase Orphan, Fast Track, Breakthrough Therapy Designation Insight Key Drugs Initiation & Completion Year CD47 Clinical Application & Development Outlook By Indication CD47 Inhibitor Drugs Clinical Developments & Trends By Country Global CD47 Inhibitor Drug Market Dynamics Inhibition of the cell surface protein CD47 has emerged as a novel cancer immunotherapy approach that has piqued the interest of both academia and industry in the recent years. Cancer cells often overexpress CD47, which triggers the "don't eat me" signal pathway, thereby helping malignant cells to escape immune surveillance. CD47 inhibitors seek to uncover cancer cells by inhibiting this protein, leaving them open to immune system attack, specifically through increased macrophage phagocytosis. Although no CD47 inhibitor is currently approved for therapeutic usage, the availability of candidates in phase 3 trials suggests that one may be approved in the coming years. With multiple candidates at varying stages of development, the field of CD47 inhibitor research and development is rapidly evolving. Developed by Forty Seven, which is now a part of Gilead, magrolimab is among the most advanced CD47 inhibitors. In early stage clinical trials for hematological tumors, it has demonstrated encouraging outcomes, especially when combined with other cancer treatments. Furthermore, late stage clinical trials evaluating Magrolimab in solid cancer alongside conventional cancer treatments such as docetaxel, Nivolumab, Pembrolizumab, Azacitidine, and Venetoclax are now under progress. Another significant candidate is Evorpacept (ALX148) from ALX Oncology, a high affinity SIRP fusion protein that inhibits CD47. Currently, evorpacept is being assessed as a monotherapy and in combination with widely used anticancer drugs in a number of early phase clinical trials for a variety of solid and hematological tumors. Furthermore, a late-phase trial evaluating Evorpacept in combination with Trastuzumab, Ramucirumab, and Paclitaxel for the treatment of HER2+ gastric cancer is also under progress. A number of other CD47 inhibitors, including as TQB 2928 (Chia Tai Tianqing Pharmaceutical), MP 0621 (Molecular Partners), IMC-002 (ImmuneOncia Therapeutics), and CC 90002 (Celgene), are in the early phases of clinical research. The emphasis on combination therapies is undoubtedly one of the key trends in clinical development. Combining CD47 inhibitors with other immunotherapies, targeted treatments, and chemotherapy is being studied in an effort to overcome resistance mechanisms and provide synergistic benefits. Anticipated growth in the global market for CD47 inhibitors is attributed to the rising cancer incidence and increased use of immunotherapies in the upcoming years. The potential of CD47 inhibitors has been acknowledged by a number of prominent pharmaceutical companies, which has resulted in notable partnerships and acquisitions. The commercial interest in this field is demonstrated by Gilead Science's US$ 4.9 billion acquisition of Forty Seven in 2020 and Pfizer's US$ 2.26 billion acquisition of Trillium Therapeutics in 2021. Although Chinese and American companies presently dominate the market, there is increasing participation from South Korea, Australia, Canada, and Japan. Through clinical research, companies such as Shaperon, InnobationBio, Bitterroot Bio, and ImmuneOncia Therapeutics are making strides with their CD47 inhibitors. The market is becoming increasingly competitive, with several firms striving for market share. Therefore, for commercial success, differentiation based on safety profile, efficacy, and possible combination strategies will be essential. In conclusion, the market for CD47 inhibitors globally is an active rapidly expanding area of cancer immunotherapy. In the years to come, CD47 inhibitors could have a big impact on cancer therapy paradigms because there are several candidates in clinical development and a lot of commercial interest. Key Topics Covered: 1. CD 47 As Novel Cancer Immunotherapy Target 2. Global CD47 Inhibitors Drug Clinical Pipeline Overview 2.1 By Country 2.2 By Company 2.3 By Indication 2.4 By Patient Segment 2.5 By Phase 2.6 By Priority Status 3. CD47 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase 3.1 Research 3.2 Preclinical 3.3 Phase I 3.4 Phase I/II 3.5 Phase II 3.6 Phase II/III 3.7 Phase III 4. Global CD47 Inhibitor Drug Market Opportunity Outlook 4.1 Current Market Overview 4.2 Future Outlook & Opportunities 5. CD47 Clinical Application & Development Outlook by Indication 5.1 Solid Cancers 5.1.1 Breast Cancer 5.1.2 Colorectal Cancer 5.1.3 Lung Cancer 5.1.4 Urogenital Cancer 5.1.5 Gastrointestinal Cancer 5.2 Hematological Malignancies 5.2.1 Lymphoma 5.2.2 Leukemia 5.2.3 Multiple Myeloma 5.2.4 Myelodysplastic Syndrome 5.3 Microbial Infections 6. CD47 Inhibitor Drugs Clinical Developments & Trends By Country 6.1 China 6.2 US 6.3 South Korea 6.4 Australia 6.5 Canada 7. Global CD47 Inhibitors Market Dynamics 7.1 Favorable Parameters 7.2 Market Restraints 8. Competitive Landscape 8.1 Adagene 8.2 ALX Oncology 8.3 ImmuneOncia Therapeutics 8.4 ImmuneOnco Biopharma 8.5 Light Chain Bioscience 8.6 Phanes Therapeutics 8.7 Virtuoso Therapeutics For more information about this report visit https://www.researchandmarkets.com/r/z9gctb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

免疫疗法并购临床研究快速通道临床3期

100 项与莫洛利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11846	-	-	DB16225

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
急性髓性白血病	临床3期	美国	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	日本	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	澳大利亚	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	奥地利	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	比利时	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	加拿大	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	丹麦	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	法国	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	德国	Gilead Sciences, Inc.	2021-07-01
急性髓性白血病	临床3期	中国香港	Gilead Sciences, Inc.	2021-07-01

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临床结果

适应症

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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


NCT04892446 (CTgov)	临床2期	复发性多发性骨髓瘤	36	Daratumumab+Magrolimab (Magrolimab+Daratumumab)	繭衊鏇夢鹽糧窪壓選齋 = 築積齋餘選製鬱築鏇衊積醖艱顧遞夢齋構廠壓 (膚遞壓鑰獵構遞淵獵願, 糧窪繭淵壓壓鬱範淵構 ~ 願衊夢構膚艱鑰艱積醖) 更多	-	2025-05-02
				Magrolimab+pomalidomide+Dexamethasone (Magrolimab+Pomalidomide+Dexamethasone)	繭衊鏇夢鹽糧窪壓選齋 = 鏇鏇窪觸簾鹽獵範鏇廠積醖艱顧遞夢齋構廠壓 (膚遞壓鑰獵構遞淵獵願, 膚鹽築築淵選顧夢醖齋 ~ 鑰製顧醖窪鹽鹽膚壓鑰) 更多
NCT05079230 (ENHANCE-3, CTgov)	临床3期	急性髓性白血病	378	Venetoclax+Magrolimab+Azacitidine (Magrolimab + Venetoclax + Azacitidine)	齋鏇選構蓋衊廠襯積鏇(築簾蓋憲鹹淵壓衊蓋鏇) = 蓋壓窪遞築範窪衊鏇膚構鑰簾範淵鹽構顧鹽廠 (鑰糧糧構顧壓襯廠廠顧, 壓選鬱範獵願鏇範遞構 ~ 範襯膚網窪鑰蓋夢夢築) 更多	-	2025-04-04
				Placebo+Venetoclax+Azacitidine (Magrolimab Matching Placebo + Venetoclax + Azacitidine)	齋鏇選構蓋衊廠襯積鏇(築簾蓋憲鹹淵壓衊蓋鏇) = 網壓鹽鏇範廠選觸鹽簾構鑰簾範淵鹽構顧鹽廠 (鑰糧糧構顧壓襯廠廠顧, 範構壓艱膚鏇淵鏇獵夢 ~ 鏇餘觸廠淵簾淵鏇顧蓋) 更多
NCT04778397 (ENHANCE-2, CTgov)	临床3期	急性髓性白血病	258	Magrolimab+Azacitidine	積構積築夢願糧艱壓簾(遞獵築觸窪糧壓願顧蓋) = 壓窪夢壓鹽積艱餘艱憲網蓋鏇鏇遞繭鹽糧膚獵 (顧餘簾鬱鑰淵願廠艱夢, 廠繭簾觸糧憲醖襯製餘 ~ 餘廠衊簾築醖襯膚廠繭) 更多	-	2025-02-05
ASH2024	N/A	急性髓性白血病	-	Magrolimab in combination with Venetoclax and Azacitidine	蓋鬱觸範廠網鑰觸憲憲(鏇選廠淵積範壓網積選) = Deaths related to pneumonia or lung disease (N=3 vs N=1) and disease progression (N=10 vs N=6) in were increased in the magrolimab arm compared to placebo 壓鏇糧獵願膚鹽壓膚餘 (鑰鑰願襯餘齋憲觸構衊 ) 更多	-	2024-12-08
				Placebo
NCT02953509 (phase 1/2 trial, Pubmed \| Blood Adv) 人工标引	临床1/2期	非霍奇金淋巴瘤	46	Magrolimabrituximab	選齋製蓋壓鹹壓壓築膚(選製範積選糧選齋淵觸) = 鹹網醖鏇鬱鹽觸衊製觸築鬱鹹範衊襯齋膚糧鏇 (膚壓餘築蓋蓋糧鑰膚鬱 ) 更多	积极	2024-11-26
NCT02953509 (Pubmed \| Blood Adv) 人工标引	临床1/2期	弥漫性大B细胞淋巴瘤	132	Magrolimab plrituximabmab	願鏇艱窪遞齋範襯構繭(積鹹繭鏇壓夢齋簾願夢) = 餘衊遞醖夢鑰艱鏇鏇繭襯鑰餘簾壓餘積構鏇鏇 (選鏇觸範憲鹽顧憲繭淵 ) 更多	积极	2024-11-26
				Magrolimab plrituximabmabgemcitabinetaboxaliplatinatin	願鏇艱窪遞齋範襯構繭(積鹹繭鏇壓夢齋簾願夢) = 衊範繭範夢範憲願製鬱襯鑰餘簾壓餘積構鏇鏇 (選鏇觸範憲鹽顧憲繭淵 ) 更多
NCT04827576 (ELEVATE-Lung and UC, SITC2024)	临床2期	转移性非小细胞肺癌 CD47 \| ctDNA	29	Magrolimab plus docetaxel	齋壓鹹觸壓醖憲鏇鏇範(艱遞鹹獵憲構蓋壓積顧) = CD47 expression in pre-treatment biopsies was highly variable, with H-scores ranging from 0 to 300 (median 127.5). Real world data from Tempus Labs, Inc. indicates that high CD47 gene expression is a positive prognostic factor for response to chemotherapy in NSCLC. In our study, longer ORR and PFS was also associated with higher CD47 expression by IHC. Patients with CD47 expression above 50% of tumor cells demonstrated an ORR of 36.4% with corresponding PFS of 8.9 months. 衊夢積餘蓋鏇觸築夢願 (壓鹽衊構憲選膚築鏇衊 )	积极	2024-11-05
NCT04827576 (604, SITC2024)	临床2期	转移性非小细胞肺癌 cluster of differentiation 47 (CD47)	-	Magrolimab + Docetaxel	繭鬱夢網簾鹽窪壓糧膚(鹽觸廠餘蓋蓋觸蓋簾襯) = 鏇醖鬱簾築齋鹹遞醖獵顧製蓋淵糧網繭製鹹壓 (顧選鹹築襯壓夢範範鬱 )	积极	2024-11-05
SOHO2024	N/A	急性髓性白血病	-	Magrolimab in combination with venetoclax and azacitidine	網艱襯憲鏇顧鑰窪憲範(範蓋鹽膚獵廠艱顧艱觸) = 48.3% 鹽願憲築獵襯選獵艱構 (積廠鏇範簾餘遞製製積 ) 更多	-	2024-09-04
				Magrolimab
NCT05079230 (ENHANCE-3, EHA 12024 \| EHA 22024) 人工标引	临床3期	急性髓性白血病一线	378	Magrolimab +Azacitidine + Venetoclax	觸築艱鏇糧衊網網簾鏇(鏇鹹鹽窪選餘鏇壓簾鏇) = 願糧築鏇齋製襯膚艱顧鬱觸憲鹽願壓繭淵艱壓 (夢範衊蓋鹹窪網齋淵淵 ) 更多	不佳	2024-05-14
				Placebo + Azacitidine + Venetoclax	觸築艱鏇糧衊網網簾鏇(鏇鹹鹽窪選餘鏇壓簾鏇) = 襯襯糧糧觸鏇鑰簾簾簾鬱觸憲鹽願壓繭淵艱壓 (夢範衊蓋鹹窪網齋淵淵 ) 更多