A Phase 2 study investigating the addition of cRIT 131I-omburtamab to irinotecan, temozolomide, and bevacizumab for patients with recurrent medulloblastoma. A feasibility cohort is included to assess the feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma.
Direct intraventricular delivery of radiolabeled tumor-specific antibodies may aid in both the detection and treatment of recurrent disease for these highly specific pediatric patients with recurrent tumors.

开始日期2022-04-04

申办/合作机构

Y-mAbs Therapeutics, Inc.

[+2]

NCT05063357

/ Withdrawn临床1期

Safety of 131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma Previously Treated With External Beam Radiation Therapy

Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7- H3). Omburtamab is 131I-labeled at designated radio pharmacies and will be provided as a final radiolabeled product to treatment site. The proposed intervention includes surgical placement using standard stereotactic techniques of a small caliber cannula into the tumor in the pons followed by positive pressure infusion (i.e. CED) of 131I-omburtamab. Iodine-131 conjugated omburtamab (131I-omburtamab) administered via the intracerebroventricular route for the treatment of metastatic CNS neuroblastoma was shown to be tolerable and improve survival. Furthermore, 124I-omburtamab administered by convection enhanced delivery (CED) was shown to have a tolerable safety profile in an ongoing dose escalation trial (in doses up to 4mCi) in patients with diffuse pontine gliomas that have not progressed following external beam radiation therapy. The aim of this trial is to determine the efficacy and safety of 131I-omburtamab in patients with DIPG that have not progressed following external beam radiation therapy.

开始日期2022-03-01

申办/合作机构

Y-mAbs Therapeutics, Inc.

[+2]

JPRN-jRCT2021200024

/ Not yet recruiting临床2/3期IIT

A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-omburtamab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases.

开始日期2021-05-26

申办/合作机构-

100 项与 131I-Omburtamab 相关的临床结果

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100 项与 131I-Omburtamab 相关的转化医学

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100 项与 131I-Omburtamab 相关的专利（医药）

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项与 131I-Omburtamab 相关的文献（医药）

2024-02-01·Journal of immunotherapy and precision oncology

B7-H3 Inhibitors in Oncology Clinical Trials: A Review

Review

作者: Martin, Jared ; Falchook, Gerald S. ; Feustel, Kavanya

ABSTRACT:

B7-H3 is a transmembrane receptor highly prevalent on malignant cells and plays an important role in adaptive immunity that is not fully elucidated. Targeted B7-H3 inhibitors, including antibody-drug conjugates, radioimmunotherapy, and monoclonal antibodies, are a new class of antineoplastic agents showing promising preliminary clinical efficacy, observed with several of these agents against multiple tumor types. Particularly promising treatments are enoblituzumab for prostate cancer, 131I-omburtamab for central nervous system malignancies, and HS-20093 for small-cell lung cancer but further studies are warranted. There are clinical trials on the horizon that have not yet enrolled patients examining chimeric antigen receptor T-cell therapies, bi- and tri-specific killer engagers, and dual-affinity retargeting proteins. These data will be telling of the efficacy of B7-H3 inhibitors in both hematologic and solid malignancies. This study aimed to compile available results of B7-H3 inhibitors in oncology clinical trials.

2023-06-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Radioimmunoscintigraphy and Pretreatment Dosimetry of¹³¹I-Omburtamab for Planning Treatment of Leptomeningeal Disease

Article

作者: Pandit-Taskar, Neeta ; Zanzonico, Pat B ; Pentlow, Keith S ; Humm, John L ; Modak, Shakeel ; Kramer, Kim ; Grkovski, Milan

Radiolabeled antibody treatment with ¹³¹I-omburtamab, administered intraventricularly into the cerebrospinal fluid (CSF) space, can deliver therapeutic absorbed doses to sites of leptomeningeal disease. Assessment of distribution and radiation dosimetry is a key element in optimizing such treatments. Using a theranostic approach, we performed pretreatment ¹³¹I-omburtamab imaging and dosimetric analysis in patients before therapy. Methods: Whole-body planar images were acquired 3 ± 1, 23 ± 2, and 47 ± 2 h after intracranioventricular administration of 75 ± 5 MBq of ¹³¹I-omburtamab via an Ommaya reservoir. Multiple blood samples were also obtained for kinetic analysis. Separate regions of interest (ROIs) were manually drawn to include the lateral ventricles, entire spinal canal CSF space, and over the whole body. Count data in the ROIs were corrected for background and physical decay, converted to activity, and subsequently fitted to an exponential clearance function. The radiation absorbed dose was estimated to the CSF, separately to the spinal column and ventricles, and to the whole body and blood. Biodistribution of the injected radiolabeled antibody was assessed for all patients. Results: Ninety-five patients were included in the analysis. Biodistribution showed prompt localization in the ventricles and spinal CSF space with low systemic distribution, noted primarily as hepatic, renal, and bladder activity after the first day. Using ROI analysis, the effective half-lives were 13 ± 11 h (range, 5-75 h) for CSF in the spinal column, 8 ± 3 h (range, 3-17 h) for ventricles, and 41 ± 11 (range, 23-81 h) for the whole body. Mean absorbed doses were 0.63 ± 0.38 cGy/MBq (range, 0.24-2.25 cGy/MBq) for CSF in the spinal column, 1.03 ± 0.69 cGy/MBq (range, 0.27-5.15 cGy/MBq) for the ventricular CSF, and 0.45 ± 0.32 mGy/MBq (range, 0.05-1.43 mGy/MBq) for the whole body. Conclusion: Pretherapeutic imaging with ¹³¹I-omburtamab allows assessment of biodistribution and dosimetry before the administration of therapeutic activity. Absorbed doses to the CSF compartments and whole body derived from the widely applicable serial ¹³¹I-omburtamab planar images had acceptable agreement with previously reported data determined from serial ¹²⁴I-omburtamab PET scans.

2023-04-01·Pediatric blood & cancer

Multimodality treatment for recurrent neuroblastoma in the central nervous system

Article

作者: Cohn, Susan L. ; Elmuti, Lena ; De Guzman, Raymond M. ; Streby, Keri A. ; Cahaney, Christine ; Desai, Ami V.

Abstract:

Survival for patients with recurrent central nervous system (CNS) neuroblastoma remains poor. A single‐institutional study demonstrated the potential of multimodality therapy, including compartmental intrathecal radioimmunotherapy (cRIT) with 131I‐3F8 or 131I‐8H9 to increase the survival of neuroblastoma patients with CNS relapse. However, not all patients are able to receive this therapy. We report three patients with CNS neuroblastoma who remain disease‐free 3–9 years after receiving multimodality treatment without cRIT. Additional studies to identify patients most likely to benefit from cRIT are warranted.

项与 131I-Omburtamab 相关的新闻（医药）

2024-06-07

·BioSpace

Y-mAbs Announces Preclinical GD2-SADA Data to be Presented at 2024 SNMMI Annual Meeting

NEW YORK, June 07, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that preclinical GD2-SADA data will be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8 – 11, 2024, in Toronto, Canada. The poster titled “High-affinity and specific binding between DOTA-chelated lanthanides and GD2-SADA, a self-assembling and disassembling bispecific fusion protein for pre-targeted” (poster #241436) characterizes the binding properties of GD2-SADA, a Self-Assembling and DisAssembling (“SADA”) bispecific fusion protein used in a two-step approach to pre-targeted radioimmunotherapy (“PRIT”). Building on previous studies, the analysis demonstrates real-time, high-affinity binding interactions between the GD2-SADA protein and several “caged” lanthanide metals with diagnostic and therapeutic applications. “The results reinforce the potential clinical utility of GD2-SADA in the diagnosis and treatment of GD2-expressing tumors, and the strength of our radiochemistry program,” said Johannes Nagel, Ph.D., lead author. “Based on the totality of our preclinical data, we are continuing to advance our GD2-SADA program through Phase 1 clinical development.” Researchers at Memorial Sloan Kettering Cancer Center (“MSK”), including Dr. Nai-Kong V. Cheung, M.D., Ph.D., developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and in Y-mAbs. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy, and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. About GD2-SADA PRIT GD2-SADA is a bispecific fusion protein that tightly binds to the glycolipid GD2 and Lutetium 177 (Lu 177)-DOTA, a chelated or “caged” radionuclide. In the first step of pre-targeted radiotherapy, non-radiolabeled GD2-SADA tetramers are infused and bind to GD2-expressing solid tumors, while unbound GD2-SADA protein disassembles into low molecular weight monomers that are removed by the kidney. The second infusion delivers the “radioactive payload,” which binds directly to GD2-SADA on tumor cells for localized irradiation. GD2-SADA PRIT with Lutetium 177-DOTA is currently being investigated in adults and adolescents in Trial 1001 (NCT05130255). Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2024 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans, including potential partnerships; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to DANYELZA as a growing commercial product and SADA as a differentiated radioimmunotherapy platform positioning the Company on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients’ lives; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA Technology, including potential indications and applications, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company’s future financial performance; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’, “guidance,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. DANYELZA®, OMBLASTYS® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact: Courtney Dugan VP, Head of Investor Relations cdu@ymabs.com

免疫疗法引进/卖出上市批准

2024-05-11

·药时代

5例患者死亡，股价大跌77%！B7H3 ADC再生事端

正文共：2491字 7图预计阅读时间：6分钟ADC的火热无需赘言，辉瑞430亿美元买下Seagen，国内药企2023年相关资产出海十余笔。但在新药研发领域，却是冰与火共存，黑天鹅与灰犀牛横行的复杂光景。美东时间9月5日，MacroGenics公布B7H3 ADC vobra duo（原MGC018）最新临床进展。在其用于治疗转移性去势抵抗性前列腺癌（mCRPC）患者的II 期 TAMARACK研究中，出现5例死亡事件，MacroGenics股价应声大跌77%，收盘价为3.31美元/股。在这5起死亡病例中，有2人被MacroGenics判为与vobra duo无关，1人死于急性心肌梗死，另1人死于心脏骤停。其余病例死因则为肺炎（2人）和3级胸腔积液，是否与vobra duo相关，需等待进一步调查结果。I期试验中，就出现了患者死亡vobra duo是一款以人源化B7H3单抗为靶头、缬氨酸-瓜氨酸（vc）为可裂解连接子、前药seco-DUBA为载荷的ADC药物，DAR值约为2.7。早在其I期研究中，就因不良事件导致了高比例的剂量调整和治疗提前终止。该研究共纳入40名mCRPC、21名NSCLC、16名三阴乳腺癌和9名黑色素瘤患者。86名患者中有78 名（91%）至少经历了一次任何级别的TRAE；有43名（50%）经历了≥3级TRAE；以及两起死亡病例：一起原因不明，另一起由SARS-CoV-2引起。不过好在vobra duo作为单药在治疗mCRPC患者时，显示出了不错的抗肿瘤活性。其（3mg/kg，Q3W）剂量组的ORR达25%（4/16），PSA水平降低50%以上的患者比例为54%（21/39）。故，只要降低起始剂量，改善耐受性，延长治疗时间，vobra duo在mCRPC中理应有良好的治疗前景。TAMARACK研究采用的便是接近（3mg/kg，Q3W）剂量的（2.0mg/kg，Q4W）与（2.7mg/kg，Q4W）两个剂量组。患者死亡时间为近5个月值得注意的是，2024年4月3日，MacroGenics刚公布了该试验的中期安全性数据，但并未报患者死亡，数据截止日期为2024年1月4日。也就是说，5起死亡病例接连发生在近5个月内。据统计，TAMARACK研究中共有182名mCRPC患者入组，其中177名接受了vobra duo治疗。入组患者的年龄在46至89岁之间（中位数70.5岁），ECOG评分≤2。截止2024年1月4日前，无论剂量如何，治疗期间最常见的（≥10%）TEAE，包括虚弱（40.7%）、恶心（27.7%）、疲劳（20.3%）等不良反应。在接受治疗≥12周或在12周内停止研究治疗的TAMARACK患者子集（n = 95）中，TEAE导致了12名（12.6%）患者药物中断和5名（5.3%）患者停药。这要比I期研究中3mg/kg剂量组，在12周时观察到的药物中断率（58.5%）和停药率（14.6%）更为有利。而如今5位患者死亡，2.0mg/kg剂量组1例，2.7mg/kg剂量组4例，三级及以上不良事件发生率较日前大幅增加。反观疗效方面，两剂量组中PSA下降超过50%的患者双双过半。同时，缓解效果也较为明显，ORR分别为24.4%、43.8%（2.7mg/kg），DCR分别为91.1%（2.0mg/kg）、87.5%。借于此，MacroGenics想要继续拓展vobra duo的研发，计划2024年中在TAMARACK研究中增加NSCLC、SCLC、黑色素瘤等患者，并探索与PD-1/CTLA-4双抗Lorigerlimab（MacroGenics/吉利德）联用的可及性。不过在此之前，还需要先明确另外三起死亡病例是否与药物相关，以及FDA介入后的态度。研发之路虽坎坷，但火热目前，尚无B7H3靶向药物获批上市，原本进展最快的是Y-Mabs/赛生药业的omburtamab（一种放射性核素碘131标记的靶向B7H3单克隆抗体），后因试验设计问题于2022年遭FDA拒批。同年，MacroGenics终止了其B7H3×CD3双特异性抗体的开发。至于B7H3单抗，MacroGenics也“受过伤”，旗下Enoblituzumab（天境生物拥有大中华区权益），在一项治疗头颈部鳞状细胞癌的II期临床试验中，出现7名患者死亡，该试验后被停止。即便多次受挫，MacroGenics的在研管线中还有三款B7H3资产：2款B7H3 ADC（vobra duo、MGC026），以及一款B7H3单抗Enoblituzumab。以小见大，B7H3的研发之路虽坎坷，但火热。当MacroGenics仍在平衡疗效与安全性之时，第一三共的B7H3 ADC已经率先进入临床III期，并在小细胞肺癌等适应症取得了优异的疗效数据；翰森制药的B7H3 ADC于去年以17.1亿美元的交易总价成功出海GSK；宜联生物、迈威生物、信达生物等众多本土药企均在B7H3领域紧追不舍……避无可避ADC的大部分毒性由连接子-有效载荷复合物决定，即便采用了相同的有效载荷和连接子，也会因抗体靶向性、非肿瘤毒性，可能出现截然不同的副作用或非预期反应。而特定靶标的参与或有效载荷在表达ADC靶标的非恶性组织中的积累，可能是此次患者死亡的原因之一。（即毒素的蓄积导致毒性的出现）说回MacroGenics，当初选择差异化开发前列腺癌适应症，便是为了规避锋芒，如今安全性再次生疑，vobra duo的前景逐渐变得扑朔迷离。是继续鉴于其疗效的初步优效性，另辟蹊径；还是回到NSCLC等大适应症中，与第一三共等药企“硬刚”，药时代将持续关注。参考资料：1.MacroGenics官网2.雪球3其他公开资料封面图来源：pixabay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.cnFDA主任Peter Marks：把基因疗法的价格打下来！11个月婴儿恢复听力，再生元、礼来均有布局，国内药企领跑CAR-T疗法新突破：一名15岁少女的重生点击阅读原文，了解更多！

临床结果抗体药物偶联物临床2期临床1期

2024-04-25

·GlobeNewswire-Health Care

Y-mAbs to Present at 2024 ASCO Annual Meeting

NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the acceptance of four abstracts at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL. “This year’s ASCO presentations feature our ongoing efforts to grow and diversify our portfolio,” said Mike Rossi, President and Chief Executive Officer. "From our investigational SADA PRIT Technology Platform to our approved therapy, DANYELZA® (naxitamab-gqgk), for relapsed or refractory high-risk neuroblastoma, we look forward to demonstrating the many ways in which we are expanding and refining the promise of next-generation radioimmunotherapy and antibody-based therapies to improve patient lives." The following abstract will present data on the Company’s investigational Self-Assembly DisAssembly (“SADA™”) Pretargeted Radioimmunotherapy (“PRIT™”) platform: Abstract Title: Preclinical characterization of pretargeted radioimmunotherapy (PRIT) with GD2-SADA, a self-assembling and disassembling bispecific fusion proteinFormat: Abstract Publication The following abstracts will present data on DANYELZA® (naxitamab-gqgk), the Company's approved therapy for the treatment of pediatric patients with relapsed or refractory high-risk neuroblastoma, which is currently also being evaluated for the treatment of osteosarcoma and other GD2-positive tumors: Abstract Title: Patterns of improvement following initial response in patients treated with naxitamab for relapsed/refractory high-risk neuroblastomaPoster Number: #10033Format: Poster Presentation Abstract Title: Naxitamab-related adverse events within and across treatment cycles in patients with relapsed/refractory (R/R) high-risk neuroblastomaPoster Number: #10032Format: Poster PresentationAbstract Title: Naxitamab chemo-immunotherapy regimens other than with irinotecan/temozolomide for patients with relapsed/refractory high-risk neuroblastomaPoster Number: #10037 (Independent Research)Format: Poster Presentation Y-mAbs will be available for comment at booth #35151 on the Exhibition Floor of McCormick Place. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and Y-mAbs. Researchers at MSK, including Dr. Nai-Kong Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology. About DANYELZA® (naxitamab-gqgk)DANYELZA® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2023 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans, including potential partnerships; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to DANYELZA as a growing commercial product and SADA as a differentiated radioimmunotherapy platform positioning the Company on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients’ lives; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA Technology, including potential indications and applications, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company’s future financial performance; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’, “guidance,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. DANYELZA®, OMBLASTYS® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact:Courtney DuganVP, Head of Investor Relationscdu@ymabs.com

免疫疗法引进/卖出上市批准ASCO会议临床研究

100 项与 131I-Omburtamab 相关的药物交易

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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
神经母细胞瘤	申请上市	欧盟	Y-mAbs Therapeutics, Inc.	2022-12-15
中枢神经系统肿瘤	临床3期	美国	Y-mAbs Therapeutics, Inc.	2018-12-11
脑膜白血病	临床3期	美国	Y-mAbs Therapeutics, Inc.	2018-12-11
脑膜白血病	临床3期	日本	Y-mAbs Therapeutics, Inc.	2018-12-11
脑膜白血病	临床3期	丹麦	Y-mAbs Therapeutics, Inc.	2018-12-11
脑膜白血病	临床3期	西班牙	Y-mAbs Therapeutics, Inc.	2018-12-11
肿瘤转移	临床3期	美国	Y-mAbs Therapeutics, Inc.	2018-12-11
肿瘤转移	临床3期	日本	Y-mAbs Therapeutics, Inc.	2018-12-11
肿瘤转移	临床3期	丹麦	Y-mAbs Therapeutics, Inc.	2018-12-11
肿瘤转移	临床3期	西班牙	Y-mAbs Therapeutics, Inc.	2018-12-11

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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


NCT03275402 (101, CTgov)	临床2/3期	脑膜白血病 \| 肿瘤转移 \| 神经母细胞瘤	52	131I-omburtamab	窪襯鬱獵艱獵簾糧膚夢 = 願艱觸鹹齋醖鹹蓋鹹糧構糧鑰範範夢廠繭鑰鹹 (膚繭鏇網觸簾餘艱夢艱, 鹽膚蓋餘築憲獵築築選 ~ 選廠簾蓋獵鹹繭鏇糧餘) 更多	-	2024-02-13
NCT03275402 (101, ESMO_IO2022) 人工标引	临床2/3期	神经母细胞瘤	50	131I-Omburtamab	獵構製齋選遞鑰簾窪觸(鏇醖憲蓋餘壓鏇艱醖構) = 蓋糧獵獵壓齋餘積艱積醖遞觸窪淵簾顧遞餘壓 (鑰顧糧築範網鏇願鹹築, 61 ~ 85) 更多	积极	2022-12-08
NCT00089245 (Pubmed) 人工标引	临床1期	肿瘤	38	131I-Omburtamab	積築鏇艱遞鬱鹽觸選醖(範襯網蓋遞窪餘遞衊艱) = Grade 3/4 thrombocytopenia was the most common hematologic toxicity 鬱膚醖淵鑰選餘壓鏇繭 (襯鏇築蓋艱襯願齋積齋 ) 更多	积极	2022-11-12
NCT01502917 (MSKCC 11-011, ASCO 12021 \| ASCO 22021) 人工标引	临床1期	弥漫内生性脑桥神经胶质瘤	46	124I-omburtamab	憲衊觸範製壓網蓋糧廠(齋簾築憲衊壓壓窪繭蓋) = Eight patients have reported transient AEs of grade 3 considered related to 124I-omburtamab. The acute grade 3 AEs were generally indicative of nervous system effects due to volume intolerance or radiation injury, and included hemiparesis (n = 3), dysarthria (n = 3), ataxia (n = 3), dysphagia (n = 2), muscular weakness (n = 2) and gait disturbance (n = 1) 鬱壓網鹹鏇網憲憲醖淵 (製膚衊膚製簾鏇積淵夢 )	积极	2021-05-28
NCT01099644 (Pubmed \| J Urol \| J Clin Oncol) 人工标引	临床1期	促纤维增生性小圆细胞瘤 \| 腹膜癌	52	131I-Omburtamab	糧鏇襯廠鑰壓製選鬱衊(構選廠願鬱鏇夢夢鏇憲) = grade 4 neutropenia (n = 2 patients) and thrombocytopenia (n = 1), and grade 1 (10%) and grade 2 (52%) pain lasting < 2 hours related to saline infusion. Hypothyroidism was not observed 簾糧築餘壓醖餘觸壓壓 (築衊鹹醖蓋艱糧遞壓餘 )	积极	2020-12-20
NCT03275402 (Corporate Publications) 人工标引	临床2/3期	神经母细胞瘤	17	Omburtamab	壓遞淵艱顧廠艱襯鹽壓(遞壓膚淵遞膚築壓鏇選) = 鑰糧夢簾選膚餘蓋願構襯構艱醖獵餘壓壓醖遞 (製鏇願餘醖艱壓構憲醖 )	积极	2020-10-16
NCT00089245 (ASCO 12019 \| ASCO 22019) 人工标引	临床1期	中枢神经系统肿瘤	57	131I-8H9	壓蓋築獵鏇積襯範獵範(鬱壓獵顧鏇鹹願襯淵鑰) = chemical meningitis (n = 2),and increasing communicating hydrocephalus (n = 1) 壓選襯顧餘繭淵鬱衊衊 (選範齋築淵窪簾壓艱蓋 )	积极	2019-05-31
NCT00089245 (ASCO2017) 人工标引	临床1期	神经母细胞瘤	105	131I-8H9 cRIT±systemic immunotherapy	構淵範鹹範鏇膚鹽鬱淵(顧積衊繭襯鏇願鹽積鏇) = 簾築選鏇遞憲襯夢衊艱鹹襯糧築鹹積廠衊蓋遞 (餘鹽鬱顧餘醖製鬱鬱顧 ) 更多	积极	2017-06-04
ASCO2007	N/A	脑膜癌病	37	Salvage regimen with RIT	網夢積艱製壓製顧鬱衊(襯餘顧鑰鹽艱鏇獵蓋淵) = 遞餘獵觸獵構膚觸齋範簾願築顧範醖廠壓築蓋 (顧壓構夢遞蓋選構築餘 )	积极	2007-06-20
ASCO2007	N/A	脑膜癌病	37	Combination of surgery, chemotherapy, and radiation	網夢積艱製壓製顧鬱衊(襯餘顧鑰鹽艱鏇獵蓋淵) = 夢夢鹹淵觸襯獵築壓構簾願築顧範醖廠壓築蓋 (顧壓構夢遞蓋選構築餘 )	积极	2007-06-20