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）

2024-10-08

·凯莱英药闻

宜联B7H3 ADC再下一城！携手安进DLL3/CD3双抗达成临床联用合作

欢迎关注凯莱英药闻今日，宜联生物宣布，该公司与安进达成全球临床研究和药品供应合作协议；双方将合作开展靶向B7-H3抗体偶联药物（ADC）YL201与靶向DLL3和CD3的双特异性T细胞衔接蛋白tarlatamab联用的临床试验，用于联合治疗广泛期小细胞肺癌（ES-SCLC）。根据协议条款，安进将主导该试验，宜联生物将为该联合研究提供YL201。关于YL201 YL201是一款靶向B7H3的ADC，基于宜联生物TMALIN®平台所开发；该ADC由一种抗B7H3人单克隆抗体通过蛋白酶可切割连接物与一种新型拓扑异构酶1抑制剂结合。新颖的连接物有效载荷和YL201的位点特异性偶联导致该ADC更亲水，此外，偶联后抗体的结合特异性、亲和力和亲和度均不受影响。临床前研究显示，在耐受良好的剂量下，YL201在细胞系和患者来源的异种移植(CDX和PDX)小鼠模型中都能有效地引起肿瘤消退。猴子体内药代动力学表明，YL201在循环中被认为是“高度稳定的”。安全性评估表明，猴子的安全性可接受，无脱靶毒性。 2023年11月，YL201获得美国食品和药物管理局（FDA）授予的孤儿药资格，用于治疗食管癌（EC）。 2024年9月，宜联生物在2024年欧洲肿瘤内科学会（ESMO）上，公布了YL201的积极临床数据，这是公司首次公布的该药物的临床数据，显示YL201在包括小细胞肺癌、鼻咽癌、野生型非小细胞肺癌在内的多种实体瘤展示出令人鼓舞的抗肿瘤效果。具体来看：截至2024年8月9日，在276例存在至少一次基线后肿瘤评估的患者中，客观缓解率(ORR)为44.6%，疾病控制率(DCR)为83.7%。在广泛期小细胞肺癌（ES-SCLC，n=79）队列中，ORR为68.1%（≥2.0 mg/kg ORR为70.0%），mPFS为6.2个月（≥2.0 mg/kg mPFS为6.2个月）。在脑转移患者中的疗效与整体人群可比，ORR为52.2%，mPFS为5.3个月。在鼻咽癌（NPC，n=75）队列中，ORR为48.6%（≥2.0 mg/kg ORR为48.6%），mPFS为7.2个月（≥2.0 mg/kg mPFS为7.2个月）。在接受过2线及以上标准治疗的患者中，ORR为51.0%，mPFS为7.0个月，与NPC总体人群相当。在驱动基因阴性的非小细胞肺癌（NSCLC，n=68）队列中，在腺癌和淋巴上皮瘤样癌（LELC）亚型中的ORR分别为29.2%和60.9%，mPFS分别为未成熟和8.1个月。在安全性上，312例总体人群中≥G3 TRAE发生率为51%，SAE发生率为28%。最常见的TRAE为血液学毒性，包括白细胞减少症（≥G3 29%）、贫血（≥G3 22%）、中性粒细胞减少症（≥G3 30%）等；非血液学TRAE包括食欲减少（≥G3 1%）、恶心（≥G3 1%）等，间质性肺炎（ILD）仅有3例报道（1.0%）。关于Tarlatamab Tarlatamab（塔拉妥单抗）是一种DLL3×CD3 TCE，已于2024 年5 月获FDA 的加速批准上市，用于治疗广泛期SCLC 患者，成为首款也是唯一一款实体瘤的CD3-BsAbs，可激活患者自身的T 细胞杀伤表达DLL3 的肿瘤细胞。目前，Tarlatamab 在中国处于III 期临床阶段，百济神州拥有中国商业化权益。该药物加速获批主要基于DeLLphi-301临床试验结果，该研究是一项2期临床试验，旨在评估既往接受过治疗的SCLC患者每2周一次静脉注射tarlatamab(10mg/100mg)的抗肿瘤活性和安全性。主要研究终点为盲化独立中心评审（BICR）的客观缓解率（ORR）；次要研究终点为缓解期（DoR）、疾病控制率（DCR）、无进展生存率（PFS）和总生存期（OS），结果显示：（1）10mg组和100mg组的ORR分别为40%、32%；（2）10mg组和100mg组的PFS分别为4.9个月、3.9个月；（3）10mg组的OS为14.3个月，100mg组未达到。 2024 年ELCC年会报道了评估tarlatamab 的长期随访结果，既往治疗过的SCLC 患者所有队列（n=152）的ORR 为25%，中位OS 达17.5 月。其中10mg 组（n=17）的总有效率35.3%，中位OS达20.3 月。II 期临床数据尚未成熟的数据显示，10mg组(n=80）的mOS 为14.3 个月，相对于目前标准二线治疗方案如拓扑替康（中位OS 为6.3 - 7.8 个月）有明显获益。整体安全性表现较好，以10mg 组为例，最常见的AE 是细胞因子释放综合征（51%）、食欲下降（29%）和发热（35%），仅1% 患者发生≥3 级细胞因子释放综合征，3%因TRAE而停用。关于小细胞肺癌依据病理形态学的特征，临床上大致将肺癌划分为非小细胞肺癌（NSCLC）和小细胞肺癌（SCLC）两类，二者分别占85%和15%。SCLC 患者预后差，靶向药研发难度较大。由于SCLC 独特的生物学特性使大多数患者就诊时已出现远处转移，诊断时广泛期占75%；且SCLC 患者预后极差，五年生存率仅7%，其中广泛期SCLC 的五年生存率仅3%。针对小细胞肺癌，目前主要依靠PD-1/PD-L1联合化疗进行治疗。由于SCLC 患者较少出现敏感基因突变，靶向药研发困难，因此长期以来SCLC 的临床研究主要围绕PD-1/PD-L1 抑制剂等泛癌症治疗药物进行。国内外已有多款PD-1/PD-L1 抑制剂获批小细胞肺癌适应症 DLL-3 在SCLC 肿瘤细胞表面特异性高表达，研究表明大约有80%的SCLC 表达DLL-3，而在正常组织中DLL-3表达量较低。随着2024年5月，安进/百济神州的DLL-3/CD3 双抗Tarlatamab获FDA批准上市，其在关键临床中的取得数据与现有疗法相比，疗效提升显著。与此同时，B7-H3 属于B7 家族，参与T细胞活性的调节；更为重要的是，B7-H3 蛋白质在多种正常组织中始终维持在低水平状态，但却在肺癌、胃癌、肾癌等多种原发实体瘤中存在高表达；在SCLC 患者中，约65%的SCLC 患者为 B7-H3 过表达。B7-H3 蛋白的分布特点使其成为有吸引力的肿瘤药物研发的靶点，但目前尚无疗法获批。 B7H3靶点的研发却并非一番风顺；从2019年CD3/B7H3双抗MGD009的Ⅰ期临床试验出现肝脏毒性被FDA叫停，到2022年B7H3单抗MGA271在II期临床试验中因遭遇重大挫折而宣布停止，再到RDC药物131I-omburtamab因试验未达中位OS而被16:0反对上市等等，众多研究在B7H3靶点上接连翻车。目前来看，B7H3 ADC成为最有潜力跑赢的研发管线。 B7H3 ADC的在研管线具体来看，第一三共的DS-7300a是目前首个推进到临床III期阶段的B7H3 ADC，翰森制药的HS-20093也紧随其后，YL201与二者对比数据如下图所示：在经治SCLC中，采用tarlatamab 和B7H3 ADC联用策略，是一种十分具有前景的治疗手段。关于宜联生物宜联生物成立于2020年7月8日，是一家专注于抗体药物结合物（ADC）和相关技术的创新药物开发公司。公司已开发出最新一代具有自主知识产权的Tumor Microenvironment Activable LINker-payload（TMALIN®）新型抗体偶联药平台技术，可利用肿瘤微环境和传统溶酶体在胞外胞内实现双重裂解机制、兼具高水溶性、高均一性、高体内外稳定性以及肿瘤组织富集特性。具体表现为：独特的酶消化特性，具有在肿瘤微环境中细胞外溶解的能力，无论抗体是否具有内吞能力，所形成的ADC仍具有较高的抗肿瘤活性，大大拓宽了抗体的选择范围；这种特殊的结构使ADC能够丰富肿瘤微环境，增加肿瘤中有效载荷的比例和血液浓度，并具有较高的治疗指数；酶消化特性和肿瘤富集特性使有效载荷在肿瘤组织中大大富集，产生较强的旁观者效应，在抗原表达低甚至无抗原表达的肿瘤中产生良好的抗肿瘤作用。此外，TMALIN技术形成的ADC具有许多优点，已在多个体内药效模型与大动物毒理评价实验中，展现出相比于现有ADC技术更宽的药物治疗窗。具体优势包括：它具有极高的全身循环稳定性，可减少有效载荷在非靶组织中的脱落以及有效载荷在无靶组织中脱落所引起的“偏离靶”毒性。它具有优异的溶解性和优异的化学稳定性，不存在传统ADC中马来酰亚胺连接方式引起的可逆Michael加成反应，可以获得高均匀度的ADC（DAR=8.0），并实现定点定量耦合。耦合效率高(≥90%）。目前，公司已有多款基于该平台的ADC产品进入临床试验阶段。参考资料 1、各公司官网 2、国金证券 3、猎药人俱乐部感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

临床结果抗体药物偶联物孤儿药

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

2024-04-25

·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

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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	窪範願願鏇構遞鑰膚襯(廠願獵醖醖憲襯範窪鹹) = 網繭蓋齋積繭夢襯製網鹽鹽齋願醖構蓋鬱夢衊 (餘鏇衊醖選選鑰餘鹹壓, 遞範遞獵襯醖襯範顧簾 ~ 構構繭鏇膚築醖窪膚夢) 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	願夢壓鑰廠獵觸鑰醖淵(窪餘鑰遞窪繭製積網製) = 繭範艱膚衊膚製蓋夢鹽衊夢願憲鹽構憲壓積淵 (觸鑰廠構壓憲齋夢鹹淵, 61 ~ 85) 更多	积极	2022-12-08
NCT00089245 (Pubmed) 人工标引	临床1期	肿瘤	38	131I-Omburtamab	選願製夢艱夢願餘築願(鏇獵遞醖壓壓選艱願鑰) = Grade 3/4 thrombocytopenia was the most common hematologic toxicity 鹽築壓夢鹹齋淵衊鹽糧 (鹹齋遞壓鹹觸遞憲願齋 ) 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	積蓋構艱蓋廠廠餘顧構(餘遞廠衊顧獵繭壓鏇餘) = 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) 餘觸膚繭積鏇醖獵積醖 (醖鑰獵製積選窪繭憲襯 )	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	選鬱觸廠鏇構鹽獵構衊(壓範構艱糧餘蓋構願鏇) = 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 獵夢糧網網製網選鏇範 (襯獵鬱觸廠構顧製餘鏇 )	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	餘築鹹鹹淵淵顧觸蓋積(選築餘壓窪夢範積蓋淵) = 鹹獵淵選膚製觸獵鑰餘蓋壓製鑰獵積膚鹽鑰憲 (願遞鏇遞選構鹹構願膚 )	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	遞齋餘艱齋鹽醖夢糧簾(觸膚窪選齋範淵夢膚願) = chemical meningitis (n = 2),and increasing communicating hydrocephalus (n = 1) 觸鹹構鏇艱簾襯鬱鹹築 (鬱鹽網蓋淵齋廠鏇鹽遞 )	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	膚選網醖觸襯衊鬱積鑰(網願顧鹽餘廠窪鹽觸鬱) = 廠壓選壓積鏇廠構齋製選餘壓夢膚獵醖壓襯簾 (夢膚夢遞膚積鏇齋淵顧 ) 更多	积极	2017-06-04
ASCO2007	N/A	脑膜癌病	37	Salvage regimen with RIT	憲廠簾廠膚壓網鑰憲鹹(構獵襯鹹繭積憲簾餘艱) = 醖繭遞築衊範繭範齋積窪餘窪蓋憲範壓夢廠衊 (壓鹹艱鏇獵憲鏇積網膚 )	积极	2007-06-20
ASCO2007	N/A	脑膜癌病	37	Combination of surgery, chemotherapy, and radiation	憲廠簾廠膚壓網鑰憲鹹(構獵襯鹹繭積憲簾餘艱) = 窪鹽觸壓積壓糧齋網獵窪餘窪蓋憲範壓夢廠衊 (壓鹹艱鏇獵憲鏇積網膚 )	积极	2007-06-20