The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for 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, it may not be approved in the type of disease used in this study.
The goals of this part of the study are:
* Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer
* To determine the activity of study treatments chosen based on:
* How each subject responds to the study treatment
* How long a subject lives without their disease returning/progressing

Start Date01 Nov 2024

Sponsor / Collaborator

Hershey Medical Center

NCT06528496 / RecruitingPhase 2IIT

N10: Reduced Therapy for High-Risk Neuroblastoma

The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

Start Date22 Jul 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

NCT06574698 / RecruitingNot ApplicableIIT

Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma: A Prospective, Single-Arm Clinical Study

To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.

Start Date06 May 2024

Sponsor / Collaborator

Guangzhou Women & Childrens Medical Center

100 Clinical Results associated with Naxitamab

100 Translational Medicine associated with Naxitamab

100 Patents (Medical) associated with Naxitamab

155

Literatures (Medical) associated with Naxitamab

01 Nov 2024·Cancer Genomics & Proteomics

GD2 in Breast Cancer: A Potential Biomarker and Therapeutic Target

Review

Author: Mokbel, Kefah ; MOKBEL, KEFAH

Expression of disialoganglioside GD2 in normal tissues is primarily limited to the central nervous system, peripheral sensory nerve fibers, dermal melanocytes, lymphocytes, and mesenchymal stem cells. Its widespread overexpression in various cancer types allows it to be classified as a tumor-associated antigen with potential diagnostic and therapeutic implications. This article reviews the synthesis pathways of GD2 and its role in cancer cell adhesion, proliferation, and metastasis with a focus on breast cancer. GD2 appears to be overexpressed on the outer membrane of most breast cancer cells and breast cancer stem cells (BCSCs) and is closely linked to epithelial-mesenchymal transition (EMT). GD3 synthase (GD3S) is considered to be the rate-determining step in GD2 synthesis. Clinical studies indicate that GD2 expression is increased in 35-70% of breast cancer samples, with higher levels in triple-negative breast cancer (TNBC). This overexpression correlates with more aggressive tumor features and worse prognosis. Therapeutic targeting of GD2 with monoclonal antibodies (moABs) like dinutuximab and naxitamab has demonstrated anti-cancer activity in preclinical cancer models and human clinical trials against high-risk neuroblastoma reducing tumor growth and enhancing survival. GD2-specific chimeric antigen receptor (CAR) T-cell therapy and GD3S inhibition present other promising therapeutic strategies to improve clinical outcomes. Furthermore, GD2-targeted vaccines are currently being investigated in cancer therapy. This narrative review article underscores the critical role of GD2 in breast cancer pathogenesis and highlights the promising therapeutic opportunities it offers. It advocates for the initiation of clinical trials to further explore the potential of GD2-targeted treatment in combination with standard breast cancer therapies.

01 Oct 2024·JOURNAL OF PEDIATRIC HEMATOLOGY ONCOLOGY

Omalizumab for Treatment of Anti-GD2 Antibody-related Urticaria

Article

Author: Lentini-Rivera, Angela ; Lin, Yichih ; Shrager, Leslie ; Kasper, Christine ; Markova, Alina ; Andre Jones, Latisha ; Modak, Shakeel ; Lacouture, Mario ; Durney, Christina ; D’Andrea, Linda ; Glincher, Rachel

Outcomes for high-risk neuroblastoma have improved with the addition of antidisialoganglioside (GD2) antibody-mediated immunotherapy to multimodality therapy. Urticaria is an expected side effect of anti-GD2 immunotherapy. Rarely, despite maximal use of antihistamines and H2 receptor antagonists, refractory urticaria can result in impaired quality of life, and delays or discontinuation of immunotherapy. The anti-IgE monoclonal antibody, omalizumab, is approved for the treatment of asthma and chronic spontaneous urticaria. We successfully managed grade 3, naxitamab-related urticaria refractory to standard management in 2 patients using omalizumab, allowing for continued anti-GD2 immunotherapy. Omalizumab did not impact antitumor activity or immunogenicity of naxitamab.

01 May 2024·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Verma, Sant Kumar ; Navneesh, N ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

News (Medical) associated with Naxitamab

25 Oct 2024

·www.biospace.com

Y-mAbs Announces Third Quarter 2024 Conference Call and Webcast

NEW YORK, Oct. 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 it will report third quarter 2024 financial and operating results before the market open on Friday, November 8, 2024. The Company will hold a conference call and webcast to discuss these results at 8:00 a.m. ET. Conference call and webcast details: Investors (domestic): Investors (international): (877) 407-0792 (201) 689-8263 To access a live webcast of the update, please use this link . 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 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; 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 PRIT Technology and potential benefits and applications thereof; the Company’s mission of delivering better and safer therapies to patients; expectations relating to key anticipated development milestones, including potential expansion and advancement of commercialization and development efforts, including potential indications, applications and geographies, 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,” “goal,” “objective,” 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 ability 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact: Courtney Dugan VP, Head of Investor Relations cdu@ymabs.com

ImmunotherapyDrug ApprovalFinancial Statement

01 Oct 2024

·www.globenewswire.com

Y-mAbs to Participate in Upcoming Investor Conferences in October

NEW YORK, Oct. 01, 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 its management team will participate in the following upcoming investor conferences: Oppenheimer Targeted Radiopharmaceutical Therapies in Oncology SummitDate: Tuesday, October 8, 2024Time: 9:30 a.m. ETLocation: New York, NYPanel: “The Next Wave of TRTs – Targets, Targeting Technologies and Isotopes” BMO Oncology SummitDate: Tuesday, October 8, 2024Time: 3:00 p.m. ETLocation: New York, NYFireside chat: “Shifting the Antibody Paradigm” About Y-mAbsY-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 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, 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,” “goal,” “objective,” 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; All statements are subject to the risks 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 quarterly period ended March 31, 2024, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 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® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact:Courtney DuganVP, Head of Investor Relationscdu@ymabs.com

ImmunotherapyDrug Approval

09 Sep 2024

·www.globenewswire.com

Y-mAbs Presents Neuroblastoma Research on Naxitamab and SADA PRIT Technology Platform at AACR Special Conference on Advances in Pediatric Cancer Research

Sept. 06, 2024 -- 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 new clinical and preclinical data from studies evaluating naxitamab and GD2-SADA, respectively, in neuroblastoma. The results are summarized in poster presentations scheduled to be presented September 6 – 7, 2024, at the American Academy of Cancer Research (“AACR”) Special Conference in the Advances in Pediatric Cancer Research in Toronto, Canada. Naxitamab maintains disease control in patients with refractory/relapsed high-risk neuroblastoma: A poster titled “Disease control in patients treated with naxitamab for refractory/relapsed high-risk neuroblastoma” (poster #B055) will be presented on September 7, 2024, during poster session B. This study analyzed the disease control rate with a 12-week minimum of stable disease from the start of naxitamab treatment, based on data from a prespecified interim analysis of Trial 201 (NCT03363373). Patients with refractory/relapsed high-risk neuroblastoma and residual disease in the bone and/or bone marrow who were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) achieved a disease control rate of 63%, with the results suggesting consistent disease control irrespective of baseline Curie score. “Naxitamab’s ability to maintain disease control provides an important measure for those who are most at risk for disease progression,” said Vignesh Rajah, MBBS, DCH, MRCP (UK), Chief Medical Officer. “The results reflect our deep commitment to advancing the science and therapeutic management of neuroblastoma.” High-affinity binding of GD2-SADA to Tb-DOTA: A poster titled “GD2-SADA, a bispecific fusion protein that forms self-assembling and disassembling (“SADA”), GD2-avid tetramers with high affinity for chelated radiolanthanides” (poster # A075) will be presented today, September 6, 2024, during poster session A. The study demonstrated tight binding interactions between GD2-SADA and DOTA-chelated terbium, a metal in the same lanthanide family as lutetium with multiple medical isotopes of potential benefit in diagnosis and therapy. Building on previous in vitro findings, the study also characterized the self-assembly and disassembly of GD2-SADA, a dynamic equilibrium that permits high avidity binding of non-radiolabeled GD2-SADA tetramers to GD2-expressing tumors and the renal clearance of disassembled monomers during the first step of pre-targeted radiotherapy (“PRIT”). In a preclinical model of neuroblastoma, also presented in the poster, the chelated radioisotope is administered during the second step of PRIT and binds to GD2-SADA on tumor cells, delivering cytotoxic radiation with minimal off-target exposure. The results have informed ongoing PK/PD modeling and the initial dosing in Trial 1001 (NCT05130255), a first-in-human Phase 1 trial of GD2-SADA PRIT with 177Lu-DOTA in adolescent and adult patients with GD2-positive solid tumors, and with Trial 1002 planned for pediatric patients with high-risk neuroblastoma. “The data highlight the importance of continued innovation in the treatment of high-risk neuroblastoma, an aggressive and relentless tumor, and the most common extracranial solid tumor in children,” said Dr Rajah. “We remain committed to unlocking the full potential of naxitamab and our novel SADA PRIT technology platform in our mission of improving the lives of patients.” 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 technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology. 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. 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). 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. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultImmunotherapyLicense out/inAACRDrug Approval

100 Deals associated with Naxitamab

External Link

KEGG	Wiki	ATC	Drug Bank
D11416	-	L01XC	DB15965

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
High Risk Neuroblastoma	US	Y-mAbs Therapeutics, Inc.	25 Nov 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteosarcoma, Recurrent	Phase 2	US	Memorial Sloan Kettering Cancer Center	01 Jul 2015
Osteosarcoma, Recurrent	Phase 2	US	Y-mAbs Therapeutics, Inc.	01 Jul 2015
Neuroblastoma	Phase 2	US	Memorial Sloan Kettering Cancer Center	01 Jul 2003
GD2 Positive Glioma	Phase 1	US	Y-mAbs Therapeutics, Inc.	15 Aug 2011
GD2 Positive Glioma	Phase 1	US	Memorial Sloan Kettering Cancer Center	15 Aug 2011
Small Cell Lung Cancer	Preclinical	-	Memorial Sloan Kettering Cancer Center	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03363373 (Trial 201, ASCO2024)	Phase 2	High Risk Neuroblastoma GD2	74	Naxitamab plus GM-CSF	znkcmtpjii(vzgbodjbtb) = ahrffmjoxy pbnqsmhnqh (nytwggntin )	Positive	24 May 2024
NCT03363373 (Trial 201, ASCO2024)	Phase 2	High Risk Neuroblastoma GD2 monoclonal antibodies	74	Naxitamab plus GM-CSF	dhuolrlznx(uhtdexvihg) = uxgmzwkctb vzmtkiafhv (gdgjruknqa ) View more	Positive	24 May 2024
Literature Manual	Not Applicable	High Risk Neuroblastoma	34	naxitamab+irinotecan+temozolomide+sargramostim	hakxoczitn(ozqemjnvjm) = hxcdynugyj bfovevdnmd (tafpptradz ) View more	Positive	03 Oct 2023
Literature Manual	Not Applicable	High Risk Neuroblastoma	34	naxitamab+irinotecan+temozolomide+sargramostim (early treatment)	hakxoczitn(ozqemjnvjm) = pqhdzgioyb bfovevdnmd (tafpptradz ) View more	Positive	03 Oct 2023
NCT03363373 (ESMO_IO2022) Manual	Phase 2	High Risk Neuroblastoma	74	Naxitamab 3mg/kg+GM-CSF	hggwaypijl(dcvxxelmni) = hypotension (58%) and pain (54%) jrjuxjouws (avjlyyvath )	Positive	08 Dec 2022
NCT03363373 (ASCO2022) Manual	Phase 2	High Risk Neuroblastoma	48	GM-CSF+Naxitamab	afhihsowdo(evncwsbjjm) = fvetjzprby tzresrhhoi (txjfdaksoz ) View more	Positive	02 Jun 2022
NCT00072358 (CTgov)	Phase 2	Neuroblastoma	291	anti-GD2 murine IgG3 monoclonal antibody 3F8	qkydpukjmi(mvrzwzugnt) = jbnaljvjro figlqxxfzd (ocopppcwth, eynfpdnrgv - qdabujkzre) View more	-	16 May 2022
NCT03363373 (Trial 201, ESMO2021)	Phase 2	High Risk Neuroblastoma	48	Naxitamab	hxjdcyqabo(uynylkxaiy) = Anti-drug antibody formation was observed in 10/46 (22%) patients assessed npevrgvufi (ygcpajaqer ) View more	-	17 Sep 2021
ASCO2021	Not Applicable	High Risk Neuroblastoma Consolidation	73	Naxitamab and GM-CSF	njmsboowgd(jqnicawrhk) = 2 aiugzbqzbq (ckfbharnug ) View more	Positive	28 May 2021
NCT03363373 (Trial 201, ASCO2021)	Phase 2	High Risk Neuroblastoma	22	Naxitamab	ygqcvxpfdt(xvnclwbrdv) = dygumaqpje ootdnhnibv (tsgpvbtvjg )	-	28 May 2021
NCT03363373 (ASCO2020)	Phase 2	High Risk Neuroblastoma	24	Naxitamab	omvtibydco(jcpctmgzfm) = 6 treatment-related SAEs were reported in 5 patients (anaphylactic reaction, pyrexia, and respiratory depression) vvnqhdigjd (iupzlactbg )	Positive	25 May 2020

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