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DRUG:

GD2-GD3 Vaccine

i
Other names: GD2-GD3 Vaccine, adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH, MV-NB-02
Associations
Company:
BioNTech, Memorial Sloan-Kettering Cancer Center, Y-mAbs Therap
Drug class:
GD2 ganglioside inhibitor, GD3 ganglioside inhibitor
Associations
11ms
GD2 and GD3 gangliosides as a diagnostic biomarkers for all stages and subtypes of ovarian cancer (BGCS 2023)
Conclusions A diagnostic model combining GD2/GD3 quantification in serum had diagnostic power for all subtypes and all stages of OC, including early-stage. Future work will aim to validate these biomarkers in independent prospective studies.
MUC16 (Mucin 16, Cell Surface Associated)
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GD2-GD3 Vaccine
12ms
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (clinicaltrials.gov)
P1/2, N=374, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2023 --> May 2025 | Trial primary completion date: May 2023 --> May 2025
Trial completion date • Trial primary completion date • Combination therapy
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa) • ITGB2 (Integrin Subunit Beta 2)
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MYCN amplification
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GD2-GD3 Vaccine
1year
GD2 and GD3 gangliosides as diagnostic biomarkers for all stages and subtypes of epithelial ovarian cancer. (PubMed, Front Oncol)
A diagnostic model that included serum levels of GD2+GD3+age was superior to the standard of care (CA125, p<0.001) in diagnosing OC and early-stage (I/II) OC...A diagnostic model combining GD2 and GD3 quantification in serum had diagnostic power for all subtypes and all stages of OC, including early stage. Further research exploring the utility of GD2 and GD3 for diagnosis of OC is warranted.
Journal
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MUC16 (Mucin 16, Cell Surface Associated)
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GD2-GD3 Vaccine
over1year
Effect of Oral β-Glucan on Antibody Response to Ganglioside Vaccine in Patients With High-Risk Neuroblastoma: A Phase 2 Randomized Clinical Trial. (PubMed, JAMA Oncol)
Among patients with high-risk relapsed metastatic neuroblastoma, oral β-glucan adjuvant during GD2/GD3 ganglioside vaccine boost has stimulated IgG antibody response, which was associated with improved survival; however, the effectiveness of oral β-glucan during the vaccine priming phase remains unproven...Alternative or additional adjuvants may be needed to enhance seroconversion. ClinicalTrials.gov Identifier: NCT00911560.
Clinical • P2 data • Journal
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CLEC7A (C-Type Lectin Domain Containing 7A)
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GD2-GD3 Vaccine
2years
Anti-GD2 Directed Immunotherapy for High-Risk and Metastatic Neuroblastoma. (PubMed, Biomolecules)
The use of anti-GD2/GD3 tumor vaccine is a novel and potential approach to minimizing late relapse. How to induce GD2 expression from tumor cells using the epigenetic approach is a hot topic nowadays. We expect that anti-GD2 treatment can serve as a model for the use of monoclonal antibody immunotherapy against cancers in the future.
Review • Journal • IO biomarker
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IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
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GD2-GD3 Vaccine
over2years
Ganglioside GD2: a novel therapeutic target in triple-negative breast cancer. (PubMed, Ann N Y Acad Sci)
The ganglioside GD2 has been shown to be upregulated in primary TNBC tumors compared with normal breast tissue and has been shown to identify BCSCs. In this review, we discuss GD2 as a BCSC- and tumor-specific marker in TNBC; epithelial-to-mesenchymal transition and the signaling pathways that are upstream and downstream of GD2 and the role of these pathways in tumorigenesis and metastasis in TNBC; direct and indirect approaches for targeting GD2; and ongoing clinical trials and treatments directed against GD2 as well as future directions for these strategies.
Review • Journal
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CD44 (CD44 Molecule) • CD24 (CD24 Molecule)
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Unituxin (dinutuximab) • GD2-GD3 Vaccine
over2years
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (clinicaltrials.gov)
P1/2, N=374, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023
Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
MYCN amplification
|
GD2-GD3 Vaccine
almost3years
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (clinicaltrials.gov)
P1/2, N=296, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2021 --> May 2022 | Trial primary completion date: May 2021 --> May 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
MYCN amplification
|
GD2-GD3 Vaccine
4years
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (clinicaltrials.gov)
P1/2, N=296, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2020 --> May 2021 | Trial primary completion date: May 2020 --> May 2021
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
MYCN amplification
|
GD2-GD3 Vaccine