N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio)(N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio))

概要

基本信息

药物类型

治疗性疫苗

别名

CIMAVaxG vaccine、NGcGM3/VSSP vaccine、NGlycolyl GM3/Vssp vaccine

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

肿瘤皮肤和肌肉骨骼疾病

在研适应症-

非在研适应症

乳腺癌黑色素瘤

原研机构

Center For Molecular Immunology

在研机构-

非在研机构

Center For Molecular ImmunologyRecombio SL

最高研发阶段无进展临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio) 相关的临床试验

RPCEC00000220 / Suspended临床2/3期

Specific active immunotherapy with the vaccine NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer

开始日期2017-02-01

申办/合作机构

Center For Molecular Immunology

RPCEC00000223 / Recruiting临床2期

Specific active immunotherapy with the vaccine preparation NGcGM3/VSSP in the treatment of patients with metastatic cutaneous melanoma

开始日期2014-03-11

申办/合作机构

Center For Molecular Immunology

RPCEC00000068 / Completed临床2期

Active specific immunotherapy with NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer patient treatment. Phase II.

开始日期2002-08-27

申办/合作机构

Center For Molecular Immunology

100 项与 N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio) 相关的临床结果

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100 项与 N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio) 相关的转化医学

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100 项与 N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio) 相关的专利（医药）

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20

项与 N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio) 相关的文献（医药）

2021-02-25·Journal of Medicinal Chemistry1区 · 医学

Synthesis and Evaluation of Liposomal Anti-GM3 Cancer Vaccine Candidates Covalently and Noncovalently Adjuvanted by αGalCer

1区 · 医学

Article

作者: Yin, Xu-Guang ; Guo, Jun ; Wang, Xi-Feng ; Liu, Xiao-Peng ; Wang, Jian ; Liao, Chun-Miao ; Liu, Zheng ; Lu, Jie ; Zhang, Ru-Yan

GM3, a typical tumor-associated carbohydrate antigen, is considered as an important target for cancer vaccine development, but its low immunogenicity limits its application. αGalCer, an iNKT cell agonist, has been employed as an adjuvant via a unique immune mode. Herein, we prepared and investigated two types of antitumor vaccine candidates: (a) self-adjuvanting vaccine GM3-αGalCer by conjugating GM3 with αGalCer and (b) noncovalent vaccine GM3-lipid/αGalCer, in which GM3 is linked with lipid anchor and coassembled with αGalCer. This demonstrated that βGalCer is an exceptionally optimized lipid anchor, which enables the noncovalent vaccine candidate GM3-βGalCer/αGalCer to evoke a comparable antibody level to GM3-αGalCer. However, the antibodies induced by GM3-αGalCer are better at recognition B16F10 cancer cells and more effectively activate the complement system. Our study highlights the importance of vaccine constructs utilizing covalent or noncovalent assembly between αGalCer with carbohydrate antigens and choosing an appropriate lipid anchor for use in noncovalent vaccine formulation.

2018-05-08·Oncotarget

Synergistic potentiation of the anti-metastatic effect of anti EGFR mAb by its combination with immunotherapies targeting the ganglioside NGcGM3

Article

作者: Pérez, Adriana Carr ; Medinilla, Armando López ; Monzón, Kalet León ; Blanco, Rances ; Palomo, Addys González ; Barroso, María del Carmen ; Gabri, Mariano R. ; Segatori, Valeria

Several Anti-EGFR mAbs are register for the treatment of human cancer. However, their impact on patients overall survival has been limited by tumor resistance. N-Glycolyl variant of GM3 ganglioside (NGcGM3) is specifically expressed in some human tumors, and it has been associated with a poor prognosis. Several reports have documented that GM3 physically associates to EGFR inhibiting its ligand depend phosphorylation, but it also facilitates an alternative/compensatory signaling cascade mediated by Uroquinase Plasminogen Activator Receptor (uPAR) and integrin α5β1 interaction. However, the difference between NGc and N-Acetylated (NAc) variants of GM3 regarding such interactions is unknown. We hypothesized that enrichment of NGcGM3 expression in tumors relates to advantages of this ganglioside, on ensuring both EGFR and uPAR pathways optimal function. We explored the impact of combining an anti-EGFR (7A7 mAb) with anti-NGcGM3 therapies: NGcGM3/VSSP vaccine or 14F7 mAb. Both combinations synergistically increase overall survival in two models of lung metastasis: 3LL-D122 and 4T1; but combination with NGcGM3/VSSP vaccine is significantly more effective. In 3LL-D122-metastasis, of mice treated with the best combination, both EGFR and uPAR/α5β1 integrin pathways are turn off (I.e expression of uPAR/α5β1; and phosphorylation of EGFR, Stat3, Src and FAK are reduced); and tumor angiogenesis is decreased. Interestingly, combination treatment increases tumor infiltrating CD4⁺T, CD8⁺T and NK⁺-cells. Furthermore, a positive clinical outcome is reported for a cancer patient treated with an anti-EGFR mAb and anti-NGcGM3 therapy. Overall, our results support the combination of anti EGFR antibodies with therapies targeting NGcGM3 to increase their efficacy in future clinical trials.

2017-10-01·Journal of Immunotherapy4区 · 医学

Immunologic Response Elicited in Breast Cancer Patients Receiving a NeuGcGM3-based Vaccine as Adjuvant Therapy

4区 · 医学

Article

作者: Mazorra, Zaima ; Curbelo, Idelmis ; Lorenzo-Luaces, Patricia ; Fernandez, Luis E. ; Perez, Kirenia ; Vega, Aliz M. ; Mulens, Vladimir ; Rubio, Maria C. ; Estevez, Anabely ; Gonzalez, Zuyen ; Valdes-Zayas, Anet ; Crombet, Tania

This study aimed to investigate the immunogenicity of a cancer vaccine consisting of the NeuGcGM3 ganglioside combined with the outer membrane protein complex ofNeisseria meningitidesto form very small size particles. The vaccine is administered together with Montanide ISA51, as adjuvant treatment for breast cancer patients. After surgical resection and standard first-line chemo/radiotherapy, breast cancer patients in stage II–III were enrolled in a phase III clinical trial and allocated into 2 strata, according to the number of positive lymph nodes [stratum I (0–3); stratum II (≥4)]. Subsequently, patients were randomly assigned to receive the vaccine or placebo. The treatment consisted of 5 vaccine doses (200 μg) every 2 weeks and thereafter monthly reimmunizations to complete 15 doses. The vaccine was well-tolerated and high titers of immunoglobulin M and immunoglobulin G anti-NeuGcGM3 antibodies were similarly detected in each stratum. Hyperimmune sera were able to specifically recognize and kill the NeuGcGM3-expressing L1210 tumor cell line, and these functional capacities were significantly associated with a better clinical outcome in patients of stratum II. Besides, postimmune sera had the capacity to revert in vitro the immunosuppression induced by NeuGcGM3, as measured by the prevention of CD4 downmodulation on human T lymphocytes. Vaccination had no impact on the frequency of regulatory T cells or circulating NK cells. This study demonstrated, for the first time, the immunogenicity of the NeuGcGM3/VSSP/Montanide ISA 51 vaccine in the adjuvant setting and describes the functionality of induced anti-NeuGcGM3 antibodies as potential surrogate biomarkers of clinical benefit.

100 项与 N-Glycolyl GM3 cancer vaccine (Center of Molecular Immunology/Recombio) 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
黑色素瘤	临床3期	古巴	Center For Molecular Immunology	2014-04-02
乳腺癌	临床3期	古巴	Center For Molecular Immunology	2007-04-06

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临床结果

适应症

分期

评价

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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


ASCO2008	临床2期	黑色素瘤辅助	38	N-Acetyl-GM3/VSSP vaccine	(鏇窪淵鑰積衊願廠鑰鏇) = 窪網餘憲鹽鏇餘膚網夢艱膚構齋醖壓蓋夢壓廠 (繭鹽簾齋鹹範鹽廠醖積, 34–76) 更多	-	2008-05-20