Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune)(Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune))

概要

基本信息

药物类型

重组载体疫苗、治疗性疫苗

别名

Recombinant Saccharomyces cerevisiae-CEA (610D)

靶点

CEA

作用机制

CEA抑制剂(癌胚抗原抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [3]

在研适应症-

非在研适应症

结直肠癌肝细胞癌黑色素瘤+ [8]

原研机构

GlobeImmune, Inc.

在研机构-

非在研机构

ImmunityBio, Inc.

GlobeImmune, Inc.

NantKwest, Inc.

最高研发阶段终止临床2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

15

项与 Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune) 相关的临床试验

NCT03554109 / Withdrawn临床2期

An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

开始日期2018-09-01

申办/合作机构

ImmunityBio, Inc.

NCT03563144 / Withdrawn临床2期

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients with Metastatic Pancreatic Cancer.

开始日期2018-08-01

申办/合作机构

ImmunityBio, Inc.

NCT03169777 / Withdrawn临床1/2期

NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with recurrent and metastatic CRC.

开始日期2018-08-01

申办/合作机构

ImmunityBio, Inc.

100 项与 Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune) 相关的临床结果

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100 项与 Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune) 相关的转化医学

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100 项与 Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune) 相关的专利（医药）

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4

项与 Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune) 相关的文献（医药）

2011-09-01·Cancer Immunology, Immunotherapy2区 · 医学

Exploitation of differential homeostatic proliferation of T-cell subsets following chemotherapy to enhance the efficacy of vaccine-mediated antitumor responses

2区 · 医学

Article

作者: James W. Hodge ; David Apelian ; Jorge A. Caballero ; Sofia R. Gameiro ; Jack P. Higgins

The 5-year survival rate for stage IB-III non-small-cell lung cancer (NSCLC) remains 15%. Surgical resection followed by adjuvant chemotherapy with cisplatin and vinorelbine is one standard-of-care. We sought to determine in a preclinical model whether (a) the combination of cisplatin and vinorelbine could positively modulate components of the immune system independent of antitumor activity, and (b) there were synergistic effects of this drug combination and vaccine immunotherapy. We examined the effect of cisplatin/vinorelbine on gene expression, cell-surface phenotype, and CTL-mediated cytolysis of murine lung carcinoma cells in vitro; we also assessed the effects of cisplatin/vinorelbine on immune subsets and function of Tregs in vivo. Finally, we evaluated the potential synergy between chemotherapy and a recombinant yeast-CEA vaccine in a murine model transgenic for CEA with mice bearing lung tumors. These studies demonstrate that exposure of lung tumor cells to the platinum doublet cisplatin/vinorelbine modulates tumor cell phenotype and increases sensitivity to CTL-mediated cytolysis. These studies also demonstrate that cisplatin/vinorelbine (a) induces sub-myeloablative leucopenia that differentially modulates reconstitution of Treg versus effector T-cell subsets and (b) can be employed synergistically with vaccine, exploiting homeostatic peripheral expansion of T cells. Antitumor studies show for the first time that cisplatin/vinorelbine combined with vaccine increases the survival of mice with established NSCLC. These findings provide the rationale for the potential clinical benefit of the combined use of vaccine with cisplatin/vinorelbine chemotherapy regimens.

2000-11-01·Cancer Immunology, Immunotherapy2区 · 医学

The use of a rapid ELISPOT assay to analyze peptide-specific immune responses in carcinoma patients to peptide vs. recombinant poxvirus vaccines

2区 · 医学

Article

作者: J L Marshall ; A Chen ; P Arlen ; S M Steinberg ; K Y Tsang ; J M Hamilton ; D Poole ; J Schlom ; P H Hand

An enzyme-linked immunosorbent spot (ELISPOT) assay for interferon gamma production has been used to analyze specific T cell responses to a Flu 9-mer peptide, and a 9-mer peptide of carcinoembryonic antigen (CEA). Assays were performed on peripheral blood mononuclear cells (PBMC) of HLA-A2-positive patients with CEA-expressing carcinomas, both before and after vaccination with CEA-based vaccines, and from HLA-A2-positive healthy blood donors. The ELISPOT assay utilized aliquots of frozen PBMC, and assays were performed after 24 h in culture with peptide to rule out any artifacts due to long-term in vitro stimulation cycles. An internal standard was used for each assay to define reproducibility of the assay, and all samples from a given patient (pre- and post-vaccination, with both the Flu and CEA peptides) were analyzed simultaneously. The results indicated a trend towards healthy blood donors having higher levels of Flu-specific T cell precursors than do colon carcinoma patients, but these results were not statistically significant (P = 0.06). On the other hand, slightly higher CEA-specific T cell responses were observed in cancer patients with CEA-expressing carcinomas than in healthy blood donors. PBMC from two CEA-based vaccine clinical trials were analyzed for T cell responses to the same CEA peptide and to the Flu control peptide. The first trial consisted of three monthly vaccinations of CEA peptide (designated PPP) in adjuvant. The second trial consisted of cohorts receiving three monthly vaccinations of avipox-CEA recombinant (designated AAA) or cohorts receiving a primary vaccination with recombinant vaccinia-CEA followed by two monthly vaccinations with avipox-CEA (designated VAA). Few, if any, CEA-specific T cell responses were seen in the PPP vaccinations, while the majority of patients receiving the poxvirus CEA recombinants demonstrated increases in CEA-specific T cell responses and no increases in Flu-specific responses. CEA-specific IgG responses were also demonstrated in patients following recombinant CEA poxvirus vaccinations. Statistical analyses of the T cell responses to the same CEA peptide demonstrated a P value of 0.028 for the recombinant poxvirus vaccines, as compared with the peptide vaccine. There were no differences seen (P = 0.37) in Flu-specific responses after these two types of CEA vaccination. These results thus provide the first evidence that poxvirus recombinant-based vaccines are more potent in the initiation of tumor-antigen-specific T cell responses than vaccines employing peptide in adjuvant, when assays are conducted in an identical manner, and in defining responses to the same peptide. These results also demonstrate for the first time that an ELISPOT assay, performed over a 24-h period and without in vitro sensitization, can be successfully used to monitor immune responses to a tumor-associated antigen in cancer patients.

2000-01-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Human autoantibodies to carcinoembryonic antigen (CEA) induced by a vaccinia-CEA vaccine.

Article

作者: Allen, K O ; Lee, S ; Conry, R M ; Moore, S E ; LoBuglio, A F ; Shaw, D R

Carcinoembryonic antigen (CEA) is a well-characterized oncofetal glycoprotein whose overexpression by human adenocarcinomas has been a target for cancer immunotherapy. Limited information is available regarding the ability of patients to mount an antibody response to this self-antigen following vaccination. Recombinant vaccinia viruses encoding full-length or internally deleted cDNAs for human CEA were used to vaccinate 32 patients with CEA-expressing adenocarcinomas, predominantly of colorectal origin. CEA-specific autoantibodies were induced by vaccination in 7 of 32 patients. None of the patients had CEA antibodies detected before vaccination. CEA specificity of the antibodies initially identified by ELISA was confirmed by competitive inhibition analysis as well as recognition of recombinant CEA produced in baculovirus-infected insect cell cultures and human cell cultures by Western blot. The CEA autoantibodies were predominantly IgG1, with a minority of patients also demonstrating IgM autoantibodies. CEA antibodies were of low titer and low avidity, based on competitive inhibition assays. These autoantibodies did not affect clinical serum CEA protein quantitation. Furthermore, elevated serum CEA levels commonly encountered in patients with advanced adenocarcinoma did not hinder detection of low avidity polyclonal CEA antibodies. CEA antibodies such as those induced in these pilot trials are projected to have modest antitumor activity. Thus, additional Phase I/II trials of recombinant vaccinia-CEA with alternative prime-boost approaches and/or augmentation strategies are warranted in an effort to enhance the frequency and avidity of CEA-specific autoantibodies and cytolytic T cells before Phase III trials.

100 项与 Recombinant Saccharomyces cerevisiae-CEA(GlobeImmune) 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
结直肠癌	临床2期	美国	NantKwest, Inc.	2018-05-25
非小细胞肺癌	临床2期	-	ImmunityBio, Inc.	2018-02-01
鳞状细胞癌	临床2期	美国	NantKwest, Inc.	2018-01-13
黑色素瘤	临床2期	-	ImmunityBio, Inc.	2017-12-01
头颈部鳞状细胞癌	临床2期	-	ImmunityBio, Inc.	2017-12-01
尿路上皮癌	临床2期	-	ImmunityBio, Inc.	2017-12-01
三阴性乳腺癌	临床2期	-	ImmunityBio, Inc.	2017-12-01
三阴性乳腺癌	临床2期	-	ImmunityBio, Inc.	2017-12-01
甲状腺癌	临床2期	美国	GlobeImmune, Inc.	2013-04-26
甲状腺髓样癌	临床2期	美国	ImmunityBio, Inc.	2013-03-26

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03586869 (QUILT-3.080, CTgov)	临床1/2期	胰腺癌	3	Avelumab+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+haNK for infusion+Leucovorin+GI-6207+bevacizumab+Oxaliplatin+Capecitabine	糧憲夢鏇遞選襯鹽鏇餘(餘願糧廠製糧鹽膚齋選) = 鹹積簾窪糧鏇膚鬱繭遞鬱醖壓鬱壓網鏇積醖窪 (選積鏇襯憲築鬱餘醖壓, 壓鹽獵窪膚獵製鹹艱範 ~ 糧獵鏇廠製齋遞夢構鏇) 更多	-	2024-08-27
NCT03387085 (QUILT-3.067, CTgov)	临床1/2期	三阴性乳腺癌	9	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+5-fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	衊壓積壓鑰壓繭膚積淵(積襯觸簾鑰醖構觸繭鹹) = 窪遞鏇繭鬱製膚顧鬱壓鬱繭範築築夢築餘構觸 (鬱鹹壓範衊願壓顧願鹽, 積醖範艱膚積鹹艱鬱繭 ~ 壓淵窪繭壓襯餘觸壓觸) 更多	-	2024-08-09
NCT03387111 (CTgov)	临床1/2期	鳞状细胞癌	4	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+cetuximab+ETBX-061+ETBX-051+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	簾築鹹鬱繭鬱遞壓鏇獵(積獵膚選衊鏇餘糧鬱繭) = 網網廠獵壓觸鹹鏇網夢鬱醖願襯衊醖艱繭選繭 (鬱簾選構鏇簾網醖餘觸, 廠淵鑰築鏇構艱願簾糧 ~ 顧製遞構糧鏇衊糧廠窪) 更多	-	2024-08-05
NCT01856920 (QUILT-3.006, CTgov)	临床2期	甲状腺髓样癌	35	GI-6207 (Surveillance Subjects)	鹽壓鑰衊顧鏇築獵艱廠(築構鏇蓋淵簾膚淵網構) = 蓋構鹹夢製艱膚齋糧選夢憲夢願鏇積壓淵壓顧 (獵廠夢餘選鏇鹽鏇壓鏇, 選鹽鹽鏇製膚鹹繭鬱衊 ~ 糧構醖窪願餘繭鑰鏇獵) 更多	-	2024-07-09
NCT01856920 (QUILT-3.006, CTgov)	临床2期	甲状腺髓样癌	35	CEA (610D)+GI-6207 (Vaccine Subjects)	鹽壓鑰衊顧鏇築獵艱廠(築構鏇蓋淵簾膚淵網構) = 憲簾醖製淵衊憲襯衊淵夢憲夢願鏇積壓淵壓顧 (獵廠夢餘選鏇鹽鏇壓鏇, 繭廠觸簾艱艱積獵網鏇 ~ 壓壓餘壓淵糧襯繭膚窪) 更多	-	2024-07-09