Litgenprostucel-L/GALGENPROSTUCEL-L(Litgenprostucel-L/GALGENPROSTUCEL-L)

概要

基本信息

药物类型

治疗性疫苗、免疫细胞疗法

别名

GVAX Pancreas、GVAX Prostate、PC3/LNCaP(Cell Genesys)

+ [1]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

肿瘤泌尿生殖系统疾病呼吸系统疾病

在研适应症-

非在研适应症

前列腺腺癌晚期非小细胞肺癌晚期前列腺癌+ [4]

原研机构

Cell Genesys, Inc.

在研机构-

非在研机构

Cell Genesys, Inc.Biosante Pharmaceuticals

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

13

项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的临床试验

NCT01696877

/ Completed临床1/2期IIT

A Neoadjuvant Immunologic Study of Androgen Deprivation Therapy Combined With a Granulocytemacrophage-colony Stimulating Factor F-secreting Allogeneic Prostate Cancer Vaccine and Low-dose Cyclophosphamide in Men With High-risk Localized Prostate Cancer Undergoing Radical Prostatectomy

This research is being done to see if an investigational prostate cancer vaccine, called GVAX, can safely be given together with a single intravenous injection of a drug called cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands who have also received standard hormonal therapy.

开始日期2013-01-18

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT01088789

/ Active, not recruiting临床2期IIT

A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene

The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, tail or the uncinate process of the pancreas.

开始日期2010-04-20

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

NCT00771017

/ Withdrawn临床2期IIT

A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. It is not yet known whether androgen ablation therapy is more effective with or without vaccine therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well it works when given together with or without vaccine therapy in treating patients with prostate cancer.

开始日期2008-07-01

申办/合作机构

Eastern Cooperative Oncology Group

[+1]

100 项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的临床结果

登录后查看更多信息

100 项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的转化医学

登录后查看更多信息

100 项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的专利（医药）

登录后查看更多信息

6

项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的文献（医药）

2016-12-01·Cell chemical biology1区 · 生物学

Whole-Cell Cancer Vaccines Induce Large Antibody Responses to Carbohydrates and Glycoproteins

1区 · 生物学

Article

作者: Xia, Li ; Gildersleeve, Jeffrey C ; Schrump, David S

Whole-cell cancer vaccines are a promising strategy for treating cancer, but the characteristics of a favorable immune response are not fully understood. New insights could enable development of better vaccines, discovery of new antigens, and identification of biomarkers of efficacy. Using glyco-antigen microarrays, we demonstrate that GVAX Pancreas (a granulocyte macrophage colony-stimulating factor-modified whole-cell tumor vaccine) induces large immunoglobulin G and immunoglobulin M responses to many antigens, including tumor-associated carbohydrates, blood group antigens, α-Gal, and bovine fetuin. Antibody responses to α-Gal, a glycan found in fetal bovine serum (FBS) used to produce the vaccine, correlated inversely with overall survival and appear to compete with productive responses to the vaccine. H1299 lysate vaccine, produced with FBS, also induced responses to α-Gal and fetuin but not K562-GM, which is produced in serum-free medium. Our results provide new potential biomarkers to evaluate productive/unproductive immune responses and suggest that removal/reduction of FBS could improve the efficacy of whole-cell vaccines.

2015-04-20·Journal of clinical oncology : official journal of the American Society of Clinical Oncology1区 · 医学

Safety and Survival With GVAX Pancreas Prime and Listeria Monocytogenes–Expressing Mesothelin (CRS-207) Boost Vaccines for Metastatic Pancreatic Cancer

1区 · 医学

Article

作者: Skoble, Justin ; Onners, Beth ; Lemmens, Ed ; Greten, Tim F. ; Picozzi, Vincent ; Springett, Gregory ; Dubensky, Thomas ; Cohen, Deirdre ; Laheru, Daniel A. ; Jaffee, Elizabeth M. ; Zeh, Herbert ; Solt, Sara ; Le, Dung T. ; Grous, John ; Lutz, Eric R. ; Morse, Michael ; Wang-Gillam, Andrea ; Brockstedt, Dirk G. ; Uram, Jennifer N. ; Fine, Robert L. ; Murphy, Aimee Luck ; Crocenzi, Todd

Purpose:

GVAX pancreas, granulocyte-macrophage colony-stimulating factor–secreting allogeneic pancreatic tumor cells, induces T-cell immunity to cancer antigens, including mesothelin. GVAX is administered with low-dose cyclophosphamide (Cy) to inhibit regulatory T cells. CRS-207, live-attenuated Listeria monocytogenes–expressing mesothelin, induces innate and adaptive immunity. On the basis of preclinical synergy, we tested prime/boost vaccination with GVAX and CRS-207 in pancreatic adenocarcinoma.

Patients and Methods:

Previously treated patients with metastatic pancreatic adenocarcinoma were randomly assigned at a ratio of 2:1 to two doses of Cy/GVAX followed by four doses of CRS-207 (arm A) or six doses of Cy/GVAX (arm B) every 3 weeks. Stable patients were offered additional courses. The primary end point was overall survival (OS) between arms. Secondary end points were safety and clinical response.

Results:

A total of 90 patients were treated (arm A, n = 61; arm B, n = 29); 97% had received prior chemotherapy; 51% had received ≥ two regimens for metastatic disease. Mean number of doses (± standard deviation) administered in arms A and B were 5.5 ± 4.5 and 3.7 ± 2.2, respectively. The most frequent grade 3 to 4 related toxicities were transient fevers, lymphopenia, elevated liver enzymes, and fatigue. OS was 6.1 months in arm A versus 3.9 months in arm B (hazard ratio [HR], 0.59; P = .02). In a prespecified per-protocol analysis of patients who received at least three doses (two doses of Cy/GVAX plus one of CRS-207 or three of Cy/GVAX), OS was 9.7 versus 4.6 months (arm A v B; HR, 0.53; P = .02). Enhanced mesothelin-specific CD8 T-cell responses were associated with longer OS, regardless of treatment arm.

Conclusion:

Heterologous prime/boost with Cy/GVAX and CRS-207 extended survival for patients with pancreatic cancer, with minimal toxicity.

2014-12-01·Journal for immunotherapy of cancer2区 · 医学

Myeloid derived suppressor and dendritic cell subsets are related to clinical outcome in prostate cancer patients treated with prostate GVAX and ipilimumab

2区 · 医学

ArticleOA

作者: de Gruijl, Tanja D ; Hege, Kristen ; Scheper, Rik J ; Stam, Anita Gm ; Santegoets, Saskia Jam ; Sacks, Natalie ; Lougheed, Sinéad M ; Gall, Helen ; Gerritsen, Winald R ; Lowy, Israel ; Jooss, Karin ; van den Eertwegh, Alfons Jm

BACKGROUND:

Cancer-related disturbances in myeloid lineage development, marked by high levels of myeloid-derived suppressor cells (MDSC) and impaired dendritic cell (DC) development, are associated with poor clinical outcome due to immune escape and therapy resistance. Redressing this balance may therefore be of clinical benefit. Here we investigated the effects of combined Prostate GVAX/ipilimumab immunotherapy on myeloid subsets in peripheral blood of castration-resistant prostate cancer (CRPC) patients as well as the putative predictive value of baseline and on-treatment myeloid parameters on clinical outcome.

METHODS:

Patients with CRPC (n = 28) received thirteen intradermal administrations of Prostate GVAX, consisting of two allogeneic GM-CSF-transduced and irradiated prostate cancer cell lines (LN-CaP and PC3) and six infusions of escalating doses of anti-CTLA4/ipilimumab. Frequencies and activation status of peripheral blood DC (PBDC) and MDSC were determined before, during and after treatment by flowcytometric analysis and related to clinical benefit.

RESULTS:

Significant treatment-induced activation of conventional and plasmacytoid DC subsets (cDC and pDC) was observed, which in the case of BDCA1/CD1c(+) cDC1 and MDC8(+)/6-sulfoLacNAc(+) inflammatory cDC3 was associated with significantly prolonged overall survival (OS), but also with the development of autoimmune-related adverse events. High pre-treatment levels of CD14(+)HLA-DR(-)monocytic MDSC (mMDSC) were associated with reduced OS. Unsupervised clustering of these myeloid biomarkers revealed particular survival advantage in a group of patients with high treatment-induced PBDC activation and low pretreatment frequencies of suppressive mMDSC in conjunction with our previously identified lymphoid biomarker of high pretreatment CD4(+)CTLA4(+) T cell frequencies.

CONCLUSIONS:

Our data demonstrate that DC and MDSC subsets are affected by prostate GVAX/ipilimumab therapy and that myeloid profiling may contribute to the identification of patients with possible clinical benefit of Prostate GVAX/ipilimumab treatment.

2

项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的新闻（医药）

2022-05-23

·药明康德

助力乳腺癌和前列腺癌早期诊断，两款AI诊断软件获FDA批准

近日，RadNet宣布其两家子公司开发的两款AI诊断软件——DeepHealth Saige-DX乳腺X射线摄影（mammography）产品和Quantib前列腺2.0 MRI AI算法获美国FDA批准。 Saige-Dx是已获批的Saige-Q工作列表分类软件的升级版，是一种癌症检测工具，使放射科医生能够使用AI更有效地检测是否存在乳腺癌。DeepHealth强大的新AI技术可自动识别乳房X光照片中的可疑病变，并为每个可疑病变和整个病例分配可疑级别。它有助于及早发现和诊断乳腺癌。 Saige-Dx的获批是基于此前一项研究的数据，在该研究中18名放射科医生在使用Saige-Dx时取得更好的表现，体现在使用该软件时检测到的癌症百分比的增加和较低的假阳性率。“Saige-Dx建立在我们先进的深度学习算法之上。正如去年Nature Medicine的一篇文章中所述，我们高度准确的AI显示出比专业的乳腺成像放射科医生早一到两年发现癌症的能力。Saige-Dx的获批代表着在推进癌症护理方面又向前迈进了一步。使用我们的软件工具的医生给出了积极的反馈，该软件使他们在解释乳房X光检查图像时更加准确和高效，”DeepHealth首席执行官兼联合创始人Gregory Sorensen医学博士说。 Quantib Prostate是一种基于AI的软件解决方案，可推进MRI前列腺报告工作流程。该解决方案附带一套工具来提高报告质量和速度。Quantib Prostate的重大升级已获得FDA的510（K）认证。 RadNet总裁兼首席执行官Howard Berger博士说：“我们对两家子公司DeepHealth和Quantib的旗舰产品获批感到非常高兴。AI将对放射学和癌症产生变革性影响，我们致力于为患者和医疗保健提供者提供这些进步。在未来几十年，我们相信这些AI工具将在癌症的早期发现和诊断中发挥重要作用，从而提高生存率和改善治疗效果。” 参考资料： 1. RadNet Artificial Intelligence Subsidiaries, DeepHealth and Quantib, Obtain FDA Clearance for Mammography and Prostate AI Tools，Retrieved May 16, 2022, from https://www.globenewswire.com/news-release/2022/05/16/2443575/10985/en/RadNet-Artificial-Intelligence-Subsidiaries-DeepHealth-and-Quantib-Obtain-FDA-Clearance-for-Mammography-and-Prostate-AI-Tools.html 内容来源于网络，如有侵权，请联系删除，谢谢

诊断试剂放射疗法

2012-02-27

·BioSpace

BioSante Pharmaceuticals, Inc.’s Pancreas Cancer Vaccine Shows over 60% Survival Increase in Newly Presented Study

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced presentation of results from a Phase Ib clinical study that show its GVAX Pancreas cancer vaccine increased the median survival of pancreatic cancer patients with previously treated, locally advanced or metastatic pancreatic adenocarcinoma (PDA), from 3.3 months when treated with ipilimumab (IPI; Yervoy; BMS), to 5.5 months on the combination of IPI plus GVAX Pancreas, an increase of more than 60 percent. The study was not powered for a direct comparison. In addition, the IPI/GVAX Pancreas combination demonstrated an increase in one year survival, from 7 percent to 27 percent. A new multicenter clinical study is planned to begin this year.

疫苗

100 项与 Litgenprostucel-L/GALGENPROSTUCEL-L 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床3期	美国	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	比利时	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	加拿大	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	法国	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	德国	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	荷兰	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	瑞典	Cell Genesys, Inc.	2004-07-01
转移性去势抵抗性前列腺癌	临床3期	英国	Cell Genesys, Inc.	2004-07-01
前列腺腺癌	临床2期	美国	Biosante Pharmaceuticals	2013-01-18
局限性前列腺癌	临床2期	美国	Biosante Pharmaceuticals	2013-01-18

登录后查看更多信息

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


AACR2020	N/A	转移性肾细胞癌	58	Immunotherapies (IO)	選齋醖蓋夢願鹽窪醖鬱(獵糧襯構繭網壓蓋襯構) = 衊繭窪窪蓋範壓艱鹹積遞鑰廠鹹簾願鬱齋衊觸 (鹽繭淵選蓋繭憲鏇窪襯 ) 更多	-	2020-08-15
				Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitors (VEGF-TKI)	選齋醖蓋夢願鹽窪醖鬱(獵糧襯構繭網壓蓋襯構) = 鹽觸鑰壓積網艱遞窪窪遞鑰廠鹹簾願鬱齋衊觸 (鹽繭淵選蓋繭憲鏇窪襯 ) 更多
NCT01696877 (CTgov)	临床1/2期	局限性前列腺癌 \| 前列腺腺癌	29	degarelix acetate (Degarelix)	鹹簾餘艱範淵鑰簾壓獵(顧簾製淵願淵鹽鏇選範) = 顧遞壓糧觸築膚簾衊選選膚鬱遞選齋憲構廠鬱 (鑰淵艱鬱淵醖蓋廠艱鹹, 憲遞顧獵顧選築壓積艱 ~ 繭艱繭餘膚築鏇遞鹹鬱) 更多	-	2018-11-01
				GVAX+Cyclophosphamide+degarelix acetate (Cyclophosphamide, GVAX and Degarelix)	鹹簾餘艱範淵鑰簾壓獵(顧簾製淵願淵鹽鏇選範) = 鑰網觸製積蓋願膚衊積選膚鬱遞選齋憲構廠鬱 (鑰淵艱鬱淵醖蓋廠艱鹹, 夢夢製鑰膚築鏇網網製 ~ 鹹壓獵壓糧淵淵簾構廠) 更多
ASCO_SITC2018	N/A	microsatellite instability \| MSI-high	-	cancer immunotherapies (MSI-high tumors)	憲顧糧糧壓壓範願衊獵(簾繭膚憲廠夢鹹構齋蓋) = 觸鏇齋襯獵顧壓艱衊餘廠鏇築鹹鹹淵築醖網構 (網願蓋窪鏇鏇齋壓艱觸 )	-	2018-01-25
AACR2013	临床1期	前列腺癌	28	Prostate GVAX and ipilimumab	醖觸衊醖憲獵襯鏇築繭(淵顧簾觸壓鑰壓鏇繭獵) = 淵範觸鏇夢顧壓繭顧簾築膚淵繭積蓋網壓鏇衊 (窪憲窪鏇襯糧簾觸壓選 ) 更多	-	2013-04-15
AACR2010	临床1期	转移性去势抵抗性前列腺癌	28	Prostate GVAX + Ipilimumab 3 mg/kg	願餘糧夢壓觸鏇襯鹽願(艱鑰糧艱齋壓選製膚構) = 網齋鑰憲餘觸繭壓廠醖餘網夢醖醖築鹹鹹憲壓 (壓願蓋願淵衊顧鏇鬱積 )	-	2010-04-15
				Prostate GVAX + Ipilimumab 5 mg/kg	願餘糧夢壓觸鏇襯鹽願(艱鑰糧艱齋壓選製膚構) = 鹹獵鹽繭艱蓋簾顧鑰廠餘網夢醖醖築鹹鹹憲壓 (壓願蓋願淵衊顧鏇鬱積 )