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

权益机构-

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-

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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

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

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

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8

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

2020-05-01·Cancer Immunology Research1区 · 医学

Single-Cell Immune Competency Signatures Associate with Survival in Phase II GVAX and CRS-207 Randomized Studies in Patients with Metastatic Pancreatic Cancer

1区 · 医学

Article

作者: Nair, Nitya ; Müller, Thomas ; Chen, Shih-Yu ; Chang, Serena ; Murphy, Aimee ; Jaffee, Elizabeth M. ; Brockstedt, Dirk G. ; Lemmens, Ed ; Whiting, Chan ; Le, Dung T.

AbstractThe identification of biomarkers for patient stratification is fundamental to precision medicine efforts in oncology. Here, we identified two baseline, circulating immune cell subsets associated with overall survival in patients with metastatic pancreatic cancer who were enrolled in two phase II randomized studies of GVAX pancreas and CRS-207 immunotherapy. Single-cell mass cytometry was used to simultaneously measure 38 cell surface or intracellular markers in peripheral blood mononuclear cells obtained from a phase IIa patient subcohort (N = 38). CITRUS, an algorithm for identification of stratifying subpopulations in multidimensional cytometry datasets, was used to identify single-cell signatures associated with clinical outcome. Patients with a higher abundance of CD8+CD45RO−CCR7−CD57+ cells and a lower abundance of CD14+CD33+CD85j+ cells had improved overall survival [median overall survival, range (days) 271, 43–1,247] compared with patients with a lower abundance of CD8+CD45RO−CCR7−CD57+ cells and higher abundance of CD14+CD33+CD85j+ cells (77, 24–1,247 days; P = 0.0442). The results from this prospective–retrospective biomarker analysis were validated by flow cytometry in 200 patients with pancreatic cancer enrolled in a phase IIb study (P = 0.0047). The identified immune correlates provide potential prognostic or predictive signatures that could be employed for patient stratification.

2019-09-15·Clinical Cancer Research1区 · 医学

Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study)

1区 · 医学

Article

作者: Dirk G Brockstedt ; Noelle K. LoConte ; Dung T. Le ; Benjamin Musher ; Zev A. Wainberg ; Chan Whiting ; Erkut Borazanci ; Tony Reid ; Paul E. Oberstein ; Colin D. Weekes ; Vincent J Picozzi ; Elizabeth M. Jaffee ; Hedy Kindler ; Andrew H. Ko ; Daniel A. Laheru ; Todd Crocenzi ; Nitya Nair ; Aimee Murphy ; Michael A Morse ; Amanda Enstrom ; Herbert Zeh ; Sandy Ferber ; Andrea Wang-Gillam

AbstractPurpose:Limited options exist for patients with advanced pancreatic cancer progressing after 1 or more lines of therapy. A phase II study in patients with previously treated metastatic pancreatic cancer showed that combining GVAX pancreas (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes expressing mesothelin) resulted in median overall survival (OS) of 6.1 months, which compares favorably with historical OS achieved with chemotherapy. In the current study, we compared Cy/GVAX + CRS-207, CRS-207 alone, and standard chemotherapy in a three-arm, randomized, controlled phase IIb trial.Patients and Methods:Patients with previously treated metastatic pancreatic adenocarcinoma were randomized 1:1:1 to receive Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy (arm C). The primary cohort included patients who had failed ≥2 prior lines of therapy, including gemcitabine. The primary objective compared OS between arms A and C in the primary cohort. The second-line cohort included patients who had received 1 prior line of therapy. Additional objectives included OS between all treatment arms, safety, and tumor responses.Results:The study did not meet its primary efficacy endpoint. At the final study analysis, median OS [95% confidence interval (CI)] in the primary cohort (N = 213) was 3.7 (2.9–5.3), 5.4 (4.2–6.4), and 4.6 (4.2–5.7) months in arms A, B, and C, respectively, showing no significant difference between arm A and arm C [P = not significant (NS), HR = 1.17; 95% CI, 0.84–1.64]. The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea. No treatment-related deaths occurred.Conclusions:The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy. (ClinicalTrials.gov ID: NCT02004262)See related commentary by Salas-Benito et al., p. 5435

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

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.

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

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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
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
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	荷兰	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	美国	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
去势抵抗性前列腺癌	临床3期	-	Cell Genesys, Inc.	1999-05-01
去势敏感前列腺癌	临床3期	-	Cell Genesys, Inc.	1999-05-01

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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


AACR2020	N/A	转移性肾细胞癌	58	Immunotherapies (IO)	觸艱顧艱鏇餘窪選餘顧(壓鹹製築艱遞糧鹽簾獵) = 構範鹽餘鹽蓋艱繭選積餘鏇顧鏇鹽顧夢窪淵艱 (憲廠遞願鬱醖壓鹹餘積 ) 更多	-	2020-08-15
				Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitors (VEGF-TKI)	觸艱顧艱鏇餘窪選餘顧(壓鹹製築艱遞糧鹽簾獵) = 願窪製範窪顧壓選獵鏇餘鏇顧鏇鹽顧夢窪淵艱 (憲廠遞願鬱醖壓鹹餘積 ) 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)	鹹遞壓醖鹽廠顧鹹製鬱(膚齋襯鏇窪淵築鏇繭製) = 鏇繭選繭窪顧憲醖齋鏇鑰繭鬱廠鬱艱齋鑰餘餘 (範壓獵壓鹽觸窪鹽鏇壓, 鏇齋憲襯壓廠餘艱網齋 ~ 範築範鏇蓋遞鬱選積壓) 更多	-	2018-11-01
				GVAX+Cyclophosphamide+degarelix acetate (Cyclophosphamide, GVAX and Degarelix)	鹹遞壓醖鹽廠顧鹹製鬱(膚齋襯鏇窪淵築鏇繭製) = 壓獵襯襯淵鹽鑰夢糧積鑰繭鬱廠鬱艱齋鑰餘餘 (範壓獵壓鹽觸窪鹽鏇壓, 餘構網範夢廠襯壓構選 ~ 醖顧範憲觸構製窪壓遞) 更多
ASCO_SITC2018	N/A	microsatellite instability \| MSI-high	-	cancer immunotherapies (MSI-high tumors)	醖齋壓廠構製窪壓襯遞(襯夢鹽選鏇襯淵築餘鑰) = 鹹糧憲鑰廠獵壓繭衊鹽製繭憲顧網範鏇齋夢簾 (齋廠願壓遞淵選範襯鹹 )	-	2018-01-25
AACR2013	临床1期	前列腺癌	28	Prostate GVAX and ipilimumab	膚築簾鏇廠簾鹽夢糧簾(繭窪壓製網餘蓋遞淵淵) = 範淵簾鏇鏇齋鏇選蓋鬱簾獵積願鑰廠衊餘夢醖 (齋醖醖構壓構廠憲顧觸 ) 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	憲積積齋選鑰壓餘膚廠(窪鬱獵構夢衊顧築鏇鬱) = 鏇夢夢繭齋鏇憲鏇鹽醖夢壓鬱築窪製構網製繭 (繭壓鏇顧膚夢選醖窪窪 )	-	2010-04-15
				Prostate GVAX + Ipilimumab 5 mg/kg	憲積積齋選鑰壓餘膚廠(窪鬱獵構夢衊顧築鏇鬱) = 繭糧網蓋廠夢淵餘製夢夢壓鬱築窪製構網製繭 (繭壓鏇顧膚夢選醖窪窪 )