Delving into the Latest Updates on Litgenprostucel-L/GALGENPROSTUCEL-L with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, Immune cell therapy

Synonyms

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

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsUrogenital DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Adenocarcinoma of prostateAdvanced Lung Non-Small Cell CarcinomaAdvanced Prostate Carcinoma+ [4]

Originator Organization

Cell Genesys, Inc.

Active Organization-

Inactive Organization

Cell Genesys, Inc.Biosante Pharmaceuticals

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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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.

Start Date18 Jan 2013

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT01088789

/ Active, not recruitingPhase 2IIT

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.

Start Date20 Apr 2010

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

NCT00771017

/ WithdrawnPhase 2IIT

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.

Start Date01 Jul 2008

Sponsor / Collaborator

Eastern Cooperative Oncology Group

[+1]

100 Clinical Results associated with Litgenprostucel-L/GALGENPROSTUCEL-L

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100 Translational Medicine associated with Litgenprostucel-L/GALGENPROSTUCEL-L

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100 Patents (Medical) associated with Litgenprostucel-L/GALGENPROSTUCEL-L

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8

Literatures (Medical) associated with Litgenprostucel-L/GALGENPROSTUCEL-L

01 May 2020·Cancer Immunology ResearchQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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.

15 Sep 2019·Clinical Cancer ResearchQ1 · MEDICINE

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)

Q1 · MEDICINE

Article

Author: 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

01 Dec 2016·Cell Chemical BiologyQ1 · BIOLOGY

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

Q1 · BIOLOGY

Article

Author: 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.

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News (Medical) associated with Litgenprostucel-L/GALGENPROSTUCEL-L

27 Feb 2012

·www.biospace.com

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.

Vaccine

100 Deals associated with Litgenprostucel-L/GALGENPROSTUCEL-L

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 3	Sweden	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	United Kingdom	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	Canada	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	Netherlands	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	Belgium	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	United States	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	France	Cell Genesys, Inc.	01 Jul 2004
Metastatic castration-resistant prostate cancer	Phase 3	Germany	Cell Genesys, Inc.	01 Jul 2004
Castration-Resistant Prostatic Cancer	Phase 3	-	Cell Genesys, Inc.	01 May 1999
Castration-sensitive prostate cancer	Phase 3	-	Cell Genesys, Inc.	01 May 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2020	Not Applicable	Metastatic Renal Cell Carcinoma	58	Immunotherapies (IO)	tmckwksqzi(rhbmthglis) = ibhrajspno qxazikbhed (zkgofdcwfj ) View more	-	15 Aug 2020
				Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitors (VEGF-TKI)	tmckwksqzi(rhbmthglis) = yncdvypedq qxazikbhed (zkgofdcwfj ) View more
NCT01696877 (CTgov)	Phase 1/2	Localized Prostate Carcinoma \| Adenocarcinoma of prostate	29	degarelix acetate (Degarelix)	tylxjpxjgu(fwuitjjrhi) = dogrxaanlr mzsetfzqcr (gopxscrqbu, thhxitnijb - kitabasmkl) View more	-	01 Nov 2018
				GVAX+Cyclophosphamide+degarelix acetate (Cyclophosphamide, GVAX and Degarelix)	tylxjpxjgu(fwuitjjrhi) = regsafuhze mzsetfzqcr (gopxscrqbu, rzjbtbpqcx - yeufsqmmsl) View more
ASCO_SITC2018	Not Applicable	microsatellite instability \| MSI-high	-	cancer immunotherapies (MSI-high tumors)	gkfrhdwpaq(arkuxmysvl) = cofemzeokz aegmtllsts (xipysrtkpg )	-	25 Jan 2018
AACR2013	Phase 1	Prostatic Cancer	28	Prostate GVAX and ipilimumab	mzwpkhgfjf(sahxrrzulk) = ieusubtgld jjugjbdbfv (wffgvjnsgc ) View more	-	15 Apr 2013
AACR2010	Phase 1	Metastatic castration-resistant prostate cancer	28	Prostate GVAX + Ipilimumab 3 mg/kg	rxzsopdioi(qfgnapgecq) = tjaiindhgb rmroekcvvq (packivwnuj )	-	15 Apr 2010
				Prostate GVAX + Ipilimumab 5 mg/kg	rxzsopdioi(qfgnapgecq) = ortuszkrnq rmroekcvvq (packivwnuj )