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)

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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

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

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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

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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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5

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

20 Apr 2015·Journal of Clinical OncologyQ1 · MEDICINE

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

Q1 · MEDICINE

Article

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

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.

01 Dec 2014·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

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

Q2 · MEDICINE

ArticleOA

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

BACKGROUNDCancer-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.METHODSPatients 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.RESULTSSignificant 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.CONCLUSIONSOur 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.

01 Jun 2012·ImmunotherapyQ4 · MEDICINE

Combination Immunotherapy with Prostate GVAX and Ipilimumab: Safety and Toxicity

Q4 · MEDICINE

Article

Author: Karan, Dev ; Van Veldhuizen, Peter

Evaluation of: van den Eertwegh AJ, Versluis J, van den Berg HP et al. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a Phase 1 dose-escalation trial. Lancet Oncol. 13(5), 509–517 (2012). A significant interest in the development of therapeutic cancer vaccines over the last decade has led to an improvement in overall survival of cancer patients in several clinical trials. As a result, two active immunotherapy agents, sipuleucel-T and ipilimumab, have been approved by the US FDA for the treatment of prostate cancer and melanoma, respectively. GVAX® cellular vaccine (Cell Genesysis, Inc., CA, USA) is another active immunotherapy agent targeting prostate cancer and it has been well studied in various clinical trials. The current publication, by van den Eertwegh et al., demonstrated a combination of two active immunotherapy approaches, using GVAX and ipilimumab for the treatment of metastatic castration-resistant prostate cancer. While GVAX is designed to amplify the antitumor response specific to prostate cancer cells, ipilimumab contributes to T-cell activation. Thus, the authors presented the possibility of augmenting antitumor T-cell activity in two different ways. They successfully demonstrated a tolerable dose and safety profile of ipilimumab in combination with GVAX for patients with metastatic castration-resistant prostate cancer. However, further studies of such immunotherapy combinations and detailed analysis of their immunological effects are needed to observe clinical benefit.

1

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	France	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	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	Germany	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	Netherlands	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)	hworoaypqs(jcgfnjagqt) = hkuqvvvbrz lprobqsbpl (gwakjabcns ) View more	-	15 Aug 2020
				Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitors (VEGF-TKI)	hworoaypqs(jcgfnjagqt) = pmszawpxxf lprobqsbpl (gwakjabcns ) View more
NCT01696877 (CTgov)	Phase 1/2	Localized Prostate Carcinoma \| Adenocarcinoma of prostate	29	degarelix acetate (Degarelix)	uxlwhfogyc(iaqoxaemlj) = nljptxnyzv czdmhfbmrb (ifjyfpwjwn, trygwxcwun - bnnjeqsuid) View more	-	01 Nov 2018
				GVAX+Cyclophosphamide+degarelix acetate (Cyclophosphamide, GVAX and Degarelix)	uxlwhfogyc(iaqoxaemlj) = dvegeirbrf czdmhfbmrb (ifjyfpwjwn, qqcpnrgmtm - qzenshftsd) View more
ASCO_SITC2018	Not Applicable	microsatellite instability \| MSI-high	-	cancer immunotherapies (MSI-high tumors)	jletaptqia(qusiugezvl) = nbckiqacod bpqdeisgmp (thjlpqmjjh )	-	25 Jan 2018
AACR2013	Phase 1	Prostatic Cancer	28	Prostate GVAX and ipilimumab	rtkrbgeolr(jgefeoquro) = jvwqmbmowt ishagalqmu (vemoemhbko ) View more	-	15 Apr 2013
AACR2010	Phase 1	Metastatic castration-resistant prostate cancer	28	Prostate GVAX + Ipilimumab 3 mg/kg	savmpwmggc(wvjdwyqfdm) = fdkhowknxu qbhxvrspaw (ykzdddmftj )	-	15 Apr 2010
				Prostate GVAX + Ipilimumab 5 mg/kg	savmpwmggc(wvjdwyqfdm) = zywmnrqfef qbhxvrspaw (ykzdddmftj )