The purpose of this research study is to 1) evaluate the safety of a series of injections with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the immune system can be made stronger to eliminate the activated HIV virus.

Start Date01 Mar 2016

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

[+1]

NCT02042248 / CompletedPhase 1IIT

IGHID 1309 -A Phase I Study to Evaluate the Kinetics of the Immunologic Response and Virologic Impact of AGS-004 in HIV-Infected Individuals Suppressed on Antiretroviral Therapy Initiated During Acute and Chronic HIV Infection

The purpose of this study is to:
find out the intensity and duration of the immune response after multiple injections of the investigational study product AGS-004 made from one's own dendritic cells and one's own strain of HIV;
understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting CD4+ cells prior to and following administration of AGS- 004.
find out if low levels of HIV virus that are not detectable by standard HIV RNA assays will decrease following the administration of AGS-004.
find out if it is safe to give individuals with HIV multiple injections of AGS-004 made from the person's own dendritic cells and their own strain of HIV.
find out if administration of AGS-004 decreases the amount of latent HIV infection in resting CD4 cells

Start Date01 Mar 2014

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

[+2]

NCT01069809 / CompletedPhase 2

A Randomized, Double-Blind, Phase 2B Study Testing the Efficacy and Safety of AGS-004 on Host Control of HIV Replication During Analytical Treatment Interruption

The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the individuals are both taking antiretroviral therapy (ART) medication and interrupting ART medication.

Start Date01 Jul 2010

Sponsor / Collaborator

Argos Therapeutics, Inc.

100 Clinical Results associated with AGS-004

100 Translational Medicine associated with AGS-004

100 Patents (Medical) associated with AGS-004

Literatures (Medical) associated with AGS-004

01 Jan 2018·AIDS Research and Human RetrovirusesQ4 · MEDICINE

Immunogenicity of AGS-004 Dendritic Cell Therapy in Patients Treated During Acute HIV Infection

Q4 · MEDICINE

Article

Author: Tcherepanova, Irina Y. ; McGee, Kara S. ; Eron, Joseph J. ; Gamble, Alicia ; Gay, Cynthia L. ; Kearney, Mary F. ; DeBenedette, Mark A. ; Margolis, David M. ; Cope, Anna B. ; Archin, Nancie M. ; Nicolette, Charles A. ; Coffin, John M. ; Lewis, Whitney E. ; Hicks, Charles B. ; Kuruc, JoAnn D.

AGS-004 consists of matured autologous dendritic cells co-electroporated with in vitro transcribed RNA encoding autologous HIV antigens. In an open-label, single arm sub-study of AGS-004-003, AGS-004 was administered monthly to suppressed participants who started antiretroviral therapy (ART) during acute HIV infection. HIV-1 specific T cell responses were measured by multicolor flow cytometry after 3-4 doses. The frequency of resting CD4⁺ T-cell infection (RCI) was measured by quantitative viral outgrowth assay. Participants demonstrating increased immune response postvaccination were eligible for analytic treatment interruption (ATI). AGS-004 induced a positive immune response defined as ≥2-fold increase from baseline in the number of multifunctional HIV-1 specific CD28⁺/CD45RA^- CD8⁺ effector/memory cytoxic T-lymphocytes (CTLs) in all six participants. All participants underwent ATI with rebound viremia at a median of 29 days. Immune correlates between time to viral rebound and the induction of effector CTLs were determined. Baseline RCI was low in most participants (0.043-0.767 IUPM). One participant had a >2-fold decrease (0.179-0.067 infectious units per million [IUPM]) in RCI at week 10. One participant with the lowest RCI had the longest ATI. AGS-004 dendritic cell administration increased multifunctional HIV-specific CD28⁺/CD45RA^- CD8⁺ memory T cell responses in all participants, but did not permit sustained ART interruption. However, greater expansion of CD28^-/CCR7^-/CD45RA^- CD8⁺ effector T cell responses correlated with a longer time to viral rebound. AGS-004 may be a useful tool to augment immune responses in the setting of latency reversal and eradication strategies.

01 May 2016·JAIDS Journal of Acquired Immune Deficiency SyndromesQ3 · MEDICINE

Dendritic Cell Immunotherapy for HIV-1 Infection Using Autologous HIV-1 RNA

Q3 · MEDICINE

Article

Author: Jeffrey M. Jacobson ; Jean Pierre Routy ; David M. Asmuth ; Irina Tcherepanova ; Seth Welles ; David M. Margolis ; Kenneth Wood ; Mark DeBenedette ; Mehri McKellar ; David K. Stein ; Jonathan B. Angel ; Jean Guy Baril ; Benoit Trottier ; Charles Nicolette

BACKGROUNDThe genomic heterogeneity of HIV-1 impedes the ability of consensus sequences in vaccines to elicit effective antiviral immune responses. AGS-004 amplifies translation-competent RNA molecules encoding for Gag, Rev, Vpr, and Nef from the patient's autologous virus and loads them into dendritic cells.METHODSThis phase IIB, multicenter, 2:1 randomized, double-blind, placebo-controlled study enrolled 54 HIV-1-infected patients on antiretroviral therapy with viral loads (VLs) <50 copies per milliliter, current CD4 T-cell counts >450 cells per cubic millimeter, and nadir counts >200 cells per cubic millimeter, to receive intradermal injections of study product into the axillary lymph node region every 4 weeks. At week 16, a 12-week analytical treatment interruption (ATI) was undertaken.RESULTSThere was no difference in the end-of-ATI VL (average of values from weeks 11 and 12) between the 2 arms of the study [4.39 (4.17, 4.69) vs. 4.47 (3.76, 4.64) log10 HIV-1 RNA; P = 0.73]. Between arms, no change between pre-antiretroviral therapy VL and the end-of-ATI VL [-0.06 (0.24, -0.32) vs. -0.17 (0.17, -0.32) log10 HIV-1 RNA; P = 0.43] was observed. When interferon-γ, interleukin-2, tumor necrosis factor α, CD107a, and granzyme b expressions were measured by multicolor flow cytometry, a greater percentage of AGS-004 than of placebo recipients had multifunctional cytotoxic T-lymphocyte responses induced in the CD28+/CD45RA-CD8 effector/memory T-cell population to dendritic cells electroporated with autologous antigens. Adverse events consisted of transient, mild (grade 1) local injection site reactions.CONCLUSIONSDespite the induction of HIV-specific effector/memory CD8 T-cell responses, no antiviral effect was seen after the administration of AGS-004 when compared with placebo.

01 Dec 2013·JAIDS Journal of Acquired Immune Deficiency SyndromesQ3 · MEDICINE

Impact of Autologous Dendritic Cell–Based Immunotherapy (AGS-004) on B- and T-Cell Subset Changes and Immune Activation in HIV-Infected Patients Receiving Antiretroviral Therapy

Q3 · MEDICINE

Article

Author: Jenabian, Mohammad-Ali ; Tcherepanova, Irina Y. ; DeBenedette, Mark A. ; Routy, Jean-Pierre ; Nicolette, Charles A. ; Gilmore, Norbert

We previously reported that a combination of antiretroviral therapy with 4 monthly injections of each patient's own autologous dendritic cells (AGS-004) electroporated with CD40 ligand and with HIV RNA antigens obtained from each patient's own pre-antiretroviral therapy plasma induced HIV-specific CD8 T-cell responses in 10 patients. To assess other AGS-004-induced immune changes, we evaluated the modifications in B- and T-cell subsets and the level of immune activation in these patients. The proportion of Bm1 naive cells was increased along with an augmentation of the proliferation marker Ki67. Memory B-cell frequency, CD4 and CD8 T-cell subsets, regulatory T-cell frequency, and CD38/HLA-DR/PD-1 T-cell activation levels remained unchanged after AGS-004 dendritic cell immunotherapy.

News (Medical) associated with AGS-004

13 Oct 2009

·www.biospace.com

Argos Therapeutics, Inc. to Present Positive Immune Response and Viral Load Data for Arcelis(TM) HIV Program at the AIDS Vaccine 2009 Conference

DURHAM, N.C.--(BUSINESS WIRE)--Argos Therapeutics today announced the presentation of two abstracts at the AIDS Vaccine 2009 conference, being held October 19-22 in Paris, France. Favorable immune response, viral load and safety data from the ongoing Phase 2a proof-of-concept trial of AGS-004 therapy for the treatment of HIV will be discussed. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. The target population for the trial is HIV-1-infected patients with durable viral suppression from antiretroviral therapy (ART).

VaccineImmunotherapy

100 Deals associated with AGS-004

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	-	Kyowa Kirin Co., Ltd.	-
HIV Infections	Phase 2	-	McGill-Queen's University Press	-
Acquired Immunodeficiency Syndrome	Phase 1	CA	Argos Therapeutics, Inc.	01 Sep 2006
HIV Seropositivity	Phase 1	CA	Argos Therapeutics, Inc.	01 Sep 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AGS-004-001 (IAS2010)	Not Applicable	HIV Infections	38	AGS-004	qmepainozf(pphpsizdwm) = tddndfuasu efmvdeeded (yiqjopygoh )	Positive	01 Jan 2010

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