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Argos Therapeutics Presents Positive Phase 2 Viral Load and Immune
Response Data for Arcelis™ HIV Program at the
AIDS Vaccine 2009 Conference
Personalized Immunotherapy Candidate Demonstrates:
• Viral Load Control in Absence of Antiretroviral Therapy
• Robust Immune Response to a Diverse Set of HIV Antigens
• Potential to Offer Independence from Antiretroviral Therapy
Durham, NC and Paris, France- October 21, 2009 — Argos Therapeutics today announced two
presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and
safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. 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
presentations contained important results, including a favorable safety profile for AGS-004, the ability to
induce partial to complete viral load control in the absence of antiretroviral therapy (ART) during a 12-
week structured treatment interruption (STI), and a potent and diverse immune response to AGS-004
treatment. These AGS-004 results are unprecedented for an immunotherapeutic candidate in HIV and, if
confirmed in an upcoming randomized study, could lead to a new treatment paradigm for HIV.
“The Arcelis approach to immunotherapy has broad potential as a new therapeutic strategy to combat
HIV,” said Jean-Pierre Routy, M.D., from McGill University Health Centre in Montreal. “The level of
viral load control in response to AGS-004 has been unexpectedly strong compared to what has been
reported for other immunotherapies tested in similar patient populations. Additionally, because this
approach uses patient-specific HIV antigens, it may overcome the extreme genetic heterogeneity of HIV
from patient to patient, which has been one of the reasons for the failure of prior HIV immunotherapies.”
In an oral presentation, Dr. Routy, principal investigator of the ongoing Phase 2a trial, discussed data
assessing the safety and impact of AGS-004 in controlling viral load during a 12-week STI from ART.
Patients enrolled in the trial had pre-ART viral load levels ranging between 10,000-500,000 copies/mL.
Data were presented for 16 patients that had successfully completed the STI. After the three month
treatment break from ART, 13 of 16 patients had a lower viral load compared to their pre-ART levels,
with a mean reduction of greater than 1 Log, corresponding to a greater than 80% reduction from pre-
ART levels. AGS-004 also exhibited a favorable side-effect and safety profile, with no reports of
autoimmunity or AIDS-defining events during the STI, and no treatment-related serious adverse events
Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of
Argos Therapeutics, commented, “These data demonstrate that AGS-004 may make a significant impact
on pre-ART viral load levels during an STI, and that it is potentially able to keep patients safely off of
ART for at least three months. Most of the patients in this trial were chronically infected, and did not have
a genetic predisposition to viral control. Therefore, the large reduction in viral load from pre-ART is a
very promising outcome. These data provide strong support for one of the main therapeutic objectives of
AGS-004, that it could potentially offer patients partial or complete independence from ART, thereby
addressing the side effects, resistance, and compliance issues associated with ART and improving
patients´ quality of life.”
In a poster session, Bader Yassine-Diab, Ph.D., from the National Immunomonitoring Laboratory
(NIML) at the University of Montreal Research Center, presented additional data supporting patients´
immune response to the autologous HIV antigens used in AGS-004 – Gag, Nef, Rev, and Vpr – following
STI. Researchers analyzed patients´ anti-HIV-specific immune responses by evaluating the proliferation
and the functionality of CD8+ and CD4+ T cells stimulated with these autologous HIV antigens.
Preliminary results indicated an increase in HIV-specific CD8+ T-lymphocyte polyfunctional populations
following immunotherapy with AGS-004, which was accentuated after the STI from ART.
“Although still preliminary, we are impressed with the diversity and strength of the immune responses
observed so far. Importantly, the immune responses were composed of the same types of T cells observed
in long-term non-progressors, which are individuals who are infected with HIV, but whose infection does
not rapidly progress to AIDS,” said Rafick Sekaly, Ph.D., Scientific Director of the NIML.
Based on these positive data from the current Phase 2a study, Argos is planning on initiating a Phase 2b
trial in the first half of 2010. The majority of the costs of this next trial will be funded by the National
Institutes of Health, as part of a $21 million contract that Argos was awarded in 2006.
The first abstract, titled, “Safety and Viral Load Changes in HIV-1 Infected Subjects Treated with
Autologous Dendritic Immune Therapy Following ART Discontinuation,” was authored by J.P. Routy,
M.R. Boulassel, M.R. Loutty, S. Vezina, C. Tremblay, J. Angel, J. Gill, J. Baril, F. Smaill, R. Jain, D.
Healey, I. Tcherepanova, C. Nicolette, and R. Sekaly.
The second abstract, titled, “Immunogenicity of an Autologous Dendritic Cell Anti-HIV Therapy in HIV-
1 Infected Individuals,” was authored by B. Yassine-Diab, Z. Coutsinos, C. Landry, D. Gagnon, D.
Sauve, C. Hebert-Benoit, V. Hebert, M.R. Boulassel, J.P. Routy, R. Jain, I. Tcherepanova, D. Healey, C.
Nicolette, and R. Sekaly.
This work was funded in part with Federal funds from the National Institute of Allergy and Infectious
Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No.
About the Arcelis™ Technology
Arcelis is Argos´ proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies
for HIV, other infectious diseases, and cancer. This platform is based on optimizing a patient´s own
(autologous) dendritic cells to trigger a pathogen- or tumor-specific immune response. To address the
challenge of the unique genetic profile of each patient´s disease and the genetic mutations of that disease,
Argos loads the autologous dendritic cells with a sample of messenger RNA (“mRNA”) isolated from
their disease. Through this process, dendritic cells can potentially prime immune responses to the entire
antigenic repertoire, resulting in an immunotherapeutic that is customized to the patient’s specific disease.
The development of Arcelis is part of Argos´ broad collaboration with Kyowa Hakko Kirin Co., Ltd.
About Argos Therapeutics, Inc.
Argos is an immunotherapy company developing new treatments for cancer, infectious and
autoimmune diseases, and transplantation rejection. The Company has generated multiple
platform technologies and a diverse pipeline of products based on its expertise in the biology of
dendritic cells — the master switch that turns the immune system on or off.
MacDougall Biomedical Communications
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