Argos Therapeutics Presents Research Validating Feasibility and Safety of its Arcelis Personalized Immunotherapy Platform for HIV

Argos Therapeutics today announced the presentation of two abstracts related to its Arcelis™ HIV immunotherapy program at the 18th Annual Canadian Conference on HIV/AIDS Research, held in Vancouver April 23-25th, 2009

DURHAM, NC, USA | April 24, 2009 | Argos Therapeutics today announced the presentation of two abstracts related to its Arcelis™ HIV immunotherapy program at the 18th Annual Canadian Conference on HIV/AIDS Research, held in Vancouver April 23-25th, 2009. These abstracts, presented by Argos’ collaborators at McGill University Health Centre, detail research validating the feasibility and safety of the AGS-004 immunotherapy candidate for HIV, as well as the apheresis collection procedure used to generate the immunotherapy product. AGS-004 is a personalized immunotherapy, generated by the Arcelis platform, which consists of patient-specific, monocyte-derived dendritic cells and RNA encoding autologous HIV antigens, and is perfectly matched to each patient’s unique viral burden.

“These abstracts provide additional validation of the feasibility and safety of AGS-004 treatment, and we look forward to presenting more detailed clinical data from the Phase 2 trial at a future medical meeting,” said Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development at Argos Therapeutics. “That the apheresis procedure was shown to be safe and well tolerated, as well as able to yield a large quantity of monocytes to generate the immunotherapy doses, also provides important validation for the Arcelis personalized immunotherapy manufacturing process.”

The first abstract, titled “Safety and Feasibility of a Multicentre Phase 2 Trial Using Autologous Dendritic Cell (DC) Therapy to Control Viral Replication Following ART Discontinuation,” details information from the Phase 2 trial of AGS-004, which was designed to assess its safety and effect on viral load when administered with anti-retroviral therapy (ART) following a well-controlled structured treatment interruption (STI). This trial was initiated to build on positive results from the Phase 1 trial, which demonstrated that AGS-004 induced immunogenicity in most patients. The treatment regimen in the Phase 2 trial consists of four intradermal doses, administered monthly in combination with ART. According to the data, few subjects experienced flu-like symptoms, gastrointestinal symptoms, fatigue or injection site reactions. No reports were made of clinical autoimmunity manifestations, detrimental changes in CD4 cell counts or viral blip.

The second abstract, titled “A Nursing Perspective of Apheresis Procedures Performed in HIV-infected Subjects Receiving a Monocytes-Derived Dendritic Cell-Based Immunotherapy,” provides a description of the AGS-004 apheresis procedure, data on its tolerability and safety, and practical information to further improve the efficacy of collection. This information was gathered from nurses in a large metropolitan teaching hospital who were involved with the AGS-004 Phase 2 trial. The apheresis procedure is a key step in generating the AGS-004 personalized immunotherapy, providing large quantities of the monocytes from which the dendritic cells are generated. Recruited subjects underwent two procedures – the first to generate the personalized immunotherapy product and the second to assess immune responses following the four intradermal injections.

According to the abstract, 28 total procedures were performed in 14 subjects, and each collection lasted approximately three to four hours. Results demonstrate that the procedures were well tolerated, with no serious side-effects and only six subjects experiencing post-procedure fatigue. Additionally, an average of 23 doses per subject was manufactured from each patient’s collection.

The first abstract was authored by: JP Routy1, S Vezina2, C Tremblay3, J Baril4, M Loutfy5, J Gill6, R Jain7, C Nicolette7, R Sekaly8 and MR Boulassel1 for the CTN 239 investigators. 1McGill University Health Centre, Montreal; 2Clinique médicale l'Actuel, Montreal; 3CHUM-Hotel Dieu de Montreal; 4Clinique Médicale du Quartier Latin, Montreal; 5Maple Leaf Clinic, Toronto; 6Southern Alberta Clinic, Calgary; 7Argos Therapeutics, Inc, Durham, NC; 8University of Montreal Research Centre, Montreal.

The second abstract was authored by: D Feng1, C Goupil1, J Mathieu1, M. Delisle1, S Girard 2, C Landry 3, C Gagné 4, M Swidzinski1, MR Boulassel1, JP Routy1 for the CTN-239 Study Investigators. 1Cell Separator Unit, Division of Hematology, McGill University Health Centre; 2Clinique l’Actuel; 3Centre Hospitalier de l’Université de Montréal, 4Clinique Quartier Latin, Montreal, Quebec, Canada.

The development of Argos’ Arcelis HIV immunotherapy program is part of the Company’s 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.

SOURCE: Argos Therapeutics

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