Argos Therapeutics announced the initiation of a Phase 2a trial of its AGS-003 therapy, in combination with sunitinib, for the treatment of newly diagnosed advanced renal cell carcinoma (RCC). AGS-003 is a product of the Company's Arcelis™ technology, which is an immunotherapy platform for creating personalized, RNA-loaded, dendritic cell-based therapies perfectly matched to each patient's unique tumor burden. In vitro and animal model studies of the impact of sunitinib on the function of dendritic cells and T-cells have indicated evidence of synergistic activity. The aim of the current trial is to confirm these results in a clinical setting.

"There is a true unmet need for treatment options for advanced RCC, as nephrectomy plus high dose interleukin (IL) 2 remains the only treatment associated with long-term complete responses for this condition. However, toxicities associated with this treatment make it available to only a very select group of patients," said Theodore Logan, M.D., of the Indiana University Cancer Center.

"Prior clinical studies of AGS-003 alone in RCC have demonstrated its favorable safety profile compared to high-dose IL-2 and other therapies available for the treatment of RCC," said Lothar Finke, M.D., Chief Medical Officer of Argos. "We therefore believe that combining a personalized immunotherapy, such as AGS-003, with conventional pharmaceutical treatment for RCC may result in a better tolerability profile, potentially providing treatment to a broader patient population. This combination approach may expand antitumor immunity and reduce overall tumor burden and may lead to improved clinical outcomes compared to use of either treatment by itself. Additionally, because our Arcelis technology creates an individualized immunotherapy that is perfectly matched to each patient's cancer, we believe our approach offers advantages over other cancer immunotherapy approaches."

"This trial initiation further displays significant progress in advancing our Arcelis personalized immunotherapy platform and demonstrates the broad potential of our therapies for not only stand-alone treatment, but also in a combination therapy regimen with currently marketed drugs," said John Bonfiglio, Ph.D., President and CEO of Argos. "We have initiated a Phase 2a proof-of-concept trial with AGS-004 in HIV, and recently reported positive immune response and safety data from the Phase 1 trial of AGS-004 in HIV. In addition, Argos expects to report data from our ongoing Phase 2 trial of AGS-003 as a single agent in RCC in 2009."

About the AGS-003 Phase 2 Trial in RCC

Approximately 50 subjects with advanced RCC will be enrolled in the Phase 2 trial. The study will be conducted at up to 15 sites in North America. The primary study objective is to evaluate clinical activity of AGS-003 in combination with sunitinib, as defined by RECIST criteria. Secondary objectives include monitoring the immune response to treatment, and assessing safety. The development of AGS-003 is part of Argos' broad collaboration with Kirin Pharma Company, Ltd.

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.

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.

Argos Therapeutics, Inc.