Argos Therapeutics Initiates Phase I/II Trial with AGS-003 Personalized Immunotherapy in Advanced Kidney Cancer
Trial to Evaluate New Production Process That May Yield More Potent Immune Response
August 17 2006 – DURHAM, N.C. - Argos Therapeutics today announced that dosing has been initiated in a Phase I/II clinical trial to test the activity and safety of AGS-003, a personalized immunotherapy for advanced kidney cancer (metastatic renal cell carcinoma). AGS-003 is a second-generation dendritic cell-based therapy with optimized immune response characteristics that is designed to stimulate the patient's immune system to target and destroy the patient's cancer cells.
"The second clinical trial of AGS-003 in advanced renal cell carcinoma builds on the positive safety and activity results of our previous Phase I/II trial. In the current trial we are using an improved, second-generation AGS-003 to stimulate an enhanced immune response," said Lothar Finke, M.D., Chief Medical Officer and Vice President of Regulatory Affairs for Argos. "The successful demonstration of the safety and biologic activity of the product, in addition to showing the feasibility to produce and supply this individualized immunotherapy in a timely manner, will provide clinical proof of concept for our unique personalized approach to cancer immunotherapy. Furthermore, the results of this trial will provide guidance for future controlled clinical studies."
"We look forward to seeing clinical data with this new formulation of AGS-003," Finke continued. "Pre-clinical data suggests that the therapy produces dendritic cells that are highly efficient at generating a specialized subset of cytotoxic (killer) T cells capable of continuous expansion as long as the tumor antigens remain. In our previous clinical trial no drug-related major toxicity, including autoimmune toxicity, was observed. Importantly, in that trial, the safety profile of first-generation AGS-003 compared favorably to conventional chemotherapeutic agents and to high dose IL-2, which is currently the only curative drug for advanced kidney cancer."
"Metastatic renal cell carcinoma is a devastating disease with a poor prognosis for survival. There is still a dire unmet medical need for curative options that has unfortunately not been changed by recently approved therapies," stated Dr. Ted Logan, of Indiana University Cancer Center. "Dendritic cell-based immunotherapy is a very promising approach; previous studies have demonstrated that using a patient's dendritic cells loaded with that individual's specific tumor RNA can lead to a primary immune response. I look forward to seeing whether the improved process used to manufacture AGS-003 will lead to an even stronger 'killer' T-cell response potent enough to target and destroy tumors."
About the AGS-003 Phase I/II Trial
Approximately 26 patients with newly diagnosed, metastatic renal cell carcinoma will be enrolled in the Phase I/II trial at multiple centers in the United States and Canada. The primary objective of the trial is to measure T-cell responses to treatment with the AGS-003 immunotherapeutic. Secondary trial objectives include safety assessments and confirming the feasibility of using a new manufacturing process, which may enhance production efficiency as well as the strength of the immune response induced by AGS-003. The trial will also measure clinical antitumor activity, progression-free survival, and overall survival.
RNA-loaded Dendritic Cell Technology
Argos's proprietary approach to personalized cancer immunotherapy is based on optimizing a patient's own (autologous) dendritic cells to trigger a tumor-specific immune response. To address the challenge of the unique genetic profile of each patient's cancer and the genetic mutations of that cancer, Argos loads the autologous dendritic cells with a patient's total tumor RNA. Through this process, dendritic cells are enabled to recognize the complete antigenic repertoire of a particular patient's tumor, resulting in an immunotherapy personalized for a patient's specific disease.
About Argos Therapeutics, Inc.
Argos Therapeutics is developing breakthrough immunotherapies that target the unique features of a patient's disease. This new generation of personalized cancer and HIV therapeutics trains the immune system to recognize and attack the disease. Argos' scientific leadership in RNAloaded dendritic cells and advanced manufacturing processes provide a platform to tackle virtually all forms of cancers and infectious diseases. www.argostherapeutics.com
Argos is a private biotechnology company headquartered in Research Triangle Park, NC. The company has multiple clinical trial programs in renal cell carcinoma (RCC), chronic lymphocytic leukemia (CLL), and human immunodeficiency virus (HIV) and has an ongoing co-development and commercialization alliance with the pharmaceutical division of Kirin Brewery Company, Limited.