Approximately 50 subjects with advanced renal cell carcinoma (RCC) will be enrolled in the Phase IIa 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’s broad collaboration with Kirin Pharma Company.
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.
John Bonfiglio, president and CEO of Argos, said: “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.
“We have initiated a Phase IIa proof-of-concept trial with AGS-004 in HIV, and recently reported positive immune response and safety data from the Phase I trial of AGS-004 in HIV. In addition, Argos expects to report data from our ongoing Phase II trial of AGS-003 as a single agent in RCC in 2009.”