Argos Therapeutics begins dosing patients in kidney cancer trial

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.

Approximately 26 patients with newly diagnosed, metastatic renal cell carcinoma will be enrolled in the phase I/II trial at multiple centers in the US and Canada. The primary objective of the trial is to measure T-cell responses to treatment with AGS-003.

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.

“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 Dr Lothar Finke, chief medical officer and vice president of regulatory affairs for Argos. “The successful demonstration of the safety and biologic activity of the product will provide clinical proof of concept for our unique personalized approach to cancer immunotherapy.”