AGS-003

Drug Overview

AGS-003 (Argos Therapeutics/Kyowa Hakko Kirin) is a cancer vaccine in development for the first-line treatment of metastatic renal cell cancer (RCC) in combination with Sutent (sunitinib; Pfizer). AGS-003 contains autologous dendritic cells which are transfected with patient-specific RNA and synthetic human CD40 ligand (CD40L) RNA. Upon treatment, AGS-003 may elicit a specific T-cell response against RCC cells expressing patient-specific tumor-associated antigens. This signal cascade may result in the secretion of the inflammatory cytokine interleukin-12.

Analyst Outlook

Argos Therapeutics/Kyowa Hakko Kirin are positioning AGS-003 in combination with Sutent (sunitinib; Pfizer) as a first-line therapy for patients with metastatic renal cell cancer (mRCC). The company will have to provide evidence that addition of the vaccine to Sutent monotherapy is of significant clinical benefit to patients, in order to justify its complex manufacturing process and associated high cost. AGS-003 has shown efficacy in untreated mRCC patients when used in combination with Sutent in early-phase clinical trials. Datamonitor Healthcare believes that efficacious results versus Sutent in pivotal Phase III trials will result in market approval of AGS-003 in the first-line setting; however, uptake may be dampened by the high cost of therapy.