Enrollment In Argos Therapeutics' Pivotal Phase III ADAPT Trial of AGS-003 For Metastatic Renal Cell Carcinoma Surpasses Fifty Percent

Argos Therapeutics, Inc.

, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced it has recently surpassed fifty percent of the target enrollment for the company's ongoing pivotal Phase III ADAPT trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC). "This is an important milestone for the ADAPT trial as we continue to be pleased with the pace of enrollment and the opportunity to advance this promising, fully personalized immunotherapy in newly diagnosed, synchronous metastatic RCC patients," said Robert A. Figlin, MD, FACP, primary investigator for the ADAPT trial. "We remain encouraged by the potential for AGS-003 to represent an important advance for the immunotherapy field as well as the treatment of advanced RCC in the years ahead." AGS-003 is an investigational, fully personalized immunotherapy for cancer comprised of autologous tumor RNA-loaded dendritic cells. The ADAPT trial is a randomized, international Phase III trial comparing standard targeted therapy plus AGS-003 to standard therapy alone in 450 mRCC patients. In total, more than 225 patients at more than 120 active ADAPT trial sites have been enrolled and randomized in the trial. In addition, more than 600 patients have participated in the initial tumor collection phase of the trial. In the Company's completed Phase II study, treatment with AGS-003 in combination with sunitinib in unfavorable risk mRCC patients resulted in median progression free survival of 11.2 months and median overall survival of 30.2 months. In recently published findings from the International mRCC Database Consortium, unfavorable risk mRCC patients had an expected median progression free survival of 5.7 months and median overall survival of 14.7 months. For the patients with intermediate risk (1-2 risk factors) mRCC in the Company's Phase II study, treatment with AGS-003 in combination with sunitinib resulted in median overall survival of 57.1 months or nearly 5 years. Adverse events associated with the use of AGS-003 in the Phase II study were minor with no grade 3 or 4 adverse events and no evidence of autoimmunity.