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Argos Therapeutics Validates Durability of AGS-003 Induced Immune Response in mRCC Patients

DURHAM, N.C., March 4, 2013 (GLOBE NEWSWIRE) -- 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 validated the durability of the immune response for metastatic renal cell carcinoma (mRCC) patients treated with AGS-003. Additionally, the Company confirmed the correlation between specific immune markers and overall survival in these patients is statistically significant. The data from these studies will be presented during two poster sessions at Keystone Symposia's Understanding Dendritic Cell Biology to Advanced Diseases Therapies Conference on March 3-8 in Keystone, Colorado.

Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos, stated, "The validated durability of the immune response to AGS-003, and the established correlation between certain immune markers and overall patient survival, helps to characterize with further specificity the updated overall survival data from our Phase 2 trial, which we presented at this year's Genitourinary Cancers Symposium. The data we are presenting at the Keystone Symposia confirms the accuracy of the Phase 2 results and the importance of the ADAPT Phase 3 clinical trial."

The two posters are entitled "Autologus Dendritic Cell Therapy AGS-003, Induces Strong Durable Immune Responses in Patients with Advanced Renal Cell Carcinoma" and "Multi-Functional Cytotoxic T-Cell Subsets as Immune Correlates with Clinical Outcomes in a Phase II Study of AGS-003, an Autologous Dendritic Cell-Based Therapy Administered To Newly Diagnosed, Metastatic RCC Patients." The latter demonstrates that a specific tumor-reactive cytotoxic T-cell (CTL) subset (CD28+/CCR7+/CD45RA-) displaying a broad Markers of Immune Function (MIFs) profile correlates with long-term overall survival in patients treated with AGS-003. The former outlines that one patient treated long-term with AGS-003, with greater than 30 months overall survival, maintained the presence of CD28+/CCR7+/CD45RA- CTLs outwards to 3 years post initial treatment.

To further evaluate and validate the potential clinical and immunologic effects of AGS-003, Argos Therapeutics is currently enrolling patients in the ADAPT Phase 3 clinical study for AGS-003. The ADAPT study is a randomized, multicenter, open-label clinical trial expected to enroll 450 patients in approximately 120 global sites, mostly in North America, under an approved Special Protocol Assessment by the Food and Drug Administration. The study is designed to examine the potential for AGS-003 plus standard targeted drug therapy to extend overall survival versus standard therapy alone in newly diagnosed patients with unfavorable risk mRCC.

For more information about AGS-003 and the ADAPT study, visit www.ADAPTkidneycancer.com, or follow us on Twitter @ADAPTkdnycancer.

About the Arcelis™ Technology Platform

Arcelis is a fully personalized, active immunotherapy technology that captures all antigens, including mutated and variant antigens that are specific to each patient's disease. It has been shown to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that are associated with toxicity. The technology can be leveraged to manufacture personalized therapies for any cancer or infectious disease.

The Arcelis process integrates readily into many current treatment paradigms, using only a small tumor or blood sample and the patient's own dendritic cells, which are derived and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient sample to program the dendritic cells to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered as an intradermal injection to produce the desired patient-specific immune response.

Arcelis technology also overcomes many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. Automated processes allow a single facility to serve all of North America and can be used to treat any cancer or infectious disease with the same manufacturing process and equipment.

About Argos Therapeutics

Argos Therapeutics is 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. Argos´ most advanced product candidate AGS-003 has initiated a Phase 3 study for the treatment of mRCC, and the Company plans to have data from its Phase 2b study of AGS-004 for the treatment of HIV in the second half of 2013. Argos also recently completed a successful Phase 1a study of AGS-009 in patients with lupus. For more information about Argos Therapeutics, visit www.argostherapeutics.com.

Source: Argos Therapeutics

*Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma

CONTACT: The Ruth Group Caitlin Cox(media) ccox@theruthgroup.com (646) 536-7033 Nicole Greenbaum(investors) ngreenbaum@theruthgroup.com (646) 536-7009 Argos Therapeutics Jeff Abbey(partners) jabbey@argostherapeutics.com (919) 287-6308Source: Argos Therapeutics