Argos Therapeutics Identifies Immune Response Marker Connected to Prolonged Overall Survival in mRCC Patients Treated With AGS-003

DURHAM, N.C., Oct. 11, 2012 (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 that it has identified a unique immune response signature that significantly correlates with clinical outcomes associated with its Arcelis™ immunotherapy product candidate, AGS-003 being developed for the treatment of metastatic renal cell carcinoma (mRCC). Data presented at the Markers in Cancer Meeting, October 11, Hollywood, Fla., demonstrates that a specific tumor-reactive cytotoxic T cell (CTL) subset (CD28+/CCR7+/CD45RA- phenotype) displaying a broad Markers of Immune Function (MIFs) profile correlates with progression-free survival (PFS) and overall survival (OS) in patients treated with AGS-003.

Mark DeBenedette Ph.D., Director Immunology, Argos Therapeutics, and lead author, said, "These data revealed statistically relevant correlations between patients treated with AGS-003 who experienced longer overall survival and the presence of central memory cytotoxic T-cells specific to RCC tumor antigens. This broad functional response is central to the intended mechanism of action of AGS-003 in RCC patients' receiving immunotherapy."

The poster presentation titled, "Identification of 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," outlined the bioinformatics approach used to analyze immune response data generated from AGS-003-006, an open label Phase 2 trial of AGS-003 in combination with sunitinib in patients with newly diagnosed, unfavorable-risk, metastatic clear cell (RCC ). This is the first time such a bioinformatics approach, which is more commonly applied to gene microarray data, has been applied to data generated from multi-parametric flow cytometry examining cytotoxic T cell responses in patients receiving immunotherapy.

To further evaluate and validate the potential clinical and immunologic effects of AGS-003 in advanced RCC, the ADAPT Phase 3 study has been initiated under a special protocol assessment (SPA) with the Food and Drug Administration (FDA) and enrollment is expected to begin late 2012. The pivotal trial is a 2:1 randomized, multicenter, open-label study of AGS-003 in combination with standard targeted therapy, beginning with sunitinib, compared to targeted therapy alone in newly diagnosed mRCC patients. A total of 450 patients will be enrolled at approximately 100 sites globally. The study´s primary endpoint is overall survival (OS). Additional endpoints will include overall response, immune response, progression-free survival (PFS) and safety.

About the Arcelis™ Technology

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 injection into the skin to produce the desired patient-specific immune response.

Arcelis technology also overcomes many of the manufacturing and commercialization challenges that have impeded other 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.

CONTACT: The Ruth Group Victoria Aguiar (media) (646) 536-7013 Nicole Greenbaum (investors) (646) 536-7009 Argos Therapeutics Jeff Abbey (partners) (919) 287-6308Source: Argos Therapeutics