DURHAM, N.C. – February 13, 2013 – 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 updated results from its Phase 2 study of AGS-003, its most advanced product candidate for the treatment of metastatic renal cell carcinoma (mRCC). The results, which will be presented by Dr. Asim Amin of the Levine Cancer Institute during a poster session on Saturday February 16, at the 2013 ASCO Genitourinary Cancers Symposium in Orlando, continue to show prolonged survival in patients with unfavorable risk mRCC, with one-third of patients still alive after nearly four years or longer.
Jeff Abbey, Chief Executive Officer of Argos Therapeutics, stated, “The prolonged survival of patients in our Phase 2 study is striking and directly correlates to the immune responses generated by AGS-003. The combination of AGS-003 plus sunitinib doubled the expected overall survival for the unfavorable risk advanced kidney cancer patients enrolled in the study and one-third of the patients remain alive after nearly four years or longer. We are confident these encouraging clinical and immunological responses will be further validated in our ongoing pivotal Phase 3 ADAPT study.”
The open label Phase 2 study followed 21 patients with unfavorable risk mRCC, with an expected survival of approximately fifteen months. Treatment consisted of standard 6-week cycles of sunitinib plus AGS-003, which was administered every three weeks for five doses, and then every 12 weeks until progression.
As previously reported, the final median overall survival was 30.2 months. When analyzed by baseline Heng risk status, the median overall survival for intermediate risk patients (n=11) has not been reached, but is estimated to be longer than 39.5 months with continued follow-up. Median overall survival for poor risk patients (n=10) was 9.1 months. Of the 21 patients who participated in the study, seven (33%) patients are still alive after nearly four years or longer following study registration.
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 and is expected to enroll 450 patients in approximately 120 global sites, mostly in North America. 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. Secondary endpoints include progression-free survival, safety, overall response and immune response.
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.