Argos Therapeutics Announces Updated Phase II Data

Argos Therapeutics Inc. recently announced updated results from its Phase II study of AGS-003, its most advanced product candidate for the treatment of metastatic renal cell carcinoma (mRCC). The results, which were 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 4 years or longer.

“The prolonged survival of patients in our Phase II study is striking and directly correlates to the immune responses generated by AGS-003,” said Jeff Abbey, Chief Executive Officer of Argos Therapeutics. “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 4 years or longer. We are confident these encouraging clinical and immunological responses will be further validated in our ongoing pivotal Phase III ADAPT study.”

The open label Phase II study followed 21 patients with unfavorable risk mRCC, with an expected survival of approximately 15 months. Treatment consisted of standard 6-week cycles of sunitinib plus AGS-003, which was administered every 3 weeks for 5 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, 7 (33%) patients are still alive after nearly 4 years or longer following study registration.

Argos Therapeutics is currently enrolling patients in the ADAPT Phase III 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.

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.

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