Argos Therapeutics
Apr 21, 2015
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Argos Therapeutics Announces Publication of Data From Phase 2 Clinical Trial of AGS-003 Fully Personalized Immunotherapy for Treatment of Metastatic Renal Cell Carcinoma (mRCC)

Encouraging Survival With the Combination of AGS-003 Plus Sunitinib in Unfavorable Risk mRCC Published in Journal for ImmunoTherapy of Cancer

DURHAM, N.C., April 21, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that data from a Phase 2 clinical trial of AGS-003, the company's lead product candidate for the treatment of metastatic renal cell carcinoma (mRCC), have been published in the Journal for ImmunoTherapy of Cancer. The study findings show that treatment with AGS-003 in combination with sunitinib was safe, well tolerated and associated with immunologic responses and extended survival.

AGS-003 is an autologous immunotherapy that is prepared using a patient's own dendritic cells and amplified tumor RNA. In the multicenter Phase 2 trial led by Dr. Asim Amin, medical oncologist at the Levine Cancer Institute, encouraging median overall survival of 30.2 months was observed for all patients treated with the combination of AGS-003 plus sunitinib. According to the International mRCC Database Consortium, similar unfavorable risk mRCC patients have an expected overall survival of 14.7 months. In addition, in the Phase 2 trial, patients with intermediate risk experienced a median survival in excess of 5 years. Data presented during the 2014 ASCO Genitourinary Cancers Symposium by Dr. Avishay Sella, head of the Department of Oncology at Asaf Harofeh Medical Center in Israel, indicate the expected median survival for intermediate risk mRCC patients treated with sunitinib as their first line targeted therapy is approximately 20.5 months.

"In comparison to the benchmarks established for similar risk mRCC patients treated with targeted therapy, the outcomes in this study were encouraging," said Dr. Amin. "Mature data from this Phase 2 study suggest the combination of AGS-003 plus sunitinib was safe, well tolerated and associated with doubling of the expected median survival and encouraging long-term and 5-year survival."

"AGS-003 is designed to generate a patient and tumor-specific immune response," said study co-author Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology and professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute. "Observations from this study indicate that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival. These important findings are being further evaluated in the ongoing Phase 3 ADAPT study."

"We are encouraged by the overall and long-term survival outcomes in this intermediate and poor risk mRCC population," said Doug Plessinger, vice president of clinical and medical affairs of Argos. "We are working aggressively to advance the development of AGS-003 with our ongoing pivotal Phase 3 ADAPT study which is expected to complete enrollment of 450 mRCC patients in mid-2015. We also plan to advance studies of AGS-003 in earlier stages of renal cell carcinoma and other solid tumors later this year."

The Journal for ImmunoTherapy of Cancer paper is titled, "Survival with AGS-003, an autologous dendritic cell-based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results."

About the Arcelis® Technology Platform

Arcelis® is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient's disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis® process uses only a small tumor or blood sample and the patient's own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.

About Argos Therapeutics

Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform. Argos' most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). The Company is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of HIV, currently being evaluated in a phase 2 clinical trial in combination with a latency reversing drug for HIV eradication in adult patients. For more information about Argos Therapeutics, visit

About the Journal for ImmunoTherapy of Cancer

The Journal for ImmunoTherapy of Cancer (JITC) is the official journal of the Society for Immunotherapy of Cancer (SITC). This open access, peer-reviewed journal not only serves as the global voice of the Society, but also a targeted outlet for the publication of original research articles, literature reviews, position papers and discussion on all aspects of tumor immunology and cancer immunotherapy—from basic research to clinical application. For more information, visit

Forward Looking Statements

Any statements in this press release about Argos' future expectations, plans and prospects, including statements about Argos and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund our continuing operations for the period anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Argos' Annual Report on Form 10-K for the year ended December 31, 2014 which is on file with the SEC. In addition, the forward-looking statements included in this press release represent Argos' views as of April 21, 2015. Argos anticipates that subsequent events and developments will cause Argos' views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos' views as of any date subsequent to April 21, 2015.

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