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Independent Data Monitoring Committee Recommends Continuation of Pivotal ADAPT Phase 3 Clinical Trial of AGS-003 for Metastatic Renal Cell Carcinoma

DURHAM, N.C., June 4, 2015 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced an independent data monitoring committee (IDMC) has recommended the continuation of the company's pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) following the first of three planned interim data analyses.

The IDMC recommendation coincided with an update on enrollment in the ADAPT trial presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting by principal investigator 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. In a poster presentation titled "Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience" (abstract TPS4582), Dr. Figlin noted more than 1,000 tumor samples have been collected and approximately 400 patients have been randomized to the treatment phase of the study thus far.

"We are very pleased with the progress of the ADAPT phase 3 trial to evaluate AGS-003, which is generating great interest within the advanced kidney cancer community," said Dr. Figlin. "We look forward to further IDMC reviews and interim data readouts as we advance the largest global trial ever performed in the newly diagnosed, unfavorable risk mRCC patient population."

AGS-003 is an autologous dendritic-cell based immunotherapy designed to induce a memory T-cell response specific to a patient's tumor antigens. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable risk mRCC patients. The randomized phase 3 ADAPT study evaluating standard targeted therapy plus AGS-003 is designed to enroll about 450 mRCC patients in total.

"We are on the cusp of a very important and exciting period in the development of AGS-003," said Mr. Jeffrey D. Abbey, president and chief executive officer of Argos. "We welcome the IDMC recommendation to continue our pivotal ADAPT trial and are in position to complete patient enrollment this summer as planned."

Conference Call and Webcast Details

Argos executive management will host a conference call with Dr. Figlin beginning at 4:30pm EDT on Monday June 8, 2015 to discuss the ADAPT trial update presented at ASCO, the IDMC recommendation to continue the trial, and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 61247434. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.argostherapeutics.com. The archived webcast will remain available on the Company's website for 14 days following the call.

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 an immuno-oncology 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 aimed at HIV eradication in adult patients. For more information about Argos Therapeutics, visit www.argostherapeutics.com.

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 June 4, 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 June 4, 2015.

CONTACT: Media contact: Adam Daley Berry & Company Public Relations 212-253-8881 adaley@berrypr.com Investor contact: Carol Werther Burns McClellan 212-213-0006 cwerther@burnsmc.com

Source:Argos Therapeutics, Inc.