NIH Funds Study of Fully Personalized Immunotherapy AGS-004 Combined With a Latency Reversing Therapy for the Treatment of HIV

NIH Division of AIDS Approves $6.6 Million to Fund Investigator-Initiated Phase 2a Adult Eradication Study

Durham, North Carolina, UNITED STATES

DURHAM, N.C., April 1, 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 and infectious diseases based on the Arcelis® technology platform, today announced that the NIH Division of AIDS (DAIDS) has approved $6.6 million in funding for an investigator-initiated Phase 2a adult eradication study of AGS-004, the company's investigational fully personalized immunotherapy for HIV.

Eliminating the latent virus reservoir has been shown to be an essential goal in efforts to eradicate HIV. Research has shown that histone deacetylase (HDAC) inhibitors can activate cells that are latently infected with HIV, making them more visible to the immune system. One strategy to achieve HIV eradication is known as the "kick and kill" approach where a latency reversing therapy such as an HDAC inhibitor is combined with an immunotherapy to maximize the immune system's response to the latent reservoir in an effort to eliminate it.

"Previous study results suggest AGS-004 can induce anti-viral memory T-cell responses that are associated with lower persistent viral reservoirs when administered in combination with standard antiretroviral therapy (ART)," said Dr. Charles Nicolette, Argos' chief scientific officer and vice president of research and development. "The continued support of DAIDS allows us to move forward with stage two of our adult eradication trial, which has already been cleared for initiation by the FDA. We believe that this is the first human clinical trial to test the highly promising 'kick and kill' approach to treatment."

"With this NIH funding, we can now study whether combining AGS-004 treatment with a latent reservoir mobilizer can lead to the elimination of HIV-infected cells," stated Dr. David Margolis of the University of North Carolina, principal investigator of the AGS-004 Phase 2a adult eradication study. "In stage two of this study, patients on ART will receive the HDAC inhibitor vorinostat in addition to AGS-004."

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 infectious diseases, 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

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' Quarterly Report on Form 10-Q for the quarter ended September 30, 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 1, 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 1, 2015.


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