Argos Therapeutics Announces First Patient Dosed in Stage 2 of Adult Eradication Trial of AGS-004 in the Treatment of HIV

The investigator-initiated Phase 2 trial is designed to evaluate the virologic impact of the combination of the latency-reversing drug, vorinostat, and AGS-004, the company’s investigational immunotherapy based on the Arcelis® technology platform.

DURHAM, N.C., July 14, 2016 (GLOBE NEWSWIRE) — Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced that the first patient has been dosed in the second stage of the ongoing investigator-initiated Phase 2 adult eradication clinical trial of AGS-004, the company’s investigational immunotherapy for the treatment of human immunodeficiency virus (HIV) infection, in combination with the latency-reversing drug, vorinostat. This second stage study, being funded by a federal research grant from the Division of AIDS of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, is being conducted at the University of North Carolina, Chapel Hill.

Eliminating the latent virus reservoir is an essential treatment goal in efforts to eradicate HIV infection. Research has shown that histone deacetylase (HDAC) inhibitors, like vorinostat, can reverse latency by activating latently infected cells, potentially allowing them to then be targeted by the immune system.

This is the first clinical trial evaluating the “kick and kill” approach employing a validated HIV latency-reversing drug combined with an individualized immunotherapy. In the trial, HIV-infected patients are being given latency-reversing therapy with the HDAC inhibitor vorinostat in combination with the immunotherapy, AGS-004. “This study will test whether combining AGS-004 treatment with a latent virus reservoir mobilizer can lead to the elimination of HIV-infected cells,” stated Dr. David Margolis of the University of North Carolina, director of the UNC HIV Cure center.   

The study is expected to evaluate 12 participants who will receive alternating courses of the two agents. Throughout the study, CD8+ T cell responses will be measured along with changes in low level plasma HIV-1 RNA and the frequency of HIV-1 infection of resting CD4+ T cells. All participants will continue antiretroviral therapy (ART) throughout the study.

“We believe that AGS-004 is a preferred immunotherapy to pair with latency-reversing therapy since it directs immune responses against each patient’s own unique viral species antigens expected to emerge from latency,” said Charles Nicolette, PhD, chief scientific officer of Argos. “We have previously demonstrated in clinical trials that AGS-004 has induced antiviral memory T cell responses in HIV-infected patients, and in this study we hope to see a decrease in the amount of latent HIV infection in resting CD4+ cells.”

About the Arcelis® Technology Platform
Arcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of 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 immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by 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. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer and infectious diseases 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). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients.

Forward Looking Statements
Any statements in this press release about Argos’ future expectations, plans and prospects, including statements about the expected and potential future closings of the private placement, Argos’ financial prospects, anticipated use of proceeds, future operations and sufficiency of funds for future operations, clinical development of Argos’ product candidates, expectations regarding future clinical trials and future expectations and plans and prospects for Argos and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” 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 such forward-looking statements as a result of various important factors, including whether Argos’ cash resources will be sufficient to fund its continuing operations for the periods 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; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos’ product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Argos’ Form 10-Q for the quarter ended March 31, 2016, which is on file with the SEC,  and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos’ views as of the date hereof. 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 the date hereof.

CONTACT: Media contact: 
Adam Daley 
Berry & Company Public Relations

Investor contact:
John Menditto
Argos Therapeutics, Inc.