Argos Therapeutics
Feb 15, 2018

Argos Announces Issuance of Patent Covering the Foundation for Manufacturing its HIV Immunotherapy

Patent Related to Strain-Independent Amplification of HIV Nucleic Acid Sequences

DURHAM, N.C., Feb. 15, 2018 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced the issuance of U.S. patent 9,879,053, covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations.

The methods described in this patent form the foundation for the manufacture of AGS-004, Argos' novel, dendritic cell-based immunotherapy for HIV. AGS-004 consists of autologous dendritic cells electroporated with amplified virus RNA and CD40L RNA that are designed to stimulate T cells to attack HIV-infected cells. Because HIV has a high mutation rate, viral variants are different in each patient. The methods described in this patent are used to amplify RNA encoding the unique viral variants in an individual from a small amount of blood or infectious plasma from which the virus can be isolated. This allows the generation of immunotherapies that are matched to the unique pathogen mutations in a specific individual, thus facilitating the development of a customized immunotherapy that may be more effective at controlling or eliminating the pathogen. The claims in this patent are directed to AGS-004, methods of manufacturing AGS-004 and methods of treatment utilizing AGS-004.

AGS-004 is currently being evaluated in an investigator sponsored Phase 2 clinical trial in combination with the latency-reversing agent vorinostat under the direction of David Margolis, M.D., Professor of Medicine, Division of Infectious Diseases, and Director of the HIV Cure Center at the University of North Carolina. The latent viral reservoir consists of infected immune cells in which the HIV virus is dormant and therefore hidden from attack by the immune system. Largely because of the latent viral reservoir, currently available agents for the treatment of HIV, while able to limit the proliferation of the HIV virus, have not been successful in eradicating the virus and thus curing HIV. The trial is designed to test the hypothesis that boosting antiviral immunity with AGS-004 combined with a latency reversing drug to expose the virus in latently infected cells to the immune system may enable eradication of the virus.

"We believe that our ability to customize the immune response to patients' unique viral variants, particularly to those variants persisting in the latent viral reservoir, offers a scientifically compelling rationale for this study," noted Irina Tcherepanova, Ph.D., vice president of translational medicine, Argos Therapeutics. Initial data from the ongoing clinical trial is expected during the second half of 2018.

About Argos Therapeutics

Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, Rocapuldencel-T, 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 combination with vorinostat, a latency-reversing drug, in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Funding for the development of AGS-004 has been provided by the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Collaboratory of Research for AIDS Eradication.

Forward Looking Statements

Any statements in this press release about Argos' future expectations, plans and prospects, including statements about the clinical development of Argos' product candidates, 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 the patents and patent applications owned or licensed by the Company, such as the patent referred to in this release, will protect the Company's technology and prevent others from infringing it; whether Argos' cash resources will be sufficient to fund its continuing operations for the period anticipated; whether preliminary or interim clinical data will be indicative of the final data from a clinical trial; whether results obtained in preclinical studies or early 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; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos' Form 10-Q for the quarter ended September 30, 2017, 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.

Investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.

Media Contact:
Adam Daley
Berry & Company Public Relations