Argos Therapeutics Presents Positive Data on its Personalized Cancer Immunotherapy Programs at ISTBC Meeting

DURHAM, N.C.--(BUSINESS WIRE)--Nov 1, 2007 - Argos Therapeutics today announced the presentation of two abstracts related to its personalized dendritic cell-based immunotherapy programs at the 22nd Annual Meeting of the International Society for the Biological Treatment of Cancer (iSTBc), held November 2-4 in Boston. Results from the presented abstracts reveal that Argos' immunotherapeutic candidate AGS-003 is compatible in combination with sunitinib (Sutent(R)) for the treatment of renal cell carcinoma (RCC). Argos researchers also will present pre-clinical data demonstrating that the Company's proprietary process for the optimization of dendritic cells, called Arcelis, is capable of inducing a strong and robust immune response appropriate for the treatment of cancer, and that this approach may be superior to other currently used processes.

In a poster presentation included in a workshop on combination therapy for cancer, Don Healey, Ph.D., Director of Immunology at Argos, will discuss a study investigating the combination of Argos' dendritic cell immunotherapy with two marketed tyrosine kinase inhibitors (TKI), sorafenib (Nexavar(R)) and Sutent, for the treatment of RCC. Researchers were primarily interested in the TKIs' effects on the production of dendritic cells ex vivo, as well as their impact on in vitro induced T-cell responses. Apheresis products from healthy volunteers were spiked with Nexavar or Sutent for two hours prior to the ex vivo generation of dendritic cells, and apheresis products were also collected from RCC patients undergoing Sutent therapy. Researchers measured dendritic cell yield as well as immunopotency. While neither TKI impaired dendritic cell generation, Nexavar blocked T-cell expansion when used in combination with Argos' immunotherapy, revealing that this drug combination may result in a less potent immune response. However, Sutent was not found to block T-cell expansion.

"The findings from this study support our ongoing strategy for AGS-003 in RCC, as we have planned a Phase 2 trial in combination with Sutent to begin in early 2008," said John Bonfiglio, Ph.D., President and CEO of Argos. "We also believe that this potential synergy with Sutent demonstrates the broad potential for our immunotherapy candidates to be used not only as a stand-alone treatment, but also in a combination therapy regimen with currently marketed drugs."

A second presentation by Dr. Healey will highlight Argos' proprietary dendritic cell optimization process, Arcelis, which involves co-loading post-maturation electroporated (PME) dendritic cells with CD40L RNA and tumor antigen RNA. According to pre-clinical results, these PME-CD40L dendritic cells drive stronger effector memory in cytotoxic T-lymphocytes (CTLs) in comparison to mature dendritic cells generated with cytokines alone, making them better able to recognize cancer antigens. In a pre-clinical model system, the Arcelis process induced the expansion of MART-1 (a cancer protein antigen used as a tumor marker) positive CTLs that were able to kill antigen-presenting targets and cell lines from specific cancer types. These long lived effector memory CTLs are better able to recognize cancer antigens; produce high levels of interferon-y and interleukin-2, which assist the immune response; and identify limiting quantities of antigens, leading to cancer cell destruction.

"In order to be effective, dendritic cell-based immunotherapeutics must be able to induce robust cytotoxic T cells capable of killing tumor cells in vivo," commented Dr. Healey. "Argos' process for optimizing dendritic cells is capable of inducing a complex cascade of signals that generate a faster and stronger immune response. We believe that this data validates the feasibility of the Arcelis approach for in vivo cancer immunotherapy and also indicates that our optimization method is superior in driving strong effector memory CTLs when compared to other methods currently used."

The first abstract, titled "Sorafenib but not Sunitinib Inhibits Human T-cell Function In Vitro: Implications for Combined TKI and Immunotherapy Strategies for the Treatment of Cancer," was authored by Don Healey; David Calderhead, Alicia Gamble, Helen Ketteringham, Lothar Finke, Charles Nicolette, and Mark DeBenedette, of Argos Therapeutics; Robert Figlin of City of Hope National Medical Center; and Harry Drabkin of Medical University of South Carolina.

The second abstract, titled "PME-CD40L DC Prime the Expansion of CD28+/CD45RA- Long Lived Effector Memory CTL Having Clinical Relevance for Dendritic Cell Immunotherapies," was authored by Don Healey, David Calderhead, Alicia Gamble, Joe Horvatinovich, Helen Ketteringham, Melissa Adams, Brad Lackford, Irina Tcherepanova, Charles Nicolette and Mark DeBenedette, of Argos Therapeutics.

About Argos Therapeutics, Inc.

Argos Therapeutics is developing breakthrough immunotherapies that target the unique features of a patient's disease. This new generation of personalized cancer and infectious disease therapeutics, created using the Company's "Arcelis" technology, trains the immune system to recognize and attack the disease. Argos' scientific leadership in RNA-loaded dendritic cells and advanced manufacturing processes provide a platform to tackle virtually all forms of cancers and infectious diseases. www.argostherapeutics.com

Argos is a private biotechnology company headquartered in Research Triangle Park, NC. The Company has clinical trial programs in cancer and human immunodeficiency virus (HIV) and has an ongoing co-development and commercialization alliance with the Pharmaceutical Division of Kirin Brewery Company, Limited.

Sutent(R) is a registered trademark of Pfizer.

Nexavar(R) is a registered trademark of Bayer Pharmaceuticals and Onyx Pharmaceuticals.

Contact

MacDougall Biomedical Communications
Jennifer Greenleaf, 508-647-0209
or
Argos Therapeutics
Jeff Abbey, 919-287-6308

Posted: November 2007

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