Leveraging an antibody technology that could provide lupus patients with their first new therapy in 40 years, Argos Therapeutics Inc. entered an agreement potentially worth $69 million with Novo Nordisk A/S.

The Bagsvaerd, Denmark-based pharmaceutical company gains rights to the technology for systemic immune disorders, including systemic lupus erythematosus - a condition that affects as many as 1.5 million Americans.

Terms call for Durham, N.C.-based Argos to receive up to $69 million through an up-front payment and milestone payments. Royalties would be paid on sales.

Argos’ technology evolved from work done with researchers at the Baylor Institute for Immunology Research and through a grant from the Alliance for Lupus Research. The company identified specific monoclonal antibodies that target a molecule known to play a critical role in the onset and maintenance of systemic autoimmune disorders.

Since the technology is not part of Argos’ core focus, it had always "intended to add value to it by licensing it out," said Jeff Abbey, the company’s vice president of business development.

Founded in 1997 under the name Merix Bioscience, the company changed its name to Argos Therapeutics in September 2004. Its original focus was on RNA-based vaccine technology developed by its Duke University founders. In 2001, it acquired exclusive worldwide rights to complementary technology relating to the generation of dendritic cells from Rockefeller University.

Argos’ core programs "are all dendritic cell-based autologous immunotherapies," Abbey told BioWorld Today, adding that the company intends to move its lead program for kidney cancer into a second Phase I/II study this year. It also will begin clinical trials of its programs in chronic lymphocytic leukemia and in HIV. All are partnered in a 50/50 worldwide deal with Tokyo-based Kirin Brewery Inc.’s pharmaceutical division.

Dendritic cell (DC) research eventually led to findings that patients with SLE had profound alterations of DCs. Baylor researchers then learned that interferon-alpha is a cytokine that triggers the hyperactivation of the immune system cells in lupus patients and is a potential target for therapies to address the disease. Argos licensed the research from Baylor in 2001.

"We believe that we have hit upon the actual cause," Abbey said, "so we think that the treatment potentially could be a cure and could definitely make use of steroids obsolete for the treatment of lupus. But, obviously, we have a long way to go to prove that."

The company already has a lead candidate, a murine antibody that blocks interferon-alpha that could reach the clinic in 18 to 24 months, Abbey said, following humanization and manufacturing work by Novo.

Current therapies for lupus include corticosteroids, nonsteroidal immune suppressants, antimalarials and nonsteroidal anti-inflammatory drugs. The treatments are only partially effective and have side effects, such as bone thinning, weight gain, acne, anemia, sterility, rashes, diarrhea, hair loss and nausea.

SLE is an autoimmune disease in which the immune system attacks the body’s own tissues and organs, including joints, kidneys, heart, lungs and brain. No new drugs have been approved by the FDA in more than four decades.

Several companies have tried to bring new treatments to the market, but all have faced development challenges. Last year, for instance, San Diego-based La Jolla Pharmaceutical Co. laid off 60 employees after learning that its treatment for lupus-related renal disease, Riquent, was unlikely to get accelerated approval. The company received an approvable letter for Riquent in October 2004, but the FDA required completion of another study for final approval, delaying a potential launch until 2008. (See BioWorld Today, Oct. 18, 2004, and March 31, 2005.)

The company has not given up. In January, it announced plans to start a multidose study of Riquent in lupus patients this year. The trial should demonstrate the clinical benefit of the drug to delay time to renal flare.

Genelabs Technologies Inc., of Redwood City, Calif., also ran into trouble with its SLE product, Prestara, last year, when two studies failed to confirm results of the original 55-patient Phase III trial. The confirmatory study was required for the company to gain final approval of the drug, which received an FDA approvable letter in 2002. The company decided in January to conduct another Phase III trial but is seeking a partner to offset the costs. (See BioWorld Today, April 8, 2005, and Jan. 17, 2006.)

Abbey said he believed Argos’ technology has a well-established mechanism of action since all of the preclinical work done used serum from lupus patients.

Argos has a cGMP cell-processing facility and subsidiaries in Erlangen, Germany, and Amsterdam, the Netherlands. It has raised $53 million since inception, with its first round taking place in 2000.

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