Monday, June 11, 2012

Experimental Lupus Treatment from Argos Therapeutics Shows Promise in Clinical Trials

The experimental lupus treatment being developed by Durham-based CED Member Argos Therapeutics is showing promise in early stage clinical trials, but the questions remain whether it’s enough progress to attract interest from a potential pharmaceutical partner.

Argos released positive phase 1 clinical trial results for AGS-009 at the 2012 European League Against Rheumatism Congress (EULAR) in Berlin, Germany last week. Argos has been clear about its desire to work with a partner to develop AGS-009.

The Durham-based immunotherapy company needs the financial support of a larger partner for the lupus candidate because most of its resources are directed to its lead therapeutic candidate, an experimental kidney cancer treatment.

Argos raised $25 million in a series D round in April with proceeds intended for studying AGS-003 in phase 3 clinical trials.

Argos had planned to support its drug development efforts pipeline with an initial public stock offering that was filed last year that could have raised $65 million. But the company withdrew those plans in March and cited market conditions. Even with a public offering, the bulk of those proceeds were always intended for studying AGS-003 in renal cell carcinoma.

Lupus, an autoimmune disorder characterized by inflammation in a patient’s skin, joints and organs, affects an estimated 1.5 million Americans, according to the Lupus Foundation of America. The disease has no cure and few treatments. Last year, GlaxoSmithKline (NYSE: GSK) received approval for Benlysta, the first new lupus treatment in more than 50 years. But Argos noted in its securities filings that even Benlysta has limitations. For example, the drug does not appear to work in African-American patients.

AGS-009 was discovered through dendritic cell research from Argos. The company developed the compound following a $1 million grant by the Alliance for Lupus Research in 2005 to develop a monoclonal antibody-based lupus therapy. AGS-009 is a monoclonal antibody that has the ability to bind and neutralize interferon alpha, a protein that induces inflammation. Interferon alpha is activated and produced by dendritic cells. Patients who received AGS-009 in the phase 1 study shifted toward normal interferon alpha levels after a single dose. Patients who received a placebo showed no such change.

While the phase 1 results are positive, it might not yet be enough to land a deal with a large pharmaceutical company. In their efforts to reduce risk, pharmas have been holding off on completing partnership deals until a drug candidate has progressed further along in clinical development. Argos said in securities filings it might start additional clinical studies on AGS-009 even if the company has not found a partner. CEO Jeff Abbey said in a statement that the company is in active partnering discussions for AGS-009 and the company is preparing to advance the candidate in additional studies.

Authored by Frank Vinluan, MedCity News, and published originally on WRAL Tech Wire.

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