Argos Therapeutics Inc. (ARGS) announced disappointing top-line results from a double-blind, placebo-controlled phase IIb study on its investigational immunotherapy, AGS-004, for the treatment of patients suffering from chronic HIV-1 infection. The company’s shares plunged 32.3% following the announcement.
The primary endpoint of the study was to compare the median viral load in patients receiving AGS-004 with that of patients in the placebo arm. Results showed that AGS-004 failed to lower the median viral load in patients in the treatment group after 12 weeks of interruption in antiretroviral therapy (ATI) compared to placebo.
However, the study revealed that AGS-004 has the potential to stimulate memory T-cell responses, which may cast a direct impact on the latent viral reservoir. According to the data, 70% of the AGS-004-treated patients who completed the ATI achieved positive antiviral memory T-cell responses prior to ATI compared to none in the placebo group. Additionally, within the treatment group, patients who achieved antiviral memory T-cell responses showed significantly fewer CD4+ T-cells with integrated HIV DNA compared to the non-responders.
Argos Therapeutics believes that based on these results, AGS-004 can be used in an ongoing HIV eradication study in adults (expected to enter stage II in the next few months) and a planned pediatric study (expected to commence in 2015), where one of the key objectives is the reduction of the latent HIV reservoir. In the second stage of the eradication study, patients on standard antiretroviral therapy will be treated with Zolinza (vorinostat) in addition to AGS-004.
Nevertheless, the company admitted the need to improve their understanding regarding the method of immune evasion by the HIV virus in the absence of standard antiretroviral therapy.
Meanwhile, Argos Therapeutics’ most advanced candidate, AGS-003 (in combination with Pfizer’s (PFE) Sutent (sunitinib)), is in a pivotal phase III study under the FDA’s special protocol assessment for the treatment of clear cell metastatic renal cell carcinoma. The company expects to complete patient enrollment in this study by the end of the first quarter of 2015. Overall survival data should be out by mid-2016.
We expect investor focus to remain on pipeline updates from the company.
Argos Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Regado Biosciences, Inc. (RGDO) and Alexion Pharmaceuticals, Inc. (ALXN). Both carry a Zacks Rank #1 (Strong Buy).
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