Argos Therapeutics, a biopharmaceutical company of Durham, N.C., has secured a $25 million Series D financing to support the commencement of its phase III ADAPT study in patients with newly diagnosed, metastatic renal cell carcinoma (mRCC) in mid-2012.

In addition, Argos's Arcelis immunotherapy, AGS-003—the compound being tested in the ADAPT study—has been granted Fast Track designation by the FDA for the treatment of patients with mRCC. The international phase III ADAPT study is expected to commence in mid-2012 under a revised Special Protocol Assessment (SPA) agreement with the FDA. This pivotal study will evaluate the addition of AGS-003 to standard therapy versus

Jeff Abbey, president and CEO of Argos, said that a phase II study of AGS-003 demonstrated “prolonged survival in newly diagnosed, metastatic RCC patients. Importantly, we also demonstrated that our intended mechanism of action, the induction of memory T cells, significantly correlated with improved overall survival. The phase III ADAPT study is designed to confirm these positive results and demonstrate that AGS-003 may be an effective, safe and readily combinable therapeutic option for patients with metastatic RCC."

The planned phase III ADAPT study is a randomized, multicenter, open-label study of AGS-003 in combination with sunitinib compared to sunitinib plus placebo. Argos plans to enroll approximately 450 mRCC patients at approximately 100 clinical sites in North America and Europe. The primary endpoint for the ADAPT study is overall survival. Additional endpoints include overall response, immune response, progression-free survival and safety.

The financing was led by Forbion Capital and included other existing investors, such as TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group and Aurora Funds.