"We believe that these additional findings from our Phase 2 trial support the in vivo mechanism of action of AGS-003," said Charles Nicolette, Argos' chief scientific officer and vice president of research and development, adding, "we also believe this is the first demonstration in a clinical trial that the magnitude of an adaptive immune response following immunotherapy correlates with prolonged survival."
The Phase 2 clinical trial of AGS-003 in combination with sunitinib enrolled 21 intermediate and poor risk mRCC patients who had a time from diagnosis to initiation of systemic therapeutic treatment of less than one year. Fourteen of these patients were evaluable for immune responses, and median overall survival for these 14 patients was 39.5 months.
Earlier this year, Argos initiated a pivotal Phase 3 clinical trial for AGS-003 ("ADAPT"). The randomized, multicenter, open-label ADAPT clinical trial is designed to examine the potential for AGS-003 plus standard targeted drug therapy to extend OS versus standard therapy alone in newly diagnosed mRCC patients. Argos is using BTSVQ to analyze multi-color flow cytometry data in the ADAPT trial, which will enroll a total of 450 patients in approximately 130 global sites.
About the Arcelis™ Technology Platform
Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient's disease. It is designed to overcome immunosuppression by producing a durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies.
The Arcelis process uses only a small tumor or blood sampl
|SOURCE Argos Therapeutics Inc.|
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