Argos’ Arcelis personalized RNA-loaded dendritic cell immunotherapy technology platform has been validated in human clinical trials in kidney cancer and HIV. In the initial clinical trials in kidney cancer, the immunotherapy was well tolerated, induced a potent anti-tumor response and demonstrated encouraging clinical responses. In the initial HIV clinical trial, the immunotherapy was also well tolerated and the primary endpoint of induction of T cell response to patient-specific HIV antigens was achieved.
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Metastatic Renal Cell Carcinoma (mRCC)
Argos has completed two phase 2 clinical trials of its Arcelis™ immunotherapy, AGS-003, as both a single-agent and in combination with sunitinib in patients with newly diagnosed, metastatic RCC. Encouraging clinical and immunologic responses have been observed in these trials. In the phase 2 combination trial, the combination of AGS-003 plus sunitinib was associated with a median overall survival that was two times longer than has been reported in independent studies of sunitinib and other targeted therapies alone in intermediate and poor risk metastatic RCC patients. In these trials, AGS-003 was well tolerated (no serious adverse events attributed to AGS-003) and produced at a central manufacturing facility, with delivery to multiple clinical trial sites throughout North America.
Argos launched the ADAPT Phase 3 clinical trial for AGS-003 in January 2013. This ongoing pivotal study is expected to enroll 450 patients across approximately 140 sites in North America, Europe and Israel. To be considered for the ADAPT study patients must be 18 or older, newly diagnosed with clear cell mRCC and identified at diagnosis as unfavorable risk with 1-4 baseline risk factors, based on the Heng risk factor model. Patients must also be candidates for standard tumor removal surgery and treatment with standard targeted drug therapy, starting with sunitinib. For more information about AGS-003 and the ADAPT study, visit www.ADAPTkidneycancer.com or call 1-888-497-6953.
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Human Immunodeficiency Virus (HIV)
Argos is currently conducting a randomized, double-blind, placebo-controlled Phase 2b trial of its Arcelis immunotherapy targeted to HIV. This trial is measuring the safety and efficacy, in terms of viral load control, of the therapy. Argos recently completed treating HIV patients in a multi-center Phase 2a trial. Interim results from this Phase 2a trial, presented at the 2010 International AIDS conference, demonstrated that the candidate AGS-004 achieved a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment (ART) interruption when compared to pre-ART viral loads. The novel Argos RNA-loaded DC therapy for HIV utilizes small plasma samples from infected patients to amplify large quantities of viral RNA encoding selected antigens, resulting in a personalized treatment to the patient’s own strain of virus. For further information see the following site at http://www.clinicaltrials.gov/ct2/show/NCT01069809?term=ARgos+and+HIV&rank=3
mRCC (clear cell)
Ongoing pivotal phase 3 clinical trial; completion of enrollment expected in the second half of 2015; overall survival analysis and data expected in the 2nd half 2016.
Early stage RCC
Pilot study prior to surgery in patients with kidney cancer where the disease has not spread to the lymph nodes or other parts of the body. Immune marker expression data analysis expected in the 2nd half of 2017.
Enrollment in phase 2b clinical trial complete; data presented in the first quarter of 2015.
Phase 1/2 clinical trial to evaluate the immunological response and the virologic impact of AGS-004 initiated; data analysis expected in the 2nd half of 2016.