On June 13, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported that the independent data monitoring committee (IDMC) for the Company’s pivotal Phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) has recommended the continuation of the trial based on results of the IDMC’s scheduled interim data review (Press release, Argos Therapeutics, JUN 13, 2016, View Source [SID:1234513245]). The next IDMC meeting is being planned to coincide with the Genitourinary Cancers Symposium in February 2017. Schedule your 30 min Free 1stOncology Demo! "As the largest global Phase 3 trial ever performed in newly diagnosed, intermediate and poor risk mRCC patients, the ADAPT trial continues to progress," said Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology, professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and the co-principal investigator for the ADAPT trial. "With all the excitement regarding the clinical benefit of the emerging immuno-oncology therapies, a positive outcome of the ADAPT trial, because of AGS-003’s novel mechanism of action, could be a game changer in the treatment of mRCC."
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AGS-003 is an individualized immunotherapy that captures both mutated and variant antigens that are unique to each patient’s tumor, and, therefore, specifically designed to induce an immune response targeting that patient’s particular tumor antigens. In an open-label Phase 2 trial, treatment with AGS-003 plus sunitinib resulted in median overall survival of more than 30 months in newly diagnosed, intermediate and poor risk mRCC patients. We have enrolled a total of 462 mRCC patients in our ongoing pivotal, randomized Phase 3 ADAPT trial evaluating AGS-003 in combination with standard targeted therapy, which has a primary endpoint of overall survival. AGS-003 is Argos’ most advanced Arcelis-based product candidate.
"The IDMC’s recommendation to continue with the ADAPT trial aligns with our expectations based on the patient population enrolled and the clinical benefit observed in the Phase 2 trial," said Lee F. Allen, MD, PhD, chief medical officer of Argos. "Based upon our internal projections, we believe that at this point we have reached more than half of the targeted number of events for our survival endpoint, and we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur in the first half of 2017. The focus of our clinical development group is now on the careful oversight of the ADAPT trial execution to ensure study data quality, and we have initiated cross functional activities to begin building the AGS-003 Biologics License Application (BLA)."
The positive outcome from the IDMC’s review of the ADAPT trial data triggers the second tranche of the financing under the Company’s previously announced March 2016 securities purchase agreement. Upon the closing of the second tranche, which is expected to occur within 30 days, the Company will receive a total of $29,824,520 from the sale of a total of 5,478,672 shares of common stock and warrants to purchase a total of 4,109,005 shares of common stock.
About the Arcelis Technology Platform
Arcelis is a precision 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 is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.