DURHAM, N.C., March 23, 2016 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (Nasdaq:ARGS) (“Argos”), 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, today announced the initiation of an investigator-sponsored Phase 2 clinical trial of AGS-003 in combination with standard platinum-doublet chemotherapy with or without radiation in patients with newly diagnosed Stage 3 non-small cell lung cancer (NSCLC).
The study is being conducted at the Cancer Research Network of Nebraska (CRNN) and is expected to enroll 20 patients. AGS-003 will be administered either concurrently with chemotherapy and with or without radiation or sequentially with chemotherapy and with or without radiation, according to the subject’s assigned treatment arm.
“The standard of treatment of NSCLC has been chemotherapy after surgery, but now we can offer this exciting new option of individualized immunotherapy,” said Dr. Stephen Lemon, co-principal investigator and president of Oncology Associates, Omaha, Nebraska, a CRNN collaborating practice. “We are thrilled to participate in this exciting study and are hopeful that AGS-003 will be safe and effective, and help our patients fight this terrible disease.”
AGS-003 is an individualized immunotherapy designed to induce a memory T-cell response specific to each patient's cancer, including the unique tumor mutations (or neoantigens). It is produced using a small sample of RNA from a patient's own tumor, and dendritic cells derived from a cell collection procedure from the patient.
The research team at CRNN will evaluate the impact of AGS-003 on the toxicity of standard chemotherapy as the primary safety endpoint. Researchers will also measure the activation of memory T-cells in patients who complete the Induction Phase and receive five or more doses of AGS-003 to determine the immunologic response.
“We are excited that this trial has opened for enrollment. This is the first clinical trial of AGS-003 outside of metastatic renal cell carcinoma and we can now explore the potential activity of this novel immunotherapy in other solid tumors. NSCLC is interesting because it is a tumor type reported to have a high number of mutated targets for the immune system, and therefore represents an important opportunity to integrate treatment with AGS-003 during or following standard-of-care chemotherapy,” said Lee F. Allen, M.D., Ph.D., chief medical officer at Argos. “The CRNN team is among the most prominent and experienced oncology research groups in the Midwest, and we look forward to their efforts to rapidly advance this important clinical research and expand the potential indications for the use of AGS-003.”
About Lung Cancer
American Cancer Society estimated that in 2016 approximately 224,000 Americans would be diagnosed with lung cancer resulting in nearly 160,000 deaths. It is the second most common cancer and the leading cause of cancer death for men and women; about 1 out of 4 cancer deaths result from lung cancer. Between 85 and 90% of these are non-small cell lung cancer (NSCLC) histology, which includes squamous cell, adenocarcinoma, and large cell (undifferentiated) cancers. Despite early detection screening efforts, the majority of NSCLC patients continue to present with advanced stage disease (Stage III, IV) at the time of diagnosis. The mainstay of treatment for Stage IV NSCLC is limited to systemic therapies.
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer using its Arcelis® technology platform. Argos' most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of HIV, which is currently being evaluated in an investigator-sponsored Phase 2 clinical trial aimed at HIV eradication in adult patients.
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Source:Argos Therapeutics Inc.