Argos Therapeutics Announces Initiation of a Phase 2 Clinical Trial of AGS-003 for the Treatment of Non-small Cell Lung Cancer in Combination with Standard-of-Care Chemotherapy

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.”

To learn more about the clinical trial visit, call 402-697-2229, or send an e-mail to

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.

Forward-Looking Statements

Any statements in this press release about Argos’ future expectations, plans and prospects, including statements about the expected and potential future closings of the private placement, Argos’ financial prospects, anticipated use of proceeds, future operations and sufficiency of funds for future operations, clinical development of Argos’ product candidates, expectations regarding future clinical trials and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," “may,” "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the conditions for the potential future closings of the private placement will be satisfied; whether Argos' cash resources will be sufficient to fund its continuing operations for the periods anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Argos’ Form 10-Q for the quarter ended September 30, 2015, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos’ views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos’ views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos’ views as of any date subsequent to the date hereof.

Investor Contact: John Menditto Argos Therapeutics, Inc. 919-908-0687 Media Contact: Adam Daley Berry & Company Public Relations 212-253-8881

Source:Argos Therapeutics Inc.