Argos Therapeutics
Jun 13, 2016

Independent Data Monitoring Committee Recommends Continuation of ADAPT Phase 3 Clinical Trial of AGS-003 in Metastatic Renal Cell Carcinoma Following Interim Data Review

Positive outcome triggers the second tranche of the Company's previously announced financing agreement

Argos Therapeutics to host conference call with the trial's co-principal investigator, Dr. Robert Figlin, on Thursday, June 16, 2016 at 4:30 pm EDT

DURHAM, N.C., June 13, 2016 (GLOBE NEWSWIRE) -- 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, today announced 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. The next IDMC meeting is being planned to coincide with the Genitourinary Cancers Symposium in February 2017.

"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."

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.

Conference Call and Webcast Details

Argos executive management will host a conference call with Dr. Figlin beginning at 4:30 pm EDT on Thursday, June 16, 2016 to discuss the IDMC recommendation to continue the trial, and provide his perspectives on the evolving immuno-oncology field discussed at the recent American Society of Clinical Oncology (ASCO) meeting.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 30530491. A live and archived audio webcast can be accessed through the Investors section of the Company's website at The archived webcast will remain available on the Company's website for 12 months following the call.

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.

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-initiated 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 under the March 2016 securities purchase agreement 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 the IDMC's recommendation to continue the ADAPT trial will be indicative of the results of the trial; whether AGS-003 and Argos' other 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 March 31, 2016, 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.

Media Contact:
Adam Daley
Berry & Company Public Relations
[email protected]
Investor Contact:
John Menditto
Argos Therapeutics, Inc.
[email protected]