Argos Therapeutics (ARGS) Announces Publication of AGS-003 Phase 2 Case Report in KCJ; OS Stronger than Expected

November 3, 2016 8:57 AM EDT

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Argos Therapeutics Inc. (Nasdaq: ARGS) announced the publication of a Case Report in the Kidney Cancer Journal which details the clinical outcomes of two patients with intermediate risk metastatic renal cell carcinoma who had participated in a Phase 2 clinical trial of the company’s investigational immunotherapy AGS-003 in combination with sunitinib. These patients have obtained long-term control of metastatic disease that is ongoing seven years after initiation of treatment.

“Our report discusses truly remarkable cases from a Phase 2 study, where two intermediate risk mRCC patients have sustained an immune response to their disease for many years,” said lead author Gautam Jha, MD, medical oncologist at the University of Minnesota. “Perhaps most importantly, we have observed an increase in the number of effector memory T-cells associated with improved Overall Survival (OS) in 14 patients who received at least 5 doses of AGS-003. Considering AGS-003 is well-tolerated without significant additional side effects over single agent sunitinib, this investigational therapy remains promising for patients with advanced kidney cancer.”

In the open-label Phase 2 clinical trial, 21 patients with newly-diagnosed, intermediate and poor risk mRCC were treated with AGS-003 plus sunitinib as a first-line therapy. Results demonstrated a median Progression Free Survival (PFS) of 11.2 months and median OS of 30.2 months for all patients. Five patients in the trial survived for more than five years, and two patients have maintained durable immune responses for seven years. According to the International mRCC Database Consortium, similar unfavorable risk mRCC patients have an expected OS of only 14.7 months. In addition, follow-up analysis of these Phase 2 data, approximately two years after database lock, demonstrated a median OS of 61.9 months for the intermediate risk patients in the study compared with 20.7 months for similar patients in the International mRCC Database Consortium.

Argos designed AGS-003 to capture the mutated and variant antigens that are unique to each patient's tumor to induce a robust targeted immune response. This individualized immunotherapy is created using a small tumor sample and the patient’s own dendritic cells collected in a leukapheresis procedure. RNA is isolated from the tumor sample and used to program dendritic cells to target disease-specific antigens. Activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

“By capturing the array of known, unknown, and mutated antigens present in an individual patient’s specific cancer, AGS-003 appears to elicit a broad, individualized anti-tumor immune response,” said Lee F. Allen, MD, PhD, chief medical officer of Argos. “We remain focused on aggressively advancing our development program through late-stage clinical research, and continue to be encouraged by the long-term outcomes from the Phase 2 study.”

Argos is currently evaluating AGS-003 in combination with standard-of-care targeted therapy in the pivotal ADAPT Phase 3 clinical trial for the treatment of mRCC. Enrollment in this 462-patient study was initiated in February 2013 and completed in July 2015. The Independent Data Monitoring Committee (IDMC) for this study most recently recommended continuation of the study following a meeting in June 2016, with the next IDMC meeting planned for February 2017. In addition, AGS-003 is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of non-small cell lung cancer (NSCLC).

To read the full report in the Kidney Cancer Journal, visit http://kidney-cancer-journal.com/jha/.

About the Arcelis® Technology PlatformArcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

About Argos TherapeuticsArgos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases 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 mRCC. In addition, AGS-003 is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of NSCLC. Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients.

Forward Looking StatementsAny 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 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 June 30, 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
212-253-8881
adaley@berrypr.com

Investor contact:

John Menditto
Argos Therapeutics, Inc.
919-908-0687
jmenditto@argostherapeutics.com

Source: Argos Therapeutics Inc.



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