Navigation Links
Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
Date:4/24/2012

DURHAM, N.C., April 24, 2012 /PRNewswire/ -- Argos Therapeutics Inc. today announced that it has secured a $25 million Series D financing to support the commencement of its Phase 3 ADAPT study in patients with newly diagnosed, metastatic renal cell carcinoma (mRCC) in mid-2012. The financing was led by Forbion Capital and included other existing investors, including TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds. Argos's Arcelis™ immunotherapy, AGS-003, has also been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mRCC.  The international Phase 3 ADAPT study is expected to commence in mid-2012 under a revised Special Protocol Assessment (SPA) agreement with the FDA. This pivotal study will evaluate the addition of AGS-003 to standard therapy versus standard therapy alone.

"With this latest round of financing Argos is well positioned to execute its business strategy and move forward with the planned Phase 3 ADAPT study of its lead product candidate, AGS-003," said Jeff Abbey, president and chief executive officer of Argos. "We recently presented updated results at the 2012 ASCO Genitourinary Cancers Symposium from a Phase 2 study of AGS-003 demonstrating prolonged survival in newly diagnosed, metastatic RCC patients.  Importantly, we also demonstrated that our intended mechanism of action, the induction of memory T cells, significantly correlated with improved overall survival.  The Phase 3 ADAPT study is designed to confirm these positive results and demonstrate that AGS-003 may be an effective, safe and readily combinable therapeutic option for patients with metastatic RCC."

Charles Nicolette, Ph.D., chief scientific officer and vice president of research and development of Argos, said, "The Fast Track designation by the FDA recognizes the need for more effective treatments in metastatic RCC."

The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs for the treatment of serious or life-threatening diseases with the potential to address unmet medical needs. Fast Track designation allows for the review timeline to be truncated to six months compared to the traditional 12 months.

The Phase 3 ADAPT study is a randomized, multicenter, open-label study of AGS-003 in combination with sunitinib compared to sunitinib plus placebo. Argos plans to enroll approximately 450 mRCC patients at approximately 100 clinical sites in North America and Europe. The primary endpoint for the ADAPT study is overall survival. Additional endpoints include overall response, immune response, progression-free survival and safety.

Regarding the Phase 2 clinical study, 21 patients with newly diagnosed metastatic clear cell RCC were enrolled. Treatment consisted of six-week cycles of sunitinib, four weeks on and two weeks off, plus AGS-003, which was administered as an intradermal injection every three weeks for five doses, and then every 12 weeks until progression in combination with sunitinib. Results presented during the 2012 ASCO Genitourinary Cancers Symposium indicated that the median progression-free survival in patients with newly diagnosed, unfavorable risk mRCC was 11.2 months and estimated Kaplan-Meier median overall survival was 29.3 months in this study, based upon follow-up through January 2012. In addition, AGS-003 was well tolerated in combination with sunitinib, with no immunotherapy related serious adverse events observed.   

About the Arcelis™ Technology

Arcelis is Argos's proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies. This platform is based on optimizing a patient´s own (autologous) dendritic cells to trigger a tumor- or pathogen-specific immune response. To address the challenge of the unique genetic profile of each patient´s disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA ("mRNA") isolated from the patient´s disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is fully personalized for each patient's disease.

About Argos Therapeutics

Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on its Arcelis™ technology platform. Using biological components from each patient, Arcelis-based immunotherapies employ the patient's dendritic cells to activate an immune response specific to the patient's disease. Argos' most advanced product candidates include AGS-003 for the treatment of metastatic renal cell carcinoma, or mRCC, and AGS-004 for the treatment of HIV. 

Contact:

David Schull or Andreas Marathovouniotis
Russo Partners LLC
(212) 845-4271 or (212) 845-4235
david.schull@russopartnersllc.com or andreas.marathis@russopartnersllc.com

Jeff Abbey
Argos Therapeutics
(919) 287-6308
jabbey@argostherapeutics.com

 


'/>"/>
SOURCE Argos Therapeutics Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Results From Argos Therapeutics Arcelis™ Immunotherapy Phase 2 Study for Treatment of Renal Cell Carcinoma (RCC) Accepted for Poster Presentation at Ninth International Kidney Cancer Symposium
2. Argos Therapeutics to Present Recent Clinical Developments and Corporate Overview at 18th Annual BioPartnering Europe
3. Argos Therapeutics to Present Overview of its Arcelis™ Dendritic Cell-based Immunotherapy, Participate in Panel Discussion at Inaugural Cancer Immunotherapy Conference
4. Argos Therapeutics to Present Potential of its Arcelis™ Immunotherapy as an Innovative, Effective Treatment for HIV at the APHA 138th Annual Meeting & Exposition
5. Interleukin (IL)-12 Secretion Can Predict Potency of Argos Therapeutics Arcelis™ Dendritic Cell (DC) Immunotherapy and Can Be Used as Potency Marker in Phase 3 Clinical Trial
6. Argos Therapeutics Arcelis™ Immunotherapy for the Treatment of Renal Cell Carcinoma (RCC) in Combination With Sunitinib Demonstrates Strong Immunologic Response That Correlates to Improved Clinical Outcomes
7. Argos Therapeutics Files Registration Statement for Proposed Initial Public Offering
8. Argos Therapeutics Late Scientific Co-founder Ralph Steinman, M.D., Awarded Nobel Prize in Medicine for Discovery of Dendritic Cells as Critical Sentinels of Immune System
9. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
10. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
11. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... 2017 The global emerging cancer diagnostics market ... from 2016 to 2023 and reach a figure of ... is a chronic disease and is affecting a huge ... market. This report is focused on emerging cancer diagnostics ... is propelled due to factors such as: increasing number ...
(Date:3/28/2017)... 2017  Medeon Biodesign, Inc., a ... to announce that the Company led and successfully ... Inc., a San Jose, CA ... orthopedic extremity applications.  The orthopedic ... due to procedure volume growth, lifestyle influences and ...
(Date:3/28/2017)... -- "US Cancer Generics Market Outlook 2022" report gives ... analysis related to the emergence and integration of ... US. The report analyzes various clinical and non-clinical ... drugs in recent years. The introduction of generics ... for various stake holders involved US cancer drug ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... ... the first technology to directly address the resolution to globally reduce the harmful ... a patented compound of FDA and TTB approved ingredients that when infused into ...
(Date:3/28/2017)... ... March 28, 2017 , ... Resoundant, Inc., the developer of ... Siemens Healthineers annual customer education symposium, a world-class learning conference that offers educational ... 27 - 31, 2017 at the Atlanta Marriott Marquis in Atlanta, Georgia. , ...
(Date:3/28/2017)... ... March 29, 2017 , ... The Thyroid Secret is a ... FASCP. The program was recently launched on March 1, and Dr. Wentz discussed ... , Dr. Izabella Wentz is a licensed pharmacist and a foremost thyroid ...
(Date:3/28/2017)... Seattle, WA (PRWEB) , ... March 28, 2017 ... ... reach a 22% share of all holidays (IBT World Travel Trends Report). As ... physically challenging, include a range in temperatures, and prolonged sun exposure. In response, ...
(Date:3/28/2017)... ... March 28, 2017 , ... ... advancing the science and clinical practice of radiosurgery, announced today the publication ... multi-institutional, observational registry established to standardize data collection from patients treated with ...
Breaking Medicine News(10 mins):