TUBINGEN, Germany, Dec. 16, 2013 /PRNewswire/ -- CureVac, a German clinical stage biopharmaceutical company, today announced that it has reached the targeted number of patients for its phase IIb clinical trial of the mRNA-based immunotherapy CV9104 in patients with prostate cancer within the anticipated timeline. To date CureVac has included more than 195 chemotherapy-naive patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer in eight European countries into the study.
CureVac's new prostate cancer immunotherapy CV9104 is composed of six RNActive®-based compounds, each encoding for an antigen that is overexpressed in prostate cancer compared to healthy tissues. Overall the study is designed to generate clinical proof of concept of CV9104. Primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression free survival, cellular and humoral immune response against the 6 antigens encoded by CV9104, and assessment of quality of life.
Ingmar Hoerr, Ph.D., chief executive officer of CureVac, said, "We are proud to announce the on-time completion of patient recruitment in this clinical trial. This is an important step towards our goal of delivering a novel mRNA-based treatment option for patients with prostate cancer and other malignancies. In earlier clinical studies we have shown that RNActive® cancer immunotherapies were safe and induced balanced humoral and cellular immune responses against multiple cancer antigens. We expect CV9104 to yield significant clinical benefit for patients with advanced prostate cancer. On behalf of our company, I would like to take this opportunity to thank all the patients who participate in this study as well as our principal investigator Prof. Dr. Arnulf Stenzl and the international study centers."
Detailed information about the trial can be found at http://www.clinicaltrials.gov./ct2/show/NCT01817738?term=curevac&rank=3
CureVac is combining both the antigenic and adjuvant properties of mRNA to develop novel and effective mRNA immunotherapies and prophylactic vaccines. RNActive® therapies and vaccines are comprised of modified and formulated mRNA with three distinct features: They are translated into the target antigens, and the formulation and modifications lead to translatability ensuring (1) strong antigen expression, (2) increased stability and (3) enhanced immune-stimulatory activity.
CureVac, a clinical stage biopharmaceutical company from Tubingen, Germany, is advancing the field of mRNA-based vaccination. The company uses its technology platforms for the development of novel therapeutic mRNA vaccines (RNActive®) for cancer and prophylactic vaccines for infectious diseases. Furthermore CureVac develops adjuvants based on non-coding RNAs (RNAdjuvant®) for enhancing the immune response of other vaccines. The company has successfully completed Phase I/IIa studies with its RNActive® cancer vaccines in prostate cancer and non-small cell lung cancer (NSCLC). Results so far have shown that mRNA-based products were safe and capable of inducing balanced immune responses including humoral and cellular, Th1 and Th2 and effector and memory responses. CureVac is currently running a number of clinical trials with its RNActive® vaccines, including a large randomized Phase IIb clinical trial in prostate cancer. In addition to developing its own pipeline, CureVac is collaborating with Sanofi Pasteur, In-Cell-Art and Janssen Pharmaceuticals for the development of prophylactic vaccines in infectious diseases utilizing its RNActive® technology platform. CureVac also collaborates with Cancer Research Institute and Ludwig Cancer Research to enable clinical testing of novel cancer immunotherapy treatment options.
Dr. Martina Schwarzkopf
Russo Partners, New York
T: + 1 (212) 845 4292
M: + 1 (347) 591 8785
T: + 1 (212) 845 4251
Verena Lauterbach, Manager Communications
CureVac GmbH, Tubingen, Germany
T: +49 (0) 7071 920 53 756