TUBINGEN, Germany, March 27, 2013 /PRNewswire/ -- CureVac GmbH, a clinical stage biopharmaceutical company that has pioneered the development of a new class of therapies and vaccines based on messenger RNA (mRNA), today announced that it has initiated a double-blind, randomized Phase 2b clinical trial of its RNActive® cancer vaccine, CV9104, for the treatment of patients with castration-resistant prostate cancer.
The Phase 2b trial will enroll up to 200 patients in eight European countries to study CV9104 in chemotherapy-naive patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The study's primary endpoint is overall survival. Eligible patients can enroll in the study through November 2013. Recruiting clinical trial sites and additional information can be found at www.clinicaltrials.gov.
"This trial will validate the safety and investigate the clinical efficacy of CureVac's first-in-class mRNA-based cancer vaccine technology, RNActive®, in patients with metastatic castration refractory prostate cancer," said Arnulf Stenzl, M.D., medical director, Department of Urology, University of Tubingen, Germany, and the coordinating investigator of the study.
Ingmar Hoerr, Ph.D., chief executive officer of CureVac, said, "We have shown that RNActive® vaccines are safe and induce balanced humoral and cellular immune responses against multiple cancer antigens in what was a first-of-its-kind study of an mRNA vaccine. Because of the robust immune response induced by our mRNA vaccine, we expect CV9104 to yield significant clinical benefit for patients with advanced prostate cancer. We believe that RNActive® vaccines have the potential to provide a safe and effective treatment option for patients with prostate cancer and other malignancies."
More details can be found at http://www.clinicaltrials.gov/ct2/show/NCT01817738?term=curevac&rank=2
CureVac's CV9104 RNActive® vaccine is being developed for the treatment of patients with prostate cancer. CV9104 encodes antigens that are overexpressed in prostate cancer.
CureVac is combining both the antigenic and adjuvant properties of mRNAs to develop novel and effective mRNA vaccines. RNActive® vaccines are comprised of modified and formulated mRNA with three distinct features: The mRNA vaccines 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 is developing an entirely new class of therapies based on a fundamental new understanding of the medical potential of mRNA. Using its RNA technology platform, CureVac is currently developing novel therapeutic mRNA vaccines (RNActive®) for cancer and prophylactic vaccines for infectious diseases and adjuvants based on non-coding RNAs (RNAdjuvant®) for enhancing the immune response of other vaccines. The company has successfully completed Phase 1/2a 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 are safe and capable of inducing balanced immune responses including humoral and cellular, Th1 and Th2 and effector and memory responses. In addition to developing its own pipeline, CureVac is collaborating with Sanofi Pasteur and In-Cell-Art on a $33.1 million project co-funded by Defense Advanced Research Projects Agency (DARPA) for the development of prophylactic vaccines in infectious diseases utilizing its RNActive® technology platform. For more information, please visit: http://www.curevac.com.
Verena Lauterbach, Manager Communications
CureVac GmbH, Tubingen, Germany
T: +49 (0) 7071 920 53 756