A new a double-blind, randomized Phase 2b clinical trial of CV9104 (CureVac GmbH) for the treatment of patients with castration-resistant prostate cancer will enroll up to 200 patients in eight European countries.The purpose of this study is to determine whether the new RNActive-derived prostate cancer vaccine prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.

In developing the trial drug, CureVac,clinical stage biopharmaceutical company,is combining both the antigenic and adjuvant properties of messenger RNA (mRNAs) leading to novel and effective mRNA vaccines. These RNActive?vaccines are comprised of modified and formulated mRNA with three distinct features in which the mRNA vaccines are translated into the target antigens. The formulation and modifications lead to translatability ensuring strong antigen expression, increased stability and enhanced immune-stimulatory activity.

Patient population
The study of CV9104, which encodes antigens that are overexpressed in prostate cancer, includes chemotherapy-naive patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The primary endpoint of the study is overall survival. Eligible patients can enroll in the study through November 2013.The estimated study completion date is December 2016.

“This trial will validate the safety and investigate the clinical efficacy of [this] first-in-class mRNA-based cancer vaccine technology, [ ] in patients with metastatic castration refractory prostate cancer,” noted Arnulf Stenzl, M.D., medical director, Department of Urology, University of Tubingen, Germany, and the coordinating investigator of the study.

A robust immune response
Commenting on the trial, 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.”

Clinical trials
NCT01817738-Trial of RNActive?-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer

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