CureVac begins CV9104 Phase 2b clinical trial in patients with castration-resistant prostate cancer

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."