TÜBINGEN, Germany, 16 December 2013 – 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-naïve 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