Date: 2013-12-16
Type of information: Initiation of preclinical development
phase: 2b
Announcement: completion of patient recruitment
Company: CureVac (Germany)
Product: CV9104
Action
mechanism: CV9104 is composed of six RNActive®-based compounds, each encoding for an antigen that is overexpressed in prostate cancer compared to healthy tissues. These vaccines aim to combine both the antigenic and adjuvant properties of mRNAs. They 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. is being developed for the treatment of patients with prostate cancer.
Disease: castration-resistant prostate cancer.
Therapeutic area: Cancer - Oncology
Country: Czech Republic, Germany, Spain, Sweden, Switzerland, UK
Trial
details: 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. (NCT01817738)
Latest
news: * On December 16, 2013, CureVac, a German clinical stage biopharmaceutical company, has 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.
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.
* On March 27, 2013, CureVac has 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.
