Phase I/IIa Trial
CV9104’s predecessor drug, the RNActive® vaccine CV9103, was initially investigated in a phase I/IIa trial in 44 patients with castration refractory prostate cancer. Results from this first clinical trial of CV9103 suggested that the vaccine is well tolerated with transient, mild to moderate injection site reactions and flu-like symptoms as the predominant related adverse events. Immune responses against all four antigens could be induced indicating the versatility of the platform. The follow-up vaccine CV9104 including two additional antigens is currently being tested in a randomized phase IIb trial to assess the clinical benefit induced by this new vaccination approach.
The press release on the publication of the study data can be found here.
The scientific publication of the study data can be found here.
Phase IIb Trial
This study enrolled about 200 patients with asymptomatic or minimally symptomatic metastatic prostate cancer which is castrate resistant. Patients were randomized to receive either CV9104 or placebo in a double-blinded fashion. The lead-in part of the trial had the primary objective to assess the safety of CV9104. The primary objective of the phase II part is to compare overall survival in patients treated with CV9104 compared to patients treated with placebo. Further objectives include investigation of progression-free survival, quality of life and safety. The study is ongoing.
For further information on this study please visit clinicaltrials.gov.
The press release announcing the start of this phase IIb study in March 2013 can be found here.
First topline results of the study can be found in this press release.
Further results are presently being analyzed, including latest preclinical results on the product candidate in combination with checkpoint inhibitors.