RNActive®-Derived Therapeutic Vaccine

Medical Need: At present, no curative therapy is available for subjects with advanced or metastatic prostate cancer. Approximately 1 of every 3 men present with advanced or metastatic disease; therefore, current standard therapies are ineffective and new therapeutic approaches are warranted. There is ample evidence that active immunotherapy against cancer is safe and capable of stimulating potentially therapeutic immune responses in the cancer patient. Moreover, several Phase II immunotherapy trials have suggested clinical benefit by reducing the tumor mass or prolonging time to progression in subjects with advanced prostate cancer. Potential Benefits: CV9103 is an mRNA-based vaccine for the treatment of human prostate cancer that is based on CureVac's RNActive® technology. CV9103 encodes for 4 prostate specific antigens. Because these antigens are present in prostate cancer cells, they are appropriate targets for intervention. These antigens have been shown to correlate frequently with the progression of prostate cancer, and are known to be immunogenic in humans, where they induce antigen specific T-cell or B cell expansion. As an RNA-based vaccine, CV9103 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome. CV9103 will be administered in 5 doses.