CureVac GmbH announced that the German regulatory authority, Paul-Ehrlich-Institute, has approved the Clinical Trial Application CTA to begin a Phase I clinical study with RNActive® - derived mRNA vaccine CV9103. The mRNA vaccine will be tested in patients with hormone-refractory metastatic prostate cancer.
CV9103 is the lead candidate in CureVac’s vaccine pipeline of RNActive®-derived molecules for active immunotherapy of cancer. The vaccine comprises modified long chain mRNA molecules coding four different antigens expressed by prostate cancer cells. The Phase I trial is designed to assess the safety and tolerability of the vaccine. The multicentre study will be conducted in Germany and Italy. CureVac expects to begin treatment of the first patient by year-end and intends to report initial trial results by Q3 2009. Thomas Lander, M.D., Managing Director and Chief Medical Officer of CureVac, commented: “CV9103 is the first mRNA-based vaccine entering clinical trials in prostate cancer to be administered directly into the skin. This is a significant milestone for both the CureVac team and the scientific and medical community involved with active immunotherapy of cancer. We are very excited to be able to investigate this novel therapeutic principle for the first time in patients with metastatic prostate cancer. The preclinical data for CV9103 are very encouraging and we are now determined to demonstrate that this innovative immunotherapy is safe and well tolerated in humans before entering into Phase II trials”.