CureVac of Germany has announced that the country’s regulatory authority has approved the firm’s clinical trial application to begin a Phase I study of its messenger ribonucleic acid (mRNA) vaccine in patients with hormone-refractory metastatic prostate cancer.

The vaccine, CV9103, comprises modified long chain mRNA molecules coding four different antigens expressed by prostate cancer cells. The Phase I trial will be conducted in Germany and Italy and the Tuebingen-based company said that initial results are expected by the third quarter of next year.

Thomas Lander, managing director of CureVac noted that CV9103 is the first mRNA-based vaccine entering clinical trials in prostate cancer to be administered directly into the skin. He added that “this is a significant milestone for both the CureVac team and the scientific and medical community involved with active immunotherapy of cancer”.

He added that 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".