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news.CureVac, a biopharmaceutical company, has received approval for its investigational new drug application with the FDA to begin a Phase I/IIa clinical study with CV9103, an RNActive-derived mRNA vaccine, that will be tested in patients with hormone-refractory metastatic prostate cancer.
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The Phase I/IIa trial is designed to assess the safety, tolerability and biological activity of the vaccine. CureVac expects to start the treatment of the first patient in March 2009. First results from the Phase I/IIa trial are expected by the first half of 2010.
CV9103 is said to be the most advanced candidate in CureVac’s vaccine pipeline of RNActive-derived molecules for active immunotherapy of cancer. The vaccine is comprised of modified long chain mRNA molecules coding for four different antigens expressed by prostate cancer cells.
Thomas Lander, managing director and chief medical officer of CureVac, said: Only shortly after receiving the approval of clinical development in the EU a few weeks ago, we are now looking forward to also starting the first Phase I/IIa trial in the US.
CV9103 is the first mRNA-based vaccine to enter clinical trials in prostate cancer. This investigational new drug approval is a significant milestone in our goal of establishing a novel immunotherapy for the treatment of cancer.