CureVac GmbH, the mRNA vaccine company, today announced that the German authorities approved the start of the Phase IIa trial in Prostate Cancer after assessment of the first safety data of lead candidate CV9103, a RNActive®-derived mRNA vaccine. Results so far from the Phase I show CV9103 to be safe and well tolerated.
The drug candidate CV9103, a first in class molecule, will be further developed for the treatment of patients with hormone-refractory metastatic prostate cancer. The Paul-Ehrlich Institut has approved the start of the Phase IIa with CV9103 to further evaluate the safety, tolerability and biological activity of the vaccine. CureVac has now launched the Phase IIa in 21 patients with CV9103 via intradermal injection (multiple-dose). First results from this trial are expected by H2 2010. CV9103 is the most advanced candidate in CureVac’s vaccine pipeline of RNActive®-derived molecules for the active immunotherapy of cancer. The vaccine is comprised of modified mRNA molecules coding for four different antigens expressed by prostate cancer cells. “This is the first evaluation of CureVac’s RNActive® platform in humans,” said Ingmar Hoerr, Managing Director of CureVac. “We are confident that mRNA vaccines have the potential to become a novel class of broadly applicable therapeutic agents addressing large areas of immunotherapy. In combination with the attractive preclinical profile the results we have seen in the Phase I study strongly support our plans to develop CV9103 as a safe and efficacious treatment of prostate cancer.”
Marijke Barner, PhDCureVac GmbHPaul-Ehrlich-Str. 1572076 TübingenGermanyTel: +49(0)7071.92053-61E-Mail: communications(at)curevac.com