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CureVac launches Phase IIa mRNA vaccine trial in prostate cancer

This will be the first evaluation of CureVac's RNActive® vaccine technology in humans.

CureVac GmbH, the mRNA vaccine company, recently announced that the German authorities have approved the start of a Phase IIa trial in prostate cancer after assessment of the first safety data of lead candidate CV9103, an RNActive-derived mRNA vaccine. Results so far from the Phase I trial show CV9103 to be well tolerated.

CV9103 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 trial with CV9103 to further evaluate the safety, tolerability and biological activity of the vaccine. CureVac has now launched the Phase IIa trial in 21 patients with CV9103 via intradermal injection (multiple dose). First results from this trial are expected by the second half of 2010.

CV9103 is the most advanced candidate in CureVac's pipeline of RNActive-derived molecules for the active immunotherapy of cancer. The vaccine comprises 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 CV9130 as a safe and efficacious treatment of prostate cancer.’

In the USA and Europe, prostate cancer is the most common cancer and the second leading cause of cancer death in men.

Messenger ribonucleic acid (mRNA) is a genetic template for protein synthesis. It delivers the information encoded by genes from DNA to ribosomes, where the information is translated into individual proteins. Natural RNA is an unstable biomolecule that is rapidly digested in the human body. As a result, its potential role as a therapeutic has been overlooked for decades. CureVac has proved it is possible to modify mRNA to make it suitable for therapeutic purposes while maintaining its physiological properties. CureVac's RNActive-derived customized mRNA molecules are used to encode different tumour-associated antigens, which are expressed by cells residing in the upper layers of the skin. Hence, the immune system will recognize these antigens on presentation to dendritic cells and react by forming both antigen-specific T-cells and humoral antibodies.

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