CureVac GmbH has entered into a partnership with the Department of Urology, University of Florida, Gainesville, U.S., to jointly advance its lead candidate CV9103 into the clinical development. The alliance covers preclinical studies and a US phase I/II trial in patients with prostate cancer who no longer respond to hormone therapy.

CV9103 is the most advanced candidate in CureVac’s unique family of RNActive®-derived molecules. It is comprised of modified single stranded mRNA (messenger RNA) coding for four different antigens expressed by prostate cancer cells. Preclinical results provide evidence for its potential to stimulate a potent and specific immune response against the tumor when injected into the skin.

“The agreement with the University of Florida represents our first step to the US as the world’s leading pharmaceutical market-place with world-class academic institutions for research and development,” says Thomas Lander, M.D., Managing Director and Chief Medical Officer of CureVac. “We intend to foster the dialogue with clinical experts and regulatory authorities on both sides of the Atlantic in order to maximize the value of our compounds, medically as well as commercially. The collaboration with Dr Vieweg and his team will secure an excellent start, as he combines unique long-standing experience in the evaluation of RNA-based therapeutic vaccines with an extensive clinical network. He has an outstanding international reputation as a leader in the field of prostate cancer immunotherapy.”

“Several studies support the therapeutic potential of mRNA for the treatment of cancer,” says Johannes W. Vieweg, M.D., Professor of Urology and Chairman of the Department of Urology. “This, however, will be the first clinical trial in the US to use the direct application route by simply injecting modified mRNA into the skin. It could reduce the complexity of mRNA-based vaccination, and I am excited to be contributing to its clinical development.”

The partnership agreement was signed yesterday by Dr Lander and Dr Vieweg during a signing ceremony at the University of Florida. The partners intend to submit an IND in the US in summer 2008 and expect to enter clinic in 2009. An additional clinical trial with CV9103 in Europe is planned.

Source: CureVac GmbH - 20.06.08 (P)