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CureVac Receives IND Approval from the FDA to start its Phase I/IIa mRNA Vaccine Clinical Trial in Prostate Cancer

  • CureVac's RNActive® mRNA vaccine CV9103 to treat prostate cancer is approved for clinical studies in the US
  • First US clinical trial expected to begin in March 2009
  • First results expected in H1 2010

Tuebingen (Germany), January 5, 2009. CureVac GmbH today announced that it has received approval for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to begin a Phase I/IIa clinical study with CV9103, a RNActive® - derived mRNA (messenger RNA) vaccine. This mRNA vaccine will be tested in patients with hormone-refractory metastatic prostate cancer.

CV9103 is 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. 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 H1 2010.

Thomas Lander, M.D., Managing Director and Chief Medical Officer of CureVac, commented: "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 IND approval is a significant milestone in our goal of establishing a novel immunotherapy for the treatment of cancer."

"Without doubt, the North American market is strategically and commercially a very important area also for us. We are very pleased to work with Johannes Vieweg and his team from the Urology Clinic, Gainesville, University of Florida. Johannes and his group are among the most experienced teams in active immunotherapy," added Thomas Lander.

About CureVac's mRNA Technology Platforms

Messenger ribonucleic acid (mRNA) is a molecular 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 was overlooked for decades.

CureVac has successfully demonstrated that it is possible to modify mRNA for therapeutic purposes while maintaining its full physiological properties. CureVac's RNActive® - derived customized mRNA molecules are used to encode different tumour-associated antigens which are expressed by different cells in the upper layers of the skin. The immune system recognizes these antigens on presentation to dendritic cells and react by forming both antigen-specific T-cells and humoral antibodies.

Building on its unique expertise from many years of RNA research, molecular design and GMP-approved RNA production CureVac has established several proprietary technologies, namely:

  • RNActive®to deliver modified and formulated mRNA molecules with enhanced translational potency and self-adjuvanting activity
  • RNAdjuvant® as immune stimulant in different kinds of vaccines
  • PUREmessenger® for the GMP-production of full-length mRNA.

The combination of these technology platforms enables the Company to deliver large amounts of mRNA for a broad range of therapeutic applications.

About CureVac

CureVac GmbH is a biopharmaceutical company focusing on the therapeutic potential of messenger RNA (mRNA). CureVac's lead program is focusing on the development of tumour vaccines for the treatment of prostate cancer and non-small cell lung cancer.

CureVac, a spin-off from the Tuebingen University, Germany, was established in December 2000 and is headquartered in Tuebingen. Since its inception, the Company has raised approximately EUR 38 million. The main investor is dievini Hopp BioTech holding GmbH&Co. KG.

RNActive®, RNAdjuvant®, PUREmessenger® are registered trademarks of CureVac GmbH.

Contact CureVac GmbH Marijke Barner, PhD Paul-Ehrlich-Str. 15 72076 Tübingen Germany T +49 (0) 70 71.92 0 53-61 F +49 (0) 70 71.92 0 53-11 MC Services AG Hilda Juhasz T +49 (0) 89.210 228 20

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