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New trial in Germany for a new Vaccine!


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CV9201 mRNA vaccine is the second active immunotherapeutic agent derived from CureVac's proprietary RNActive® platform technology

* First results expected in H2 2011

Tuebingen (Germany), May 26, 2009. CureVac GmbH today announced that the Paul-Ehrlich-Institute, the German regulatory authority for medicinal products, has approved the Clinical Trial Application (CTA) to begin a Phase I clinical study with RNActive® derived mRNA vaccine CV9201. The vaccine will be tested in patients with advanced non-small cell lung cancer who have been pre-treated with different therapies.

CV9201 is the second active immunotherapeutic agent in CureVac's vaccine pipeline of RNActive® derived molecules for active immunotherapy of cancer. The vaccine comprises modified mRNA components coding for five different antigens frequently expressed by non-small cell lung cancer cells. Three of these antigens (NY-ESO-1, MAGE-C1/CT7 and MAGE-C2/CT10) are in-licensed from the Ludwig Institute for Cancer Research (LICR), New York, U.S.A. The Phase I study is designed to assess the safety and tolerability of CV9201 that will be administered directly into the skin. The multicentre study will be conducted in Switzerland and Germany at five different sites. CureVac expects preliminary results to be available in the second half of 2011.

"After approval to begin studies for our lead therapy CV9103 to treat hormone-refractory metastatic prostate cancer in the EU and US; CV9201 is now the second product within our mRNA-based vaccine portfolio entering Phase I clinical studies," commented Thomas Lander, M.D., Managing Director of CureVac. "The preclinical data for CV9201 shows great promise that the vaccine will trigger a strong immune response in turn producing antigen-specific T-lymphocytes that have the ability to attack the tumour. At this stage of development we are ensuring this immunotherapy is well tolerated and safe in humans and provides a significant immune response."


About CureVac's mRNA-derived Technology Platforms 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 was overlooked for decades.

CureVac has already demonstrated it is possible to modify mRNA so that it is 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 different 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.

Building on its unique expertise from many years of RNA research, molecular design and RNA production the Company has established several proprietary technologies, namely:

* RNActive® to deliver modified and formulated mRNA molecules with enhanced translatory potency and self-activating activity, * RNAdjuvant® as an immune stimulant in different kinds of vaccines, * PUREmessenger® for the cGMP-production of full-length mRNA.

The combination of these technology platforms enables the Company to design and manufacture mRNA for a broad range of therapeutic applications.

About CureVac CureVac GmbH is a biopharmaceutical company focusing on the therapeutic application of messenger RNA (mRNA). CureVac's lead programme 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, established in December 2000, is headquartered in Tuebingen with clinical development facilities in Frankfurt. Since its inception, the Company has raised approximately EUR 38 million. The Main investor is dievini Hopp BioTech holding GmbH&Co. KG, a venture capital firm owned by the Hopp family.

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

About Ludwig Institute for Cancer Research The Ludwig Institute for Cancer Research (LICR) is an international non-profit institute dedicated to understanding and controlling cancer. With operations at 73 sites in 17 countries, the LICR network quite literally spans the globe. LICR has developed an impressive portfolio of reagents, knowledge, expertise, and intellectual property, and has also assembled the personnel, facilities, and practices necessary to patent, clinically evaluate, license, and thus translate, the most promising aspects of its own laboratory research into cancer therapies. For further information please visit www.licr.org.

Contact CureVac GmbH Marijke Barner, PhD Paul-Ehrlich-Str. 15 72076 Tübingen Germany

T 49 (0) 70 71.92 0 53-0 F 49 (0) 70 71.92 0 53-11 Marijke.Barner@curevac.com www.curevac.com

MC Services AG Hilda Juhasz T 49 (0) 89.210 228 20 Hilda.Juhasz@mc-services.eu

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

Url zum Artikel: http://www.ad-hoc-news.de/curevac-begin ... n/20246369

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