CureVac Begins Clinical Study with mRNA Vaccine in Non-Small Cell
Lung Cancer
* First clinical study with mRNA vaccine CV9201 to treat non-small
cell lung cancer approved in Germany
* 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."
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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
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