CureVac presents convincing data from the first ever Phase I/IIa clinical study with a mRNA based vaccine
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CureVac GmbH /
CureVac presents convincing data from the first ever Phase I/IIa clinical study
with a mRNA based vaccine
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* Strong results in safety, tolerability and biological activity
* First important validation of CureVac's RNActive® technology
Tuebingen (Germany), October 4, 2010. CureVac GmbH, the mRNA vaccine company,
announced today first data from an open-label phase I/IIa clinical trial of its
mRNA vaccine CV9103 in patients with hormone-refractory prostate cancer with
rising PSA and existing metastasis in the vast majority of patients. The trial
was designed to assess safety and toxicity of CV9103 as well as its ability to
induce antigen specific humoral and cellular immune responses in cancer
patients. The results suggest that CV9103 is safe, well tolerated and
biologically active. Over 70% of the study patients responded to at least one
antigen out of the four antigens in CV9103. The trial evaluated a five dose
regime of CV9103 delivered via intradermal injection in 44 patients.
The trial with CV9103, conducted in Germany and Italy, was the first to test a
immunotherapy based on CureVac´s RNActive® vaccination technology in humans.
"CureVac's therapeutic mRNA vaccine induces responses against multiple antigens
in 65% of immunologically responding patients when analyzing the data with
strict criteria. In addition, we see a response against all included antigens.
These data are extremely encouraging," said Dr. Kajo Kallen, CSO of CureVac.
"The results are seen as a first important validation of CureVac's innovative
proprietary RNActive® vaccination technology in humans."
The data generated from this first clinical application of CureVac´s RNActive®
vaccination technology provide the first clear evidence that CV9103 could
represent a real step forward in the application of a new approach to the
treatment of prostate cancer. This disease represents an area where there is an
enormous unmet clinical need and this early success provides an active stimulus
to expedite the development of this new technology.
Dr. Ingmar Hoerr, CEO of CureVac, said "These first results are excellent news
for CureVac. We are highly motivated to further demonstrate the value of our
RNActive® vaccination technology in oncology and infectious diseases."
CureVac´s RNActive® tumor immunotherapy approach is independent of the HLA
subtype. The vaccine comprises mRNA molecules encoding four different antigens
of which three are membrane bound. CV9103 is one candidate in CureVac's pipeline
of RNActive®-derived molecules for the active immunotherapy of cancer.
###
About CureVac
CureVac GmbH is a biopharmaceutical company specializing in the prophylactic and
therapeutic application of messenger RNA (mRNA). CureVac's lead programme is
dedicated to the development of active tumor immunotherapies, based on its
RNActive® technology. Furthermore CureVac develops prophylactic vaccines to
protect from viral infections as well as adjuvants.
Currently, there are two candidates in clinical stage: CV9103 to treat prostate
cancer, which in the U.S. and Europe is the most common cancer and the second
leading cause of cancer death in men. Additionally, CV9201, to treat non-small
cell lung cancer (NSCLC). Lung cancer affects more than 1.4 million people
worldwide and is the leading cause of cancer death.
CureVac, a spin-off from the Tübingen University, Germany, was established in
December 2000 and is headquartered in Tübingen with clinical development
facilities in Frankfurt. Since its inception, the Company has raised
approximately EUR 65 million. The principal investor of the company 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 CureVac's mRNA-derived Technologies
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.
CureVac has proved it is possible to modify mRNA making it suitable for
therapeutic purposes and maintaining its physiological properties. CureVac's
RNActive(®)-derived customized mRNA molecules are used to encode e.g. different
tumour-associated antigens which are expressed by cells residing in the upper
layers of the skin. Hence, 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 and molecular
design the Company has established proprietary technologies. Furthermore,
CureVac has built up a worldwide unique processing plant for manufacturing mRNA
according cGMP (current Good Manufacturing Practice). The combination of these
technologies enables the Company to design and manufacture mRNA for a broad
range of applications.
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(at)curevac.com
www.curevac.com
MC Services AG
Raimund Gabriel
T +49 (0) 89.210 228 30
Raimund.Gabriel(at)mc-services.eu
[HUG#1448504]
--- End of Message ---
CureVac GmbH
Paul-Ehrlich-Str. 15 Tübingen Germany
Press release (PDF):
http://hugin.info/141325/R/1448504/390760.pdf
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Source: CureVac GmbH via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 04.10.2010 - 09:00 Uhr
Sprache: Deutsch
News-ID 43862
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