CureVac launches Phase IIa mRNA Vaccine Trial in Prostate Cancer|
* First evaluation of CureVac's RNActive® vaccine technology in
* German authorities approve CV9103 for Phase IIa trial
Tuebingen (Germany), November 2, 2009. CureVac GmbH, the mRNA vaccine
company, today announced that the German authorities approved the
start of the Phase IIa trial in Prostate Cancer after assessment of
the first safety data of lead candidate CV9103, a RNActive®-derived
mRNA vaccine. Results so far from the Phase I show CV9103 to be safe
and well tolerated.
The drug candidate CV9103, a first in class molecule, will be further
developed for the treatment of patients with hormone-refractory
metastatic prostate cancer. The Paul-Ehrlich Institut has approved
the start of the Phase IIa with CV9103 to further evaluate the
safety, tolerability and biological activity of the vaccine. CureVac
has now launched the Phase IIa in 21 patients with CV9103 via
intradermal injection (multiple-dose). First results from this trial
are expected by H2 2010.
CV9103 is the most advanced candidate in CureVac's vaccine pipeline
of RNActive®-derived molecules for the active immunotherapy of
cancer. The vaccine is comprised of modified mRNA molecules coding
for four different antigens expressed by prostate cancer cells.
"This is the first evaluation of CureVac's RNActive® platform in
humans," said Ingmar Hoerr, Managing Director of CureVac. "We are
confident that mRNA vaccines have the potential to become a novel
class of broadly applicable therapeutic agents addressing large areas
of immunotherapy. In combination with the attractive preclinical
profile the results we have seen in the Phase I study strongly
support our plans to develop CV9130 as a safe and efficacious
treatment of prostate cancer."
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 tumour
vaccines and active immunotherapies (based on its RNActive®-derived
molecules) for the treatment of prostate cancer and non-small cell
Currently, there are two candidates in clinical stage: CV9103 to
treat prostate cancer, which is in the U.S. and Europe the most
common cancer and the second leading cause of cancer death in men.
Additionally, CV9201, to treat non-small cell lung cancer (NSCLC), is
being tested in Germany and Switzerland. Lung cancer affects more
than 1.4 million people worldwide and is the leading cause of cancer
CureVac, a spin-off from the Tuebingen University, Germany, was
established in December 2000 and is headquartered in Tuebingen with
clinical development facilities in Frankfurt. Since its inception,
the Company has raised approximately EUR 38 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
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 has been overlooked for decades.
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 different tumour-associated antigens which are
expressed by 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® for the design and formulation of modified mRNA serving
a broad range of applications like therapeutic and prophylactic
* RNAdjuvant® as an immune stimulant to improve the efficacy of
prophylactic and therapeutic vaccines,
* PUREmessenger® for the cGMP-production of full-length mRNA within
a short timeframe.
The combination of these technologies enables the Company to design
and manufacture mRNA for a broad range of applications.
Marijke Barner, PhD
T +49 (0) 70 71.92 0 53-0
F +49 (0) 70 71.92 0 53-11
MC Services AG
T +49 (0) 89.210 228 20
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