CureVac Signs an Exclusive License Agreement with Sanofi Pasteur to Develop and Commercialize an mRNA-based Prophylactic

 CureVac Signs an Exclusive License Agreement with Sanofi Pasteur to Develop
             and Commercialize an mRNA-based Prophylactic Vaccine

- Triggered by ongoing and very successful multi-year collaboration

PR Newswire

TUBINGEN, Germany, July 1, 2014

TUBINGEN, Germany, July 1, 2014 /PRNewswire/ --CureVac, a German
clinical-stage biopharmaceutical company, today announced the execution of an
exclusive license agreement with Sanofi Pasteur S.A., the vaccines division of
Sanofi (EURONEXT: SAN and NYSE: SNY), to develop and commercialize an
mRNA-based vaccine against an undisclosed pathogen.

In 2011, CureVac and Sanofi Pasteur signed a collaboration and license option
agreement for several pre-defined pathogens. CureVac met all pre-agreed
milestones and acceptance criteria relating to these agreements, and therefore
Sanofi Pasteur exercised its first option and extended its exclusive and
non-exclusive options on all five pathogens.

Under the commercial license agreement, Sanofi Pasteur will fund all research,
development, manufacturing and commercialization activities and will have
exclusive worldwide marketing rights for the RNActive^® vaccine. CureVac will
receive an undisclosed upfront payment from Sanofi Pasteur for the option
exercise and an additional payment for extending the option term for the other
pathogens.

In addition, CureVac is eligible for additional milestone payments up to
€150.5 million for achieving several clinical, regulatory and commercial
milestones, as well as royalty payments associated with products sales of
RNActive^® vaccines.

"Sanofi Pasteur's basic objective of finding new vaccine solutions to address
patients' needs is furthered by our collaboration with CureVac," comments
Nicolas Burdin, Head of Discovery Research at Sanofi Pasteur in France.
"Accessing CureVac's innovative mRNA technology may allow Sanofi Pasteur to
exploit a platform that can be more broadly applicable across indications to
develop vaccines, as the RNActive^® technology is expected to complement
conventional technologies."

"We are very pleased that our RNActive^® technology platform has reached all
significant milestones in this important collaboration with Sanofi Pasteur,
the largest company entirely dedicated to vaccines," says Ingmar Hoerr, CEO of
CureVac. "Our mRNA-based approach shows significant advantages for the
development of vaccines, particularly for infectious diseases, such as
thermostability and low cost of goods after up-scaling."

The exclusive license agreement for the development and commercialization of
an mRNA-based vaccine is also a result of the positive and still ongoing
four-year $33.1 million research collaboration of CureVac with Sanofi Pasteur
and In-Cell-Art, co-funded by the U.S. Defense Advanced Research Projects
Agency (DARPA), as announced in November 2011. Additional details of the
collaboration were not disclosed.

About RNActive^® Prophylactic Vaccines

RNActive^® vaccines are a novel technology for the generation and production
of safe, efficacious and cost-effective mRNA-based vaccines that are protected
against elevated temperature, as well as inadvertent freezing.

In March 2014 CureVac has won the €2 million Vaccine Prize of the European
Commission for its RNActive^® vaccine technology. The company received the
prize for progress towards a novel technology to bring life-saving vaccines to
people across the planet in safe and affordable ways. On the basis of
CureVac's technology, it is possible to rapidly produce the mRNA-based
vaccines against infectious diseases, and deliver these without requiring a
cold chain to the most remote areas of the world.

In vivo data published by CureVac and the Friedrich-Loeffler-Institute in
Nature Biotechnology (Dec 2012) showed that RNActive^® prophylactic vaccines
induced balanced, long-lived and protective immunity to influenza A virus
infections in various animal models. CureVac operates its own multi-product
GMP facility that allows the production of all mRNA vaccines from one common
platform.

CureVac's RNActive^® vaccines are based on optimized, antigen-encoding and
complexed mRNA molecules that stimulate the immune system. The technology
platform is designed to provide potent prophylactic and therapeutic vaccines
against infectious diseases and cancer.

About CureVac

CureVac, a clinical stage biopharmaceutical company from Tubingen, Germany, is
pioneering the field of RNA-based technology platforms for medical purposes
with which RNA is specifically optimized and formulated. Since 2000 the
company develops novel mRNA-based cancer immunotherapies and prophylactic
vaccines against infectious diseases – both under the brand RNActive^®.
Furthermore CureVac develops adjuvants based on non-coding RNAs (RNAdjuvant^®)
for enhancing the immune response of other vaccines.

CureVac's technology platform allows overcoming limitations such as the
instability of single-stranded RNA, including mRNA. By optimizing the
molecule, its stability is improved while translation levels are enhanced
without changing the amino acid sequence of the corresponding protein. CureVac
only uses naturally occurring nucleotides as building blocks for its
mRNA-based products. The immunogenicity of the molecule is achieved by
proprietary formulations.

The company has successfully completed Phase I/IIa clinical studies with its
RNActive^® cancer vaccines in prostate cancer and non-small cell lung cancer
(NSCLC). Results so far have shown that mRNA-based products were safe and
capable of inducing balanced immune responses including humoral and cellular,
Th1 and Th2 and effector and memory responses. CureVac is currently conducting
a number of clinical trials with its RNActive^® vaccines. A large randomized
Phase IIb clinical trial in castrate resistant prostate cancer with CV9104 has
been fully enrolled in December 2013.

In addition to developing its own pipeline, CureVac is amongst others
collaborating with Sanofi Pasteur, In-Cell-Art, DARPA and Janssen
Pharmaceuticals for the development of prophylactic vaccines in infectious
diseases utilizing its RNActive^® technology platform. CureVac also
collaborates with Cancer Research Institute and Ludwig Cancer Research to
enable clinical testing of novel cancer immunotherapy treatment options.

www.curevac.com

ACKNOWLEDGEMENT OF SUPPORT AND DISCLAIMER:

This press release relates to work that is supported by the Defense Advanced
Research Projects Agency under Contract No. HR0011-11-3-0001. Any opinions,
findings and conclusions or recommendations expressed in this press release
are those of the author(s) and do not necessarily reflect the views of the
Defense Advanced Research Projects Agency.

Media Contacts

Dr. Martina Schwarzkopf
Russo Partners, New York
T: + 1 (212) 845 4292
M: + 1 (347) 591 8785
T: + 1 (212) 845 4251
martina.schwarzkopf@russopartnersllc.com

Verena Lauterbach, Manager Communications
CureVac GmbH, Tubingen, Germany
T: +49 (0) 7071 920 53 756
verena.lauterbach@curevac.com

SOURCE CureVac

Website: http://www.curevac.com
 
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