Download CureVac`s Innovative Approach for Prophylactic Vaccination

Fact Sheet • June 2014
RNActive® – CureVac’s Innovative
Approach for Prophylactic Vaccination
RNActive® vaccines are a novel technology for the
generation and production of safe, efficacious and
cost-effective vaccines on basis of Messenger RNA
(mRNA). In comparison with other, already established
vaccines, CureVac’s RNActive® vaccines offer significant
advantages. The technology allows for the very rapid
production of innovative and efficacious prophylactic
vaccines within a few weeks and for the delivery of
them worldwide without the need for a cold chain.
Excellent Conditions for Rapid and Cost-Effective Production
Particularly during pandemics each day that a vaccine is available earlier counts.
CureVac is able to provide an RNActive® vaccine within a few weeks of the
identification of the pathogen.
CureVac has operated its own multi-product GMP facility already for several years.
It has a production capacity of up to 3.5 million doses. The facility allows the rapid
and cost-effective production of all RNActive® vaccines from one common platform.
CureVac’s vaccine production process can be adapted to the manufacture of a novel
RNActive® vaccine within a few days with minimal investments required.
Alternatively, multiple RNActive® vaccines can be produced in parallel.
Core Feature for Worldwide Distribution: Thermal Stability
The cold chain is a critical but vulnerable component of current global vaccine
distribution and storage. CureVac’s RNActive® vaccines display exceptional storability
and thermal stability. They are completely protected against high temperature as well
as low, freezing temperatures. RNActive® vaccines eliminate the necessity of cold
chain logistics thus ensuring easy distribution throughout the world.
CureVac – the RNA people®
CureVac’s ambition is to uncover novel options
for the medical use of RNA and mRNA. CureVac
was founded in the year 2000 in Tübingen,
Germany. Today, this biopharmaceutical company
possesses robust and versatile mRNA technology
platforms that are well positioned to address
global healthcare needs. ‘The RNA people’
have the ambitious goal of making the first
mRNA-based drug available to patients in need.
With its RNActive® technology, CureVac is
advancing the field of mRNA-based cancer
immunotherapies and prophylactic vaccines
against infectious diseases. Furthermore, CureVac
is using RNA as the basis of RNAdjuvant®,
innovative adjuvants for enhancing the immune
response of peptides, proteins and other vaccines.
CureVac has successfully established the first
GMP facility worldwide for the manufacture of
mRNA and has pioneered mRNA-based drugs in
clinical studies.
Leap Forward in Vaccine Technology – CureVac
Wins 2 Mio EUR Vaccine Prize from European
Commission
In March 2014, CureVac received the inaugural
European Commission Vaccine Prize. The EU
has dedicated the prize of 2 million Euros in
an effort to stimulate innovative solutions
to vaccine transportation and storage where
cold chain cannot be guaranteed. CureVac’s
RNActive® vaccine technology convinced the
panel of judges of its potential as a novel vaccine
platform with the ability to revolutionize the way
vaccines will be developed, manufactured and
distributed around the world. As a result of its
exceptional stability RNActive® vaccines could
eliminate the need for cold chain logistics.
mRNA – Promising Basis for Prophylactic Vaccines
mRNA is a very promising molecule for prophylactic vaccines. Its physiological role is to transfer genetic, protein-building
information from the cell’s nucleus to the cytoplasm where this information is translated into the corresponding protein.
CureVac embraces this natural mechanism in order to enable the patient’s body to produce its own therapy or vaccine.
RNActive® is thus a “minimal” vaccine – only the mRNA molecules encoding the relevant protein antigens are injected into the
patients. Immunization with several antigens as well as antigen engineering is feasible and can serve as the basis for
optimized and broadly protective vaccines.
RNActive® Vaccines Lead to Optimal Immune Responses
RNActive® vaccines have self-adjuvanting properties and allow for the robust and transient expression of the relevant protein
antigen. Thereby RNActive® vaccines stimulate the adaptive and innate immune systems leading to a very balanced humoral as
well as cell-mediated immune response.
CureVac GmbH • Paul-Ehrlich-Strasse 15 • 72076 Tübingen, Germany
T + 49 (0) 7071 92 0 53 - 100 • F + 49 (0) 7071 92 0 53 -101 • [email protected] • www.curevac.com
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© 2014 CureVac GmbH. All rights reserved.
Fact Sheet • June 2014
RNActive® – Giving the
body the information to
produce its own drug
RNActive® Mode of Action
Nature Biotechnology Publication: Effective Protection Against Infectious Diseases
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 including large domestic pigs. The mRNA vaccine was immunogenic
and provided long-term protection in newborn as well as in aged mice. Additional
data revealed that full protection can be achieved upon single-dose immunization.
Clinical Trial Against Rabies
CureVac is currently evaluating an RNActive® based rabies vaccine in a clinical trial
with healthy volunteers. This phase I clinical trial is designed to assess safety and
tolerability, to determine an efficacious dose and to evaluate various routes of
delivery. The rabies vaccine is based on CureVac’s proprietary RNActive® technology
and has demonstrated excellent immunogenicity and complete protection against
this inexorably lethal viral infection in several preclinical studies.
Apollo 11 2014
“Accessing CureVac’s innovative mRNA technology may allow Sanofi Pasteur to
exploit a platform that can be more broadly applicable across indications.”
Nicolas Burdin, Head of Discovery Research at Sanofi Pasteur
In May 2014, CureVac and Sanofi Pasteur signed an exclusive license agreement 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.
Collaborations in the Field of RNActive®
Prophylactic Vaccines
• S
anofi Pasteur, DARPA and
In-Cell-Art (Start 2011)
Development of prophylactic vaccines for
use against several infectious diseases
•Janssen Pharmaceuticals
(Johnson & Johnson) (Start 2013)
Development of an influenza vaccine
•Bill & Melinda Gates Foundation (Start 2014)
Joint development of vaccines against various
infectious diseases; initial project: rotavirus
CureVac’s RNActive® Vaccine Technology
Meets the Requirements for Modern
Prophylactic Vaccines
•Induction of antibodies & antigen-specific
T cells
• Induction of long-term protection
• Protection feasible after single vaccination
• Antigen design for increased efficacy
• Applicable as multivalent vaccines
•Smart production process adaptable to novel
vaccines within hours
• Good safety and tolerability
• Stable at extreme temperatures
•Flexible in administration (different routes
and techniques)
•One-for-all standardized and scalable
production process
For more information about our company and our RNA technology,
please visit our website at www.curevac.com or contact us:
•GMP-grade vaccines can be produced
within a few weeks
CureVac GmbH • Paul-Ehrlich-Strasse 15 • 72076 Tübingen, Germany
T + 49 (0) 7071 92 0 53 - 100 • F + 49 (0) 7071 92 0 53 -101 • [email protected] • www.curevac.com
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© 2014 CureVac GmbH. All rights reserved.