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
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.
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.
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.
Dr. Martina Schwarzkopf
Russo Partners, New York
T: + 1 (212) 845 4292
M: + 1 (347) 591 8785
T: + 1 (212) 845 4251
Verena Lauterbach, Manager Communications
CureVac GmbH, Tubingen, Germany
T: +49 (0) 7071 920 53 756