Date: 2014-07-01
Type of information: Licensing agreement
Compound: mRNA-based vaccine (RNActive® vaccine)
Company: Curevac (Germany) In-Cell-Art (France) Sanofi Pasteur (France)
Therapeutic area: Infectious diseases
Type agreement: R&D licensing
Action mechanism: 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. RNActive® vaccines have self-adjuvanting properties and allow for a robust expression of the antigenic target protein, providing a strong danger signal leading to activation of different pattern recognition receptors (e.g. TLR7, TLR8) at the same time. In this way they stimulate the adaptive and innate immune systems optimally leading to a balanced humoral as well as T-cell-mediated immune response that includes antibody-producing B-lymphocytes, cytotoxic T-cells, memory T-cells and helper T-cells. RNActive® cancer immunotherapies have demonstrated favorable safety profiles and immunogenicity in clinical trials for prostate cancer and lung cancer, inducing a balanced humoral and a T-cell immune response. In the field of prophylactic vaccines for infectious diseases RNActive® vaccines have shown very promising preclinical data. 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.
Disease: undisclosed
Details: * On November 15, 2011, CureVac has concluded several agreements with Sanofi Pasteur, the vaccines division of Sanofi. First of all, CureVac and Sanofi Pasteur will further develop and apply CureVac’s proprietary RNActive® technology platform to the development of vaccines against several infectious diseases.An agency of the United States Department of Defense, the DARPA (Defense Advanced Research Projects Agency, has also selected CureVac, Sanofi Pasteur (including Sanofi Pasteur VaxDesign Corp.) and In-Cell-Art S.A.S., a French biotech company contributing its nanoparticle technology for a research proposal with total funding of $33.1 million (€ 24.47 million). In this 4-year project, CureVac and the other parties to the collaboration will further advance key aspects of CureVac’s RNActive® technology platform and will evaluate several vaccine candidates in a number of relevant disease models.
Parallel to the collaboration agreements, CureVac and Sanofi Pasteur have also signed an option agreement with pre-agreed license terms for several pre-defined pathogens. Sanofi Pasteur’s option rights are linked to fulfillment of certain agreed acceptance criteria relating to the DARPA project. CureVac retains the rights to its own core development programs and to all of its background technology for any other pathogens outside those within the Sanofi Pasteur option.
Financial terms: Under the terms of the license agreements, CureVac may receive an upfront payment from Sanofi Pasteur for each pathogen, research funding and payments for achieving several clinical, regulatory and commercial milestones. For each pathogen subject to Sanofi Pasteur’s option, the agreements could encompass up to €101.5 million for CureVac in upfront and milestone payments in addition to tiered royalties on sales of RNActive® vaccines if Sanofi Pasteur develops a prophylactic or a therapeutic vaccine against such pathogen and up to €150.5 million if Sanofi-Pasteur develops both a prophylactic and a therapeutic vaccine. Under the license agreements, Sanofi Pasteur will fund all research and development activities and will have exclusive marketing rights worldwide for RNActive® vaccines against the pathogens for which Sanofi Pasteur has exercised the option.
Latest news: * On July 1, 2014, CureVac announced the execution of an exclusive license agreement with Sanofi Pasteur, the vaccines division of Sanofi, 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. 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.
