CureVac

CureVac is a biopharmaceutical company headquartered in Tübingen, Germany, that develops therapies based on messenger RNA (mRNA).^[1] The main research primarily focuses on cancer immunotherapies and prophylactic vaccines against infectious diseases.^[2] Founded in 2000, CureVac currently has about 240 employees.^[3]

Since inception, CureVac had received approximately $330 million (€300 million) in equity investments.^[4] CureVac has entered into various collaborations with multinational corporations and organizations, including agreements with Boehringer Ingelheim, Sanofi Pasteur, Johnson & Johnson, the Bill & Melinda Gates Foundation and the International AIDS Vaccine Initiative.^[5]

Technology

CureVac’s technology platform was developed in the late 1990s from the research conducted by Ingmar Hoerr and colleagues in the laboratories of Professor Hans-Georg Rammensee and Professor Günther Jung at University of Tübingen in Germany.^[6] CureVac's technology platform utilizes natural, chemically unmodified mRNA, which studies have shown elicits great therapeutic responses.^[7]

The basic principle of the company's proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.^[8] Since 2008, CureVac has applied its mRNA technology in more than 350 humans in seven clinical trials in eleven countries, including an ongoing Phase IIb trial in prostate cancer.^[9] CureVac’s mRNA programs include novel mRNA-based cancer immunotherapies and prophylactic vaccines against infectious diseases (RNActive®), molecular therapies designed to trigger the body's own production of therapeutic proteins (RNArt®), and RNA encoded antibodies (RNAntibody®).^[10]

CureVac’s development pipeline also includes clinical programs in non-small cell lung cancer (partnered with Boehringer Ingelheim) and rabies, as well as numerous development programs, including HIV, Rotavirus, RSV, Tuberculosis and further indications that are mostly part of strategic partnerships with pharma companies and NGOs.^[11]

In 2006, CureVac successfully established the first GMP facility worldwide for the manufacturing of mRNA for medical purposes.^[12] In 2016 CureVac will start the construction of an industrial scale production facility with a capacity of 30 million doses per year.^[13]

Research

Researchers from CureVac published data in Nature Biotechnology in 2012, which highlighted an experimental RNA vaccine approach for longer protection from flu.^[14]

In June 2015, CureVac announced that a study of its RNArt technology platform was published in the peer-reviewed journal Molecular Therapy, demonstrating for the first time ever that sequence-optimized, chemically unmodified mRNAs raised relevant protein levels in non-human primates without stimulating unwanted immune reaction, indicating that mRNA achieves meaningful biological effects in large animals with body weight close to humans.^[15] The study also suggested that sequence-optimized, unmodified mRNAs offer advantages when compared to chemically-modified mRNAs, including more efficacious protein translation.^[16]

In July 2015, CureVac announced a publication in the peer-reviewed Journal for ImmunoTherapy of Cancer highlighting a Phase I/IIa study of the company’s mRNA cancer immunotherapy CV9103 in advanced castration-resistant prostate cancer. The data showed the first Phase IIa clinical study in which an mRNA therapy has demonstrated antigen-specific immune responses in the majority of patients.^[17]

History

In October 2013 Curevac launched a collaboration with Janssen Pharmaceuticals Inc., a Johnson & Johnson company, for the development of novel flu vaccines.^[18]

In November 2013, CureVac announced the fourth in a series of partnerships with the Cancer Research Institute and Ludwig Cancer Research to enable clinical testing of novel cancer immunotherapy treatment options.^[19]

On March 10, 2014, CureVac won a €2 million prize awarded by the European Commission to stimulate new vaccine technologies that might help the developing world, because the company's research could lead to a new generation of vaccines that don't need refrigeration.^[20]

In July 2014, CureVac signed an exclusive license agreement with Sanofi Pasteur to develop and commercialize an mRNA-based prophylactic vaccine.^[21]

In September 2014 the company licensed the global rights for its Phase I candidate – CV9202 – to Boehringer Ingelheim. Boehringer plans to conduct trials using the mRNA vaccine in combination with afatinib in advanced and/or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) as well as inoperable stage III NSCLC. This could culminate in netting the company approximately $600 million.^[22]

In March 2015, CureVac’s investor, the Bill & Melinda Gates Foundation, agreed to provide separate funding for several projects to develop prophylactic vaccines based on CureVac’s proprietary mRNA platform.^[23]

In August 2015, CureVac announced the initiation of its third target product development program in collaboration with the Bill & Melinda Gates Foundation. The program will leverage CureVac’s RNActive® technology platform in the development of a prophylactic vaccine to protect against respiratory syncytial virus (RSV), adding to the development programs previously initiated by CureVac and the Gates Foundation targeting mRNA vaccines for HIV and Rotavirus.^[24]

In September 2015, CureVac entered into a collaboration with the International AIDS Vaccine Initiative (IAVI) to accelerate the development of AIDS vaccines, utilizing immunogens developed by IAVI and partners, delivered via CureVac’s mRNA technology.^[25]

In November 2015, CureVac raised about $110 million (€100 million) in a private placement to enable expansion of its mRNA development platform and clinical-stage pipeline. CureVac also announced the change of its corporate legal form to a joint stock company, Aktiengesellschaft (AG). This new financing round was led by Baillie Gifford, adding to the approximately $220 million CureVac has raised since its founding in 2000. The new investors, Baillie Gifford, Chartwave Limited, Coppel Family, Northview and Sigma Group, join existing investors dievini Hopp BioTech holding GmbH & Co. KG of Dietmar Hopp and the Bill & Melinda Gates Foundation.^[26]

References