TÜBINGEN, Germany / BOSTON, MA, October 23, 2018 – CureVac AG, a fully integrated biopharmaceutical company pioneering the field of mRNA-based drugs, today announced the initiation of its Phase I dose-escalation clinical trial with the novel mRNA-based rabies vaccine, CV7202. This is the first-in-human clinical trial of CureVac’s naturally optimized mRNA technology delivered using a lipid nanoparticle (LNP), tailored to provide the vaccine with a strong, safe and persistent immune response. The study will assess the safety, reactogenicity, and the potential protective immune response of the vaccine.
CV7202 is a prophylactic mRNA-based vaccine encoding the rabies virus glycoprotein, RABV-G, formulated with next generation LNP. CureVac’s platform of mRNA-based therapeutics optimizes the properties of mRNA, including stability and immunogenicity, using enhanced sequences of naturally occurring building blocks. CureVac’s technology stimulates the immune system to mount a response against an antigen of choice, potentially providing potent prophylactic vaccines for the prevention of infectious diseases, such as rabies, as well as immunotherapies for the treatment of cancer.
“The first study participant enrolled in this rabies clinical trial is a significant milestone for CureVac, and allows the company to demonstrate its ability to trigger an immune response in vaccine naïve populations, which is different from vaccines just boosting an already existing immune response such as a flu vaccination,” said Dan Menichella, Chief Executive Officer of CureVac. “Our goal is to significantly improve today’s commercial three-to-five shot regimen rabies vaccines with a one or two shot solution that has a markedly longer duration. With this trial, we are taking an important step toward further validating the potential of our mRNA-based vaccine platform and therapeutic pipeline that will soon include additional oncology and rare diseases candidates.”
About the CV7202 Clinical Trial
The phase I, dose-escalation, open-label clinical trial will enroll at a single site in Germany. The study aims to enroll 130 healthy participants who are rabies vaccine naïve. Six escalating dose levels, given by intramuscular needle injection, will be tested. As a comparator cohort, ten study participants will receive the marketed treatment Rabipur®. The ClinicalTrials.gov Identifier for the CV7202 study is NCT03713086.
The primary objective of the study will be safety and reactogenicity, while secondary objectives will evaluate the potential protective immune response and immunogenicity in terms of geometric mean VNTs.
Rabies, a viral disease that causes inflammation in the brain, is almost always fatal following the onset of clinical symptoms. Rabies is primarily transmitted to humans through dogs, and, although the disease is preventable through vaccination, still occurs in more than 150 countries around the globe. Infection is responsible for tens of thousands of deaths every year, mostly occurring in Asia and Africa. The World Health Organization, the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO) and the Global Alliance for Rabies Control (GARC) have established a global “United Against Rabies” collaboration with the goal of achieving "zero human rabies deaths by 2030".1
1“Rabies Fact Sheet.” World Health Organization. September 2018. http://www.who.int/en/news-room/fact-sheets/detail/rabies. Last Accessed October 2018.