The last time we wrote about CureVac was back in April when the Tübingen, Germany-based biopharmaceutical startup company was thrust into the spotlight for following the announcement it was developing mRNA vaccine against coronavirus. Then in June, CureVac received regulatory clearance to start a phase 1 trial of its COVID-19 vaccine. The 168-subject trial study comes days after the German government invested $337 million (€300 million) in CureVac to support its efforts to develop and manufacture a vaccine against the coronavirus.
The trial was scheduled to be conducted in Germany and Belgium. First subjects will be vaccinated at the Institute for Tropical Medicine in Tübingen and the Ghent University Hospital (Belgium), the Tropical Institute of the University Hospital Munich, LMU (Germany), and the Hannover Medical School (Germany).
Now almost a month after the June 17 announcement, CureVac said some 4,000 volunteers have registered to participate in the coronavirus vaccination study at the University Hospital in the south-western German city of Tuebingen. Researchers said they were surprised at the number of people who have offered to take part, as they usually struggle to find enough guinea pigs.
“It’s a real luxury situation, unlike usual clinical trials,” study director Peter Kremsner told German Press Agency (DPA) on Friday. “Normally we have trouble coming up with enough test subjects.”
Founded in 200 by Florian von der Mulbe and Ingmar Hoerr, CureVac is a clinical stage biotechnology company in the field of messenger RNA (mRNA) technology with 20 years of expertise in developing and optimizing this versatile molecule for medical purposes. The principle of CureVac’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. The company applies its technologies for the development of cancer therapies, antibody therapies, the treatment of rare diseases, and prophylactic vaccines.
CureVac´s mRNA vaccine candidate utilizes nucleotides without chemical modifications in the mRNA and is designed to provide a strong and balanced activation of the immune system. The mRNA encodes the full-length spike protein of SARS-CoV-2 and is formulated with lipid nanoparticles (LNP).
The vaccine project began in early 2020 and initially focused on characterization of several potential candidates that then led to the selection of the final candidate, termed CVnCoV. This thorough selection process was based on humoral and cellular immunogenicity data, a balanced immune-response as well as speed and capability for large scale manufacturing.
The Phase 1 dose escalation clinical trial will include 168 healthy subjects between the ages of 18 to 60 and will target a dose range of 2 µg to 8 µg. Aim is to determine the optimal dose as well as to evaluate the safety and immune profile of the vaccine in humans.
“We are encouraged that we received green light from the regulatory authorities to start the clinical development of our COVID-19 candidate. During the last few months our team has put a lot of efforts into the preclinical validation of several vaccine candidates to select an optimal construct. We are confident that our early optimization work will provide a safe and effective low dose vaccine. In parallel, we are already producing large quantities of this trial medication under GMP conditions,” says acting CEO of CureVac, Dr. Franz-Werner Haas.
