TÜBINGEN, Germany / BOSTON, USA – October 23, 2020 — CureVac NV (Nasdaq: CVAC), a biopharmaceutical company developing a new class of drugs based on messenger ribonucleic acid (mRNA) in clinical trials, today announced data from preclinical studies of its SARS-CoV-2 vaccine candidate CVnCoV in mice and hamsters . The vaccine candidate triggers a balanced humoral and cellular immune response, which is characterized by high antibody titers and very good T-cell activation. In addition to the positive immune response, the vaccine candidate was able to elicit favorable Th1 cytokine levels. Furthermore, in a challenge study, CVnCoV offered hamsters effective protection against the live SARS-CoV-2 virus without any evidence of an aggravation of the disease induced by the vaccine.bioRxiv available and has been submitted for possible publication in a peer-reviewed journal. The vaccine candidate is currently being investigated in Phase 1 and Phase 2a clinical trials. Phase 1 interim dates are expected to be announced shortly.
CVnCoV showed a dose-dependent activation of the humoral immune system in mice at doses of 0.25, 1 and 4 µg. The induction of strong IgG1- and IgG2a-binding antibody titers were observed in all doses which were converted into neutralizing antibodies with high efficiency. Neutralizing antibodies could still be detected even at the lowest dose and began to develop 3 weeks after the first vaccination. The titers rose sharply after the second vaccination.
The influence of different dosage regimens based on two vaccinations, a prime and a boost vaccination, was investigated for 2 µg with 1, 2, 3 or 4 weeks between the first and second vaccination. The data showed the formation of binding IgG1 and IgG2a antibodies 7 days after the first vaccination. The titers increased after the second vaccination and showed better immune responses after longer injection intervals. Binding antibodies were efficiently converted into neutralizing antibodies, which began to develop 4 weeks after the first vaccination and increased significantly after the second vaccination.
The efficient formation of neutralizing antibodies corresponded to a favorable IgG2a / IgG1 ratio, which indicates a balanced Th1 / Th2 profile. There was no evidence of a Th2-heavy immune response, suggesting a low likelihood of vaccine-induced disease exacerbation.
“The preclinical data released today show that our COVID-19 vaccine candidate has the potential to induce an effective and balanced immune response that mimics natural immune defenses and has full lung protection in a relevant challenge animal model,” said Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac. “The study greatly contributes to our understanding of CVnCoV, which is currently being investigated in phase 1 and 2a clinical trials.”
The mice vaccinated with CVnCoV showed a positive induction of multifunctional IFNg + / TFN + CD4 + and CD8 + T cells. Both were detected in convalescent COVID-19 patients, with CD4 + T cells still being essential for the formation of B memory cells. The mean values of CD4 + and CD8 + T cells were 0.34 percent and 10.5 percent after vaccination on days 0 and 28 and also benefited from longer injection intervals.
The potential protective effect of a CVnCoV vaccination has been demonstrated in hamsters, which are an established animal model for investigating human-relevant immunogenicity and pathogenesis. The administration of a vaccine dose of 10 µg to hamsters showed a very good reduction in the viral load in the upper respiratory tract and complete protection of the lungs. The lungs of the vaccinated animals continued to show no signs of increased disease as a result of the challenge virus infection.
CureVac began developing its mRNA-based vaccine candidate COVID-19 in January 2020. The active ingredient is based on optimized, chemically unmodified mRNA, which codes for the prefusion-stabilized full spike protein of the SARS-CoV-2 virus. The formulation of CVnCoV is based on the leading lipid nanoparticle technology (LNP) in-licensed from Acuitas, the company’s partner. In June 2020, the company started a clinical phase 1 study with CVnCoV in clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). At the end of September 2020, the vaccine candidate started a phase 2a clinical trial in Peru and Panama, in which clinical investigations were extended to older adults and regions with a high incidence of COVID-19 infections. The company plans to initiate a phase 2b / 3 clinical trial that is relevant for approval by the end of 2020. The material for the clinical studies is provided by the company’s considerable production capacity for mRNA vaccines at its headquarters in Tübingen. CureVac is currently expanding these production capacities in order to prepare the large-scale production of CVnCoV for possible commercial readiness for delivery. The material for the clinical studies is provided by the company’s considerable production capacity for mRNA vaccines at its headquarters in Tübingen. CureVac is currently expanding these production capacities in order to prepare the large-scale production of CVnCoV for possible commercial readiness for delivery. The material for the clinical studies is provided by the company’s considerable production capacity for mRNA vaccines at its headquarters in Tübingen. CureVac is currently expanding these production capacities in order to prepare the large-scale production of CVnCoV for possible commercial readiness for delivery.
CureVac is a global biopharmaceutical company in the field of mRNA technology (messenger RNA) with more than 20 years of experience in the development and optimization of this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is based on the use of chemically unmodified mRNA as a data carrier to guide the human body to produce the correspondingly encoded proteins with which a variety of diseases can be combated. Building on its proprietary technology, the company has built an extensive clinical pipeline in prophylactic vaccines, cancer therapies, antibody therapies, and rare disease treatment. CureVac has been listed on the New York Nasdaq since August 2020. The company is headquartered in Tübingen, Germany, and has around 500 employees at its locations in Tübingen, Frankfurt and Boston, USA. For more information, seewww.curevac.com .
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Posted: October 2020
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