CureVac Reports Positive Preclinical Data for its COVID-19 Vaccine Candidate CVnCoV
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 .
The information presented here is not intended to be complete or to contain all of the information you have requested. Unless otherwise stated, statements contained herein relate to the date of the document and neither delivery of this document at any time nor the sale of securities should imply that the information contained herein is correct at any time after that date or that the Information will be updated or revised to reflect information that becomes available later or changes that occur after the date of this document.
This press release contains statements that constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements expressing CureVacs (hereafter the "Company") opinions, expectations, beliefs, plans, goals, beliefs or projections of the "Company" means future events or results as opposed to statements that are historical facts. Examples of this include discussing the company's strategies, funding plans, growth opportunities and market growth. In some instances, such forward-looking statements may include words such as "anticipate", "intend", "believe", "estimate", "plan", "aim", "project" or "expect", "may", "will" , "Would", "could", "potentially", “Intend” or “should”, the negative of these terms or similar expressions. Forward-looking statements are based on the current assessments and assumptions of the management as well as on information currently available to the company. However, these forward-looking statements are not a guarantee of the Company's performance and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties, and other variable circumstances, including adverse global economic conditions and continued instability and volatility in global financial markets, the ability to obtain funding, the ability to conduct current and future preclinical and clinical studies, the schedule, the cost and uncertainty of regulatory approval, reliance on third parties and collaborators, the ability to market products, the ability to manufacture products, possible changes in current and planned laws, regulations and government policies, pressures from increased competition and industry consolidation of the company, the impact of the COVID-19 pandemic on the business and operating results of the company, the ability to manage growth, the reliance on key personnel, the reliance on intellectual property protection, the ability to care for patient safety too concerns, and fluctuations in operating results due to the effects of foreign exchange rates or other factors. Such risks and uncertainties can lead to that the statements are inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are beyond the control of the company and could cause actual results to differ materially from those expected by the company.
The forward-looking statements contained in this press release speak only as of the date of this document. The company undertakes no obligation and expressly disclaims any obligation to update such statements or to publicly announce the results of revisions to such statements to reflect future events or developments, unless required by law.
For more information, please see the company's reports and documents filed with the US Securities and Exchange Commission (SEC). You can obtain these documents through EDGAR on the SEC's website at www.sec.gov .
Posted: October 2020
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