Thu, 28 Jan 2021

  • Data provided further evidence on immunogenicity and protective efficacy of CVnCoV
  • Induction of robust antibody and T cell responses at lower dose than tested in Phase 3 trial
  • Full lung protection of CVnCoV-vaccinated animals during SARS-CoV-2 challenge infection

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / January 11, 2021 / CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced the publication of preclinical data demonstrating the induction of robust antibody and T cell responses of its COVID-19 vaccine candidate, CVnCoV, in non-human primates. Furthermore, rhesus macaques were shown to be protected from challenge infection with SARS-CoV-2 following vaccination with 8µg of CVnCoV. The data provided important evidence on the immunogenicity and protective efficacy of CVnCoV at low doses, supporting the ongoing international clinical Phase 2b/3 efficacy study applying a 12µg dose. The full manuscript of the preclinical data is available on the pre-print server bioRxiv.

'These data further strengthen the protective profile of our lead COVID-19 vaccine candidate, CVnCoV, and complement our recently published preclinical findings,' said Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac. 'Full protection of the lungs of vaccinated animals supports CVnCoV's potential in protecting humans from the devastating effects the virus has. We are very encouraged to see that CVnCoV exihibits its protective efficacy already at a low dose, which is even lower than the dose we advanced into late-stage human clinical testing.'

Within the study, CVnCoV was tested in rhesus macaques at 8µg per dose following a two-dose vaccination schedule at day 0 and day 28. Robust humoral and cellular immune responses include high levels of spike protein and RBD specific binding, virus neutralizing antibodies and T cells. Upon challenge infection, vaccinated animals showed a reduced viral load in the upper respiratory tract (nose and throat) and full protection of the lower respiratory tract (lungs), where the virus was not detectable.

About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The vaccine is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nano Particles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data supported CureVac's decision to advance a 12µg dose into its current pivotal Phase 2b/3 study, the HERALD study, which started in December 2020. Clinical trial material is provided by the company's substantial production capacities for mRNA vaccines at its headquarters in Tübingen, supported by the current expansion of manufacturing capacities in Europe, allowing broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.

About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.

CureVac Media Contact
Thorsten Schüller, Vice President Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1577
thorsten.schueller@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements
This press release contains statements that constitute 'forward looking statements' as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac (the 'company') regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potency efficacy of the company's vaccine candidate and the company's strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as 'anticipate,' 'intend,' 'believe,' 'estimate,' 'plan,' 'seek,' 'project,' or 'expect,' 'may,' 'will,' 'would,' 'could,' 'potential,' 'intend,' or 'should,' the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and 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 negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company's reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

SOURCE: CureVac



View source version on accesswire.com:
https://www.accesswire.com/623774/CureVacs-COVID-19-Vaccine-Candidate-CVnCoV-Demonstrated-Efficient-Protection-of-Non-Human-Primates-During-SARS-CoV-2-Challenge-Infection

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