UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2021
Commission File Number 001-39446
CureVac N.V.
Friedrich-Miescher-Strasse 15, 72076
Tübingen, Germany
+49 7071 9883 0
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
FORM 20-F x FORM 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
YES ¨ NO x
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
On January 11, 2021, CureVac N.V. (the “Company”) issued a press release announcing the publication of preclinical data demonstrating the response of its COVID-19 vaccine candidate, CVnCoV, in non-human primates.
The information in this Form 6-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CUREVAC N.V. | |||
| By: | /s/ Franz-Werner Haas, LLD, LLM | ||
| Chief Executive Officer | |||
Date: January 11, 2021
EXHIBIT INDEX
| EXHIBIT NO. | DESCRIPTION | |
| 99.1 | CureVac N.V. Press Release dated January 11, 2021. |
Exhibit 99.1
CureVac’s COVID-19 Vaccine Candidate, CVnCoV, Demonstrated Efficient Protection of Non-Human Primates During SARS-CoV-2 Challenge Infection
| · | Data provided further evidence on immunogenicity and protective efficacy of CVnCoV |
| · | Induction of robust antibody and T cell responses at comparable dose tested in clinical trials |
| · | Full lung protection of CVnCoV-vaccinated animals during SARS-CoV-2 challenge infection |
TÜBINGEN, Germany/ BOSTON, USA – 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 strongly 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.