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CureVac and Novartis Sign Initial Agreement on Manufacturing of COVID-19 Vaccine Candidate, CVnCoV

·7-min read

DGAP-News: CureVac / Key word(s): Agreement
04.03.2021 / 13:00
The issuer is solely responsible for the content of this announcement.


CureVac and Novartis Sign Initial Agreement on Manufacturing of COVID-19 Vaccine Candidate, CVnCoV

- Novartis plans to start manufacturing of the mRNA and bulk drug product of CureVac's COVID-19 vaccine candidate, CVnCoV, in Q2 2021

- Anticipated production of up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022 at the Novartis' manufacturing site in Kundl, Austria

- Further expansion of CureVac's European manufacturing network expected to increase capacity

TÜBINGEN, Germany/ BOSTON, USA - March 04, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Novartis AG announced today that they have signed an initial agreement for the manufacturing of CureVac's COVID-19 vaccine candidate, CVnCoV. Preparations for the start of production, technology transfers and test runs are already underway. Following final agreement, Novartis plans to manufacture the mRNA and bulk drug product of the CVnCoV vaccine candidate for up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022. Delivery from the manufacturing site in Kundl, Austria, is expected to start in summer 2021.

Dr. Florian von der Mülbe, Chief Production Officer of CureVac, says: "I am very pleased that with Novartis we have found another highly experienced partner to support the production of our vaccine candidate. Together with Novartis we expect to increase significantly our manufacturing capacity and place our production network on an even broader base."

Steffen Lang, Global Head of Novartis Technical Operations and member of Executive Committee Novartis, adds: "We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac. At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand."

CureVac started building an integrated European vaccine manufacturing network with several CDMO partners in the fall of 2020. So far, CureVac is working with Bayer, Fareva, Wacker and Rentschler, among others.

About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen first for clinical development, CVnCoV, 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 Nanoparticles (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. In December 2020 CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV. In February 2021 CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.

CureVac has entered into several strategic partnerships for the further development, production and commercialization of CVnCoV. The company entered into a collaboration agreement with Bayer in January 2021 with regards to CureVac's current vaccine candidate CVnCoV. In February 2021 CureVac and the British pharmaceutical company GlaxoSmithKline (GSK) agreed to jointly develop next-generation multi-valent mRNA vaccines against COVID-19. The development of new vaccine candidates is strengthened by a partnership with the UK Government and its Vaccines Taskforce, which CureVac also entered in February 2021. GSK will also potentially contribute to this collaboration. Clinical trial and commercial 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 600 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 potential efficacy of the company's vaccine and treatment candidates 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


04.03.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de

Language:

English

Company:

CureVac

Friedrich-Miescher-Str. 15

72076 Tübingen

Germany

EQS News ID:

1173145


 

End of News

DGAP News Service

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