CureVac and WACKER Sign Manufacturing Contract for CureVac’s COVID-19 Vaccine Candidate: CVnCoV

  • WACKER Supports Curevac in the Production of its mRNA-Based Vaccine Candidate Against COVID-19
  • Manufacturing at WACKER’s Biotech Site in Amsterdam is Scheduled to Start in the First Half of 2021

Tübingen / Munich / Amsterdam, Nov 23, 2020

CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Wacker Chemie AG announced today that they had signed a contract for the manufacturing of CureVac’s COVID-19 vaccine candidate CVnCoV.

Under the terms of the initial agreement, WACKER will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021. Preparations for the start of production, technology transfers and test runs are already underway. It is planned to produce more than 100 million doses of the CureVac vaccine per year at WACKER’s Amsterdam site. There is also further potential for expansion at the site in order to meet rising demand in the future.

WACKER’s CEO Rudolf Staudigl said: “We are proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.” As a CDMO (Contract Development and Manufacturing Organization), Wacker Biotech bundles WACKER Group’s biopharmaceutical activities. Its Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. The portfolio ranges from conventional live and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, WACKER has invested in the site to extend production to include mRNA-based vaccines. This new class of vaccines expands the broad vaccine portfolio Wacker Biotech offers to its customers.

Dr. Florian von der Mülbe, Chief Production Officer of CureVac, added: “With WACKER, we have found a committed and highly experienced partner for the production of our vaccine candidate in the Netherlands.” CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company will significantly increase the manufacturing capacity already existing within CureVac for CVnCoV up to several hundred million doses per year and will manage potential supply chain risks by working with several partners for each of the key manufacturing process steps.

About CVnCoV

CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. 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 support CureVac’s decision to advance a 12µg dose in its upcoming pivotal Phase 2b/3 study, which CureVac plans to initiate before the end of 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 to allow for 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.

About Wacker Biotech

Wacker Biotech GmbH and Wacker Biotech B.V. are full-service contract manufacturers of therapeutic proteins, LMPs and vaccines based on microbial systems. The company’s portfolio extends from strain/process development, through analytical testing, to production for clinical and commercial applications. Wacker Biotech maintains three GMP-compliant (Good Manufacturing Practice), FDA- and EMA-certified production plants at its German sites in Jena and Halle as well as in Amsterdam in the Netherlands. Wacker Biotech GmbH and Wacker Biotech B.V. are wholly owned subsidiaries of the Munich-based company Wacker Chemie AG (WCH888). Further information can be found at www.wacker.com/biologics

 

Forward-Looking Statements

Wacker Chemie AG

This press release contains forward-looking statements based on assumptions and estimates of WACKER’s Executive Board. Although we assume the expectations in these forward-looking statements are realistic, we cannot guarantee they will prove to be correct. The assumptions may harbor risks and uncertainties that may cause the actual figures to differ considerably from the forward-looking statements. Factors that may cause such discrepancies include, among other things, changes in the economic and business environment, variations in exchange and interest rates, the introduction of competing products, lack of acceptance for new products or services, and changes in corporate strategy. WACKER does not plan to update its forward-looking statements, nor does it assume the obligation to do so.

 

CureVac

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 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 CureVac’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.

Contact

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Media Contact

Wacker Chemie AG
Media Relations & Information
Manuela Dollinger

Tel. +49 89 6279-1629
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CureVac
Vice President Communications
Thorsten Schüller

Tel.: +49 7071 9883 1577

Thorsten.schueller@curevac.com

Investor Relations

Wacker Chemie AG
Head of Investor Relations
Joerg Hoffmann, CFA

Tel. +49 89 6279 1633
M.: +49 151 147 55 343

Nachricht senden

CureVac
Vice President Investor Relations
Dr. Sarah Fakih

Tel.: +49 7071 9883 1298
M.: +49 160 90 496949

sarah.fakih@curevac.com