Celonic and CureVac Announce Agreement to Manufacture over 100 Million Doses of CureVac’s COVID-19 Vaccine Candidate, CVnCoV
- Celonic is prepared to manufacture more than 100 million doses of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV, per year
- More than 50 million doses are expected to be produced before the end of 2021
- The mRNA-based vaccine will be manufactured at Celonic’s state-of-the-art facility in Heidelberg, Germany
TÜBINGEN, Germany/ BOSTON, USA/ BASEL, Switzerland, March 30, 2021 / B3C newswire / -- CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA) and Celonic Group, a premium biopharmaceutical Contract Development and Manufacturing Organization (CDMO) specializing in the development and production of Advanced Therapy Medicinal Products (ATMPs) and mammalian cell line-expressed bio-therapeutics, today announced their partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV.
The parties entered into a commercial supply agreement to produce CureVac’s coronavirus vaccine candidate at Celonic’s state-of-the-art commercial manufacturing facility for biologics and ATMPs, in Heidelberg, Germany. In total Celonic will be prepared to manufacture more than 100 million doses of CVnCoV. More than 50 million doses are expected to be produced before the end of 2021. Under the terms of the initial agreement, technology and knowledge transfer is already underway. The commercial supply agreement includes manufacturing of the mRNA drug substance as well as LNP formulation of the bulk drug product.
CureVac reaffirms an expected output capacity of its broad European manufacturing network of up to 300 million doses in 2021.
“Manufacturing of sufficient quantities of vaccine is critical to combating the COVID-19 pandemic,” said Dr. Florian von der Mülbe, Chief Production Officer of CureVac. “With this partnership, we are further extending our integrated European manufacturing network, reinforcing the overall production capacity for our COVID-19 vaccine candidate, CVnCoV.”
“Since the onset of the pandemic, Celonic has committed extensive breadth of complex bio-solutions development expertise and manufacturing resources to this global challenge,” added Dr. Konstantin Matentzoglu, Chief Executive Officer of Celonic. “We have invested heavily to support our partners in bringing novel COVID-19 therapeutics and vaccines to patients, at an accelerated pace. Celonic is proud to collaborate with CureVac as part of an expansive manufacturing network in this global fight against COVID-19 by contributing to the production of its mRNA-based COVID-19 vaccine candidate, CVnCoV. With a dedicated and highly motivated team in place, Celonic is well positioned to have produced the first 50 million doses before end of 2021.”
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CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first 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 the 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 signed a collaboration agreement with Bayer in January 2021 with regards to CureVac´s current CVnCoV currently in clinical Phase 2b/3. In February 2021, CureVac and the British pharmaceutical company GlaxoSmithKline (GSK) agreed to jointly develop next-generation 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.
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.
Celonic, a global contract development & manufacturing organization (CDMO) for innovative biopharmaceuticals, including cell and gene therapy products, is part of the private and independent family-owned company J.RETTENMAIER & Söhne (JRS-Group), with currently two production sites – in Basel, Switzerland (headquarters) and Heidelberg, Germany. Celonic provides comprehensive development and manufacturing services for biotherapeutics including cell line development, USP and DSP development, GMP and non-GMP manufacturing of biopharmaceutical drug substances and drug products, along with cell expression platforms and diagnostics. With a new state-of-the-art GMP manufacturing facility for gene vectors and cell therapy, Celonic is expanding its existing ATMP development and GMP manufacturing capacity in the upcoming Life Science Park Rheintal in Stein, Switzerland.
Forward-Looking Statements 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 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.
CureVac Media Contact
Thorsten Schüller, Vice President Communications
CureVac, Tübingen, Germany
+49 7071 9883-1577
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
Vikalp Mohan, COO
Celonic, Basel, Switzerland
+41 61 56 49 150
Keywords: Humans; COVID-19 Vaccines; SARS-CoV-2; RNA, Messenger; COVID-19; Pandemics; Vaccines; Pharmaceutical Preparations; Biological Products; Productivity; Commerce; Germany; Switzerland
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