CureVac

CureVac N.V. is a German biopharmaceutical company, legally domiciled in the Netherlands and headquartered in Tübingen, Germany, that develops therapies based on messenger RNA (mRNA). The company's focus is on developing vaccines for infectious diseases and drugs to treat for cancer and rare diseases. Founded in 2000 by Ingmar Hoerr (CEO), Steve Pascolo (CSO), Florian von der Mulbe (COO), Günther Jung and Hans-Georg Rammensee, CureVac had approximately 240 employees in November 2015[3] and 375 in May 2018.[2]

CureVac N.V.
TypeN.V.
NASDAQ: CVAC
IndustryBiotechnology
Founded2000
FoundersIngmar Hoerr,[1] Steve Pascolo, Florian von der Muelbe, Günther Jung and Hans-Georg Rammensee
HeadquartersTübingen, Germany
Key people
Dr. Franz-Werner Haas (CEO)
Total equity
  • €1.40 billion (October 2017)
    (US$1.65 billion)
Number of employees
> 500[2]
Websitewww.curevac.com
Headquarters of CureVac in Tübingen

CureVac has entered into various collaborations with organizations, including agreements with Boehringer Ingelheim, Sanofi Pasteur, Johnson & Johnson, Genmab, the Bill & Melinda Gates Foundation, Eli Lilly and Company, GlaxoSmithKline,[4][5] Coalition for Epidemic Preparedness Innovations, the International AIDS Vaccine Initiative,[6] and the government of Germany.[7]

In January 2021, CureVac announced a clinical development collaboration for its COVID-19 vaccine, named CVnCoV (INN name zorecimeran), with the multinational pharmaceutical company, Bayer.[8] As of December 2020, zorecimeran was in a Phase III clinical trial of 36,500 participants in Germany.[9][10]

History

Research collaborations

In October 2013 CureVac launched a collaboration with Janssen Pharmaceuticals Inc., a Johnson & Johnson company, for the development of novel flu vaccines.[11] Also in 2013, CureVac announced the fourth in a series of partnerships with the Cancer Research Institute and Ludwig Cancer Research to enable clinical testing of novel cancer immunotherapy treatment options.[12]

In March 2014, CureVac won a €2 million prize awarded by the European Commission to stimulate new vaccine technologies.[13] Later, in July 2014, CureVac signed an exclusive license agreement with Sanofi Pasteur to develop and commercialize an mRNA-based prophylactic vaccine.[14] By September 2014, the company licensed the global rights for its Phase I candidate – CV9202 – to Boehringer Ingelheim. Boehringer was to conduct trials using the mRNA vaccine in combination with afatinib in advanced and/or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) as well as inoperable stage III NSCLC.[15]

In March 2015, a CureVac investor, the Bill & Melinda Gates Foundation, agreed to provide separate funding for several projects to develop prophylactic vaccines based on CureVac's proprietary mRNA platform.[16] By September 2015, CureVac entered into a collaboration with the International AIDS Vaccine Initiative (IAVI) to accelerate the development of AIDS vaccines, utilizing immunogens developed by IAVI and partners, delivered via CureVac's mRNA technology.[17] That same month, CureVac announced it would open a United States hub in Boston, Massachusetts.[18]

In accordance with its deal with Lilly, the company began construction on a production facility in 2016.[19]

Investment

By 2017, CureVac had received approximately US$359 million (€305 million) in equity investments and was valued at US$1.65 billion (€1.40 billion).[20] In June 2020, the federal government announced that the state-owned development bank KfW would immediately invest 300 million euros in Curevac, which will mean that it will hold a 23 percent stake in CureVac.[7]

On 14 August 2020, CureVac began public trading on the NASDAQ exchange under the ticker symbol, CVAC, raising US$213 million in its initial public offering.[21]

Reports of Trump administration overtures

On 11 March 2020, it was reported that CureVac AG's CEO Daniel Menichella was no longer the company's CEO, having been replaced by company founder Ingmar Hoerr. Menichella was reported to have met U.S. President Donald Trump on 2 March.[22][23] According to Welt am Sonntag, Trump had attempted to persuade CureVac to relocate to the United States, a proposal vigorously rejected by German officials.[24] On 16 March, CureVac issued a statement on Twitter, stating "To make it clear again on coronavirus: CureVac has not received from the US government or related entities an offer before, during and since the Task Force meeting in the White House on March 2. CureVac rejects all allegations from press."[25]

COVID-19 vaccine candidate
Main article: COVID-19_vaccine § Vaccine candidates

Technology platform

Zorecimeran is an mRNA technology programmed with information about the coronavirus protein as an unknown pathogen, and activates the immune system against it.[26] As an mRNA vaccine, zorecimeran has established safety, and provides a minimal, harmless piece of the coronavirus spike protein to initiate an immune response against COVID-19 disease.[26][27] Zorecimeran technology does not interact with the human genome.[26]

Manufacturing
Main article: RNA vaccine

Manufacturing of mRNA vaccines can be performed rapidly in high volume,[28] including use of portable, automated printers ("RNA microfactories") for which CureVac has a joint development partnership with Tesla.[29]

Cold chain
See also: Cold_chain § Vaccines

mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[30][31] The CureVac technology for zorecimeran uses a non-modified, more natural mRNA less affected by hydrolysis, enabling storage at 5 °C (41 °F) and relatively simplified cold chain requirements that facilitate up to three months of storage and distribution to world regions that do not have specialized ultracold equipment.[26][28]

Preorders

CureVac has a European-based network to accelerate manufacturing of zorecimeran, if proven safe and effective, for production of up to 300 million doses in 2021 and 600 million doses in 2022.[28][32] An estimated 405 million doses will be provided to EU states.[32]

Clinical trial progress

In November 2020, CureVac reported results of a Phase I-II clinical trial that zorecimeran (CVnCoV) was well-tolerated, safe, and produced a robust immune response.[33][34] In December, CureVac began a Phase III clinical trial of zorecimeran with 36,500 participants.[9][10] Bayer will provide clinical trial support and international logistics for the Phase III trial, and may be involved in eventual manufacturing should the vaccine prove to be safe and effective.[8]

See also

References
  1. "CureVac Announces New Management Structure" (Press release). Curevac.
  2. "Company Information". Curevac.
  3. "Gates, Hopp back $110M megaround for CureVac's mRNA work".
  4. Carroll, John (18 October 2017). "Eli Lilly is making a $1.8B leap into the mRNA field, targeting next-gen cancer vaccines". endpts.com.
  5. Aripaka, Pushkala; Schuetze, Arno (19 July 2020). "GSK buys 10% of CureVac in vaccine tech deal". Reuters. Retrieved 21 July 2020.
  6. "CureVac Opens up an mRNA Hub in Moderna's Cambridge Backyard". 10 September 2015.
  7. "COVID-19 vaccine search: Germany buys stake in CureVac". Deutsche Welle. 15 June 2020. Retrieved 5 January 2021.
  8. Ludwig Burger (6 January 2021). "CureVac strikes COVID-19 vaccine alliance with Bayer". Reuters. Retrieved 7 January 2021.
  9. "Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older". EU Clinical Trials Register. 19 November 2020. Retrieved 5 January 2021. Proposed INN: "Zorecimeran"
  10. "A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults". ClinicalTrials.gov. 8 December 2020. NCT04652102. Retrieved 19 December 2020.
  11. "J&J's Janssen Companies Launch a Trio of Collaborations".
  12. "CRI, Ludwig to Test Cancer Immunotherapy Combinations with CureVac". 4 November 2013.
  13. "German RNA Vaccines Company Bags €2 Million E.U. Vaccine Prize". 12 March 2014.
  14. "CureVac, Sanofi Paster in 150m-euro-plus vaccines deal". 2 July 2014.
  15. "Boehringer pairs its lung cancer drug with a vaccine in $600M tie-up with CureVac".
  16. "Bill And Melinda Gates Foundation Makes Its Largest Ever Equity Investment In A Biotech Company".
  17. "IAVI and CureVac partner to further AIDS vaccine candidates". Archived from the original on 8 October 2015. Retrieved 3 December 2015.
  18. "CureVac Opens up an mRNA Hub in Moderna's Cambridge Backyard Xconomy". Xconomy. 10 September 2015. Retrieved 9 June 2017.
  19. "Curevac starts work on RNA-based drug plant with capacity for Lilly deal". in-pharmatechnologist.com. 30 October 2017.
  20. "The 8 Biggest Startups in Europe by Funding - Nanalyze". Nanalyze. 3 October 2017.
  21. Tomi Kilgore (14 August 2020). "CureVac's stock debuts at nearly triple the IPO price". MarketWatch. Retrieved 15 August 2020.
  22. "Was it something he said? Biotech CEO who met Trump this month exits without a word". FierceBiotech. Retrieved 15 March 2020.
  23. "Germany and US wrestle over coronavirus vaccine: report". Deutsche Welle. Retrieved 15 March 2020.
  24. Carrel, Paul; Rinke, Andreas (15 March 2020). "Germany tries to halt U.S. interest in firm working on coronavirus vaccine". Reuters. Retrieved 15 March 2020.
  25. CureVac (16 March 2020). "(Untitled)". Twitter. Retrieved 16 March 2020.
  26. Schlake, Thomas; Thess, Andreas; Fotin-Mleczek, Mariola; Kallen, Karl-Josef (2012). "Developing mRNA-vaccine technologies". RNA Biology. 9 (11): 1319–1330. doi:10.4161/rna.22269. ISSN 1547-6286. PMC 3597572. PMID 23064118.
  27. "Understanding mRNA COVID-19 vaccines". US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
  28. Allie Nawrat (3 December 2020). "Q&A with CureVac: resolving the ultra-cold chain logistics of Covid-19 mRNA vaccines". Pharmaceutical Technology. Retrieved 5 January 2021.
  29. "Tesla to make molecule printers for German COVID-19 vaccine developer CureVac". Reuters. 2 July 2020. Retrieved 19 December 2020.
  30. Kartoglu, Umit; Milstien, Julie (28 May 2014). "Tools and approaches to ensure quality of vaccines throughout the cold chain". Expert Review of Vaccines. 13 (7): 843–54. doi:10.1586/14760584.2014.923761. ISSN 1476-0584. PMC 4743593. PMID 24865112.
  31. Hanson, Celina M.; George, Anupa M.; Sawadogo, Adama; Schreiber, Benjamin (19 April 2017). "Is freezing in the vaccine cold chain an ongoing issue? A literature review". Vaccine. 35 (17): 2127–33. doi:10.1016/j.vaccine.2016.09.070. ISSN 0264-410X. PMID 28364920.
  32. Fraiser Kansteiner (17 November 2020). "CureVac, armed with COVID-19 vaccine deal, plots 'pandemic-scale' Euro manufacturing expansion". FiercePharma, Questex LLC. Retrieved 5 January 2021.
  33. "CureVac's Covid-19 vaccine induces immune response in study". Clinical Trials Arena. 3 November 2020. Retrieved 5 January 2021.
  34. "CureVac's COVID-19 vaccine triggers immune response in Phase I trial". Reuters. 2 November 2020. Retrieved 5 January 2021.

Media related to Curevac at Wikimedia Commons

This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.