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CureVac

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CureVac N.V.
Company typeNaamloze vennootschap
Nasdaq: CVAC
IndustryBiotechnology
Founded2000; 24 years ago (2000)
FoundersIngmar Hoerr,[1] Steve Pascolo, Florian von der Muelbe, Günther Jung and Hans-Georg Rammensee
HeadquartersTübingen, Germany
Key people
Franz-Werner Haas (CEO)
Total equity
  • €1.40 billion (October 2017)
Number of employees
< 700[2]
Websitewww.curevac.com
Headquarters of CureVac in Tübingen

CureVac N.V. is a German biopharmaceutical company that develops therapies based on messenger RNA (mRNA). Headquartered in Tübingen, Germany, the company was founded in 2000 by Ingmar Hoerr (CEO), Steve Pascolo (CSO), Florian von der Mulbe (COO), Günther Jung, and Hans-Georg Rammensee. CureVac has approximately 375 employees since May 2018.[2]

At the beginning of the COVID-19 pandemic, CureVac was an early starter in the race to develop a German vaccine for protection against COVID-19, caused by infection with the SARS-CoV-2 virus.[3] Clinical trials for the CureVac COVID-19 Vaccine (CVnCoV) began in June 2020, and in the same month, the German Federal Government invested €300 million in CureVac, with one of the terms of the agreement being that KfW will hold a stake of approximately 23% in the company.[3][4][5] In June 2021 the company announced that CVnCoV displayed inadequate results in Phase III clinical trials with only 47% efficacy.[6] In October 2021 the company announced it would be abandon further research and development into CVnCoV and would instead focus its efforts in collaborating with GSK to develop improved mRNA vaccine technology.[7][8]

The company's focus is on developing vaccines for infectious diseases and drugs to treat cancer and rare diseases. 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,[9][10] Coalition for Epidemic Preparedness Innovations, the International AIDS Vaccine Initiative,[11] and the government of Germany.[12]

History

Research collaborations

In 2007, Curevac received the innovation prize of the state of Baden-Württemberg[13] and was also the winner of the nationwide Weconomy competition, which is jointly awarded by the Handelsblatt newspaper and the Wissensfabrik.[14]

In October 2013 CureVac launched a collaboration with Janssen Pharmaceuticals Inc., a Johnson & Johnson company, for the development of novel flu vaccines.[15] 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.[16]

In March 2014, CureVac won a €2 million prize awarded by the European Commission to stimulate new vaccine technologies.[17] Later, in July 2014, CureVac signed an exclusive license agreement with Sanofi Pasteur to develop and commercialize an mRNA-based prophylactic vaccine.[18] 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.[19]

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.[20] 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.[21] That same month, CureVac announced it would open a United States hub in Boston, Massachusetts.[22]

In accordance with its deal with Lilly, the company began construction on a production facility in 2016.[23]

In February 2019, the Coalition for Epidemic Preparedness Innovations (CEPI) awarded CureVac a $34 million grant from to develop its proprietary "RNA printer" prototype.[24] The technology is expected to allow the company to rapidly produce mRNA vaccine candidates at scale, from multiple locations globally, to bypass the logistical hurdles that often delay the production of vaccines in response to infectious disease emergencies, and also enable the production of personalized medicines.[24] The initial uses would be for their candidate vaccines for Lassa fever, yellow fever, and rabies.[24]

In July 2020, Tesla, Inc CEO Elon Musk announced via Tweet that Tesla and CureVac had reached an agreement to produce portable "RNA microfactories" based on this technology to manufacture CureVac's COVID-19 vaccine candidate.[24] CureVac had stated that the bioprinters would be able to produce “more than a hundred thousand doses” within approximately two weeks.[24] At approximately the same time, Tesla and CureVac filed a joint patent on the technology.[25] In August, Musk reviewed the project with Curevac while in Germany.[25]

Investment

By 2017, CureVac had received investments of approximately (€305 million) in the form of equity and was valued at €1.40 billion.[26] 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.[12]

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.[27]

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.[28][29] According to Welt am Sonntag, quoting an anonymous German government source, Trump had attempted to persuade CureVac to relocate to the United States, a proposal vigorously rejected by German officials.[30] 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."[31]

COVID-19 vaccine candidate

Main article: CureVac COVID-19 vaccine

CVnCoV is an mRNA vaccine that encodes a minimal piece of the coronavirus spike protein, and activates the immune system against it.[32][33] CVnCoV technology does not interact with the human genome.[32]

In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[34][35] 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.[36] In January 2021, CureVac announced a clinical development collaboration for its COVID-19 vaccine, named CVnCoV (active ingredient zorecimeran), with the multinational pharmaceutical company Bayer.[36] As of December 2020, CVnCoV was in a Phase III clinical trial of 36,500.[34][35] On 12 February 2021, CureVac announced the initiation of a rolling submission with the European Medicines Agency (EMA) for their vaccine candidate, a time-optimized process for the review of all data necessary for potential market authorization.[37] On 16 June 2021, the CureVac announced that phase III-trials of its mRNA-vaccine showed an efficacy of 47%.[38] This falls short of the European Medicines Agency's target efficacy of at least 50%.[39]

Beyond CVnCoV, CureVac has also partnered with GlaxoSmithKline (GSK) to develop a new generation of mRNA-based COVID-19 vaccines. Human testing is due in late 2021.[40][needs update]

The start of the phase 1 study with the product candidate CV2CoV, which was announced for the fourth quarter of 2021, had to be postponed to the first quarter of 2022. Since an approval-relevant study for the new vaccine can only be carried out in the fourth quarter of 2022, the goal originally set for mid-October of “obtaining official approval for the marketability of an improved Covid-19 vaccine in 2022” can be achieved in 2023 at the earliest.[41]

References

  1. ^ "CureVac Announces New Management Structure" (Press release). Curevac.
  2. ^ a b "Company Information". Curevac.
  3. ^ a b Miller, Joe; Chazan, Guy; Cookson, Clive (15 June 2020). "Berlin to buy stake in Covid-19 vaccine player CureVac". Financial Times. Retrieved 14 August 2023.
  4. ^ Sovereign (15 June 2020). "German Federal Government invests 300 Million Euros in CureVac". CureVac. Retrieved 14 August 2023.
  5. ^ "German government invests in the development of a vaccine". Website of the Federal Government | Bundesregierung. 17 June 2020. Retrieved 14 August 2023.
  6. ^ Cohen, John (18 June 2021). "What went wrong with CureVac's highly anticipated new mRNA vaccine for COVID-19?". Science.org.
  7. ^ Szymanska, Zuzanna; Burger, Ludwig (12 October 2021). "CureVac drops COVID-19 vaccine, pins hope on next-generation shots". Reuters. Retrieved 14 August 2023.
  8. ^ Solomon, Erika; Kuchler, Hannah (12 October 2021). "CureVac drops Covid vaccine to focus on new jab with GSK". Financial Times. Retrieved 14 August 2023.
  9. ^ Carroll, John (18 October 2017). "Eli Lilly is making a $1.8B leap into the mRNA field, targeting next-gen cancer vaccines". endpts.com.
  10. ^ Aripaka, Pushkala; Schuetze, Arno (19 July 2020). "GSK buys 10% of CureVac in vaccine tech deal". Reuters. Retrieved 21 July 2020.
  11. ^ "CureVac Opens up an mRNA Hub in Moderna's Cambridge Backyard". 10 September 2015.
  12. ^ a b "COVID-19 vaccine search: Germany buys stake in CureVac". Deutsche Welle. 15 June 2020. Retrieved 5 January 2021.
  13. ^ "CureVac GmbH erhält Innovationspreis des Lands Baden-Württemberg". www.bionity.com (in German). Retrieved 22 April 2022.
  14. ^ . 23 February 2016 https://web.archive.org/web/20160223142545/https://www.wissensfabrik-deutschland.de/portal/streamer?fid=544880. Archived from the original on 23 February 2016. Retrieved 22 April 2022. {{cite web}}: Missing or empty |title= (help)
  15. ^ "J&J's Janssen Companies Launch a Trio of Collaborations". 3 October 2013.
  16. ^ "CRI, Ludwig to Test Cancer Immunotherapy Combinations with CureVac". 4 November 2013.
  17. ^ "German RNA Vaccines Company Bags €2 Million E.U. Vaccine Prize". 12 March 2014.
  18. ^ "CureVac, Sanofi Paster in 150m-euro-plus vaccines deal". 2 July 2014.
  19. ^ "Boehringer pairs its lung cancer drug with a vaccine in $600M tie-up with CureVac". Fierce Biotech. 17 September 2014.
  20. ^ "Bill And Melinda Gates Foundation Makes Its Largest Ever Equity Investment In A Biotech Company". Forbes.
  21. ^ "IAVI and CureVac partner to further AIDS vaccine candidates". Archived from the original on 8 October 2015. Retrieved 3 December 2015.
  22. ^ "CureVac Opens up an mRNA Hub in Moderna's Cambridge Backyard Xconomy". Xconomy. 10 September 2015. Retrieved 9 June 2017.
  23. ^ "Curevac starts work on RNA-based drug plant with capacity for Lilly deal". in-pharmatechnologist.com. 30 October 2017.
  24. ^ a b c d e Blankenship, Kyle (2 July 2020). "Tesla teams up with CureVac to make 'RNA microfactories' for COVID-19 shot, Musk says". FiercePharma. Retrieved 15 December 2021.
  25. ^ a b Lambert, Fred (10 November 2020). "Elon Musk: Tesla's RNA vaccine printer for CureVac is going to be 'important product for the world'". ElecTrek. Retrieved 15 December 2021.
  26. ^ "The 8 Biggest Startups in Europe by Funding - Nanalyze". Nanalyze. 3 October 2017.
  27. ^ Tomi Kilgore (14 August 2020). "CureVac's stock debuts at nearly triple the IPO price". MarketWatch. Retrieved 15 August 2020.
  28. ^ "Was it something he said? Biotech CEO who met Trump this month exits without a word". FierceBiotech. 12 March 2020. Retrieved 15 March 2020.
  29. ^ "Germany and US wrestle over coronavirus vaccine: report". Deutsche Welle. Retrieved 15 March 2020.
  30. ^ 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.
  31. ^ CureVac (16 March 2020). "(Untitled)". Twitter. Retrieved 16 March 2020.
  32. ^ a b 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.
  33. ^ "Understanding mRNA COVID-19 vaccines". US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
  34. ^ a b "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
  35. ^ a b "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.
  36. ^ a b Ludwig Burger (6 January 2021). "CureVac strikes COVID-19 vaccine alliance with Bayer". Reuters. Archived from the original on 1 August 2020. Retrieved 7 January 2021.
  37. ^ "CureVac Initiates Rolling Submission With European Medicines Agency (EMA) for COVID-19 Vaccine Candidate, CVnCoV". CureVac Website. 12 February 2021.
  38. ^ "CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV". curevac.com (Press release). 16 June 2021. Retrieved 17 June 2021.
  39. ^ "COVID-19 vaccines: studies for approval". Europa.eu. 2 December 2020. Retrieved 17 June 2021.
  40. ^ Dolgin, Elie (18 June 2021). "CureVac COVID vaccine let-down spotlights mRNA design challenges". Nature. 594 (7864): 483. Bibcode:2021Natur.594..483D. doi:10.1038/d41586-021-01661-0. PMID 34145413. S2CID 235480198.
  41. ^ "Deutschland fällt weiter zurück". Kma - Klinik Management Aktuell. 10 (11): 62–63. November 2005. doi:10.1055/s-0036-1573504. ISSN 1439-3514. S2CID 257105518.
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