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Moderna

42°21′48″N 71°05′28″W / 42.3633°N 71.091°W / 42.3633; -71.091

Moderna, Inc.
FormerlyModeRNA Therapeutics
(2010–2018)
Company typePublic
ISINUS60770K1079
IndustryBiotechnology
FoundedSeptember 2010; 14 years ago (2010-09)
Founders
Headquarters200 Technology Square
Cambridge, Massachusetts, U.S.
Key people
Products
RevenueDecrease US$6.848 billion (2023)
Decrease US$−4.24 billion (2023)
Decrease US$−4.71 billion (2023)
Total assetsDecrease US$18.43 billion (2023)
Total equityDecrease US$13.85 billion (2023)
Owners
Number of employees
5,600 (2023)
Websitemodernatx.com
Footnotes / references
[1][2][3]

Moderna, Inc. (/məˈdɜːrnə/ mə-DUR-nə)[4] is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts, that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to carry instructions for proteins to produce an immune response.[5][1] The company's name is derived from the terms "modified", "RNA", and "modern".[6][7][8]

The company's commercial products are the Moderna COVID-19 vaccine, marketed as Spikevax and a RSV vaccine, marketed as Mresvia. The company has 44 treatment and vaccine candidates, of which 37 have entered clinical trials. Candidates include possible vaccines for influenza, HIV, Epstein–Barr virus, the Nipah virus, chikungunya, human metapneumovirus, varicella zoster virus, as well as a cytomegalovirus vaccine, a Zika virus vaccine funded by the Biomedical Advanced Research and Development Authority, and three cancer vaccines. The company's pipeline also includes a cell therapy-based treatment: a relaxin fusion protein being developed to treat acute decompensated heart failure. It also includes candidates that use OX40 ligand, interleukin 23, IL36G, and interleukin 12 for cancer immunotherapy, specifically treatment of breast cancer, urothelial carcinoma, lymphoma, and melanoma. Also being developed by Moderna is a regenerative medicine treatment that encodes vascular endothelial growth factor A to stimulate blood vessel growth for patients with myocardial ischemia.[1][failed verification]

History

Moderna was founded in 2010 by Derrick Rossi, Timothy A. Springer, Kenneth R. Chien, Robert S. Langer, and Noubar Afeyan.[9] Stéphane Bancel, the current CEO, was appointed as CEO in 2011.[6][10] Between 2011 and 2017, Moderna raised $2 billion in venture capital funding.[7][8]

In November 2024, Moderna Inc. announced that Stéphane Bancel, currently serving as Chief Executive Officer, will step down from his role as Chief Commercial Officer while continuing as CEO. Moderna's President, Stephen Hoge, will take over responsibilities for the company's sales, medical, and research affairs.[11]

Product development

In 2013, the company formed a partnership with AstraZeneca to develop treatments for cardiovascular, metabolic, and renal diseases, as well as cancer. Moderna was also awarded a $25,000,000 grant by DARPA through a program Autonomous Diagnostics to Enable Prevention and Therapeutics: Prophylactic Options to Environmental and Contagious Threats (ADEPT-PROTECT). Its stated goal was to develop an mRNA vaccine with the capability to suppress a global pandemic within 60 days. In January 2014, the company entered an agreement with Alexion Pharmaceuticals to develop treatments against ten diseases.[12] On January 14, 2014, Moderna announced the creation of its first venture, Onkaido Therapeutics, to focus "exclusively on developing mRNA-based oncology treatments."[13][14] It launched its second venture, Valera, in January 2015, with a focus on "viral, bacterial and parasitic infectious diseases."[15][16] Employees of Valera and Moderna developed an mRNA vaccine candidate against Zika virus infection.[17] Another venture, Elpidera, was announced in May 2015 to continue work on RNA therapies advancing Moderna's work with Alexion.[18][19]

In 2015, the company formed a partnership with Merck & Co. to develop treatments for cancer, and in 2016 the company formed a partnership with Vertex Pharmaceuticals to develop treatments for cystic fibrosis.[10][20][21][22] In January 2016, the Bill & Melinda Gates Foundation committed to provide at least $20 million in grant funding to the company.[1] In 2017, Alexion terminated its partnership with Moderna after safety issues prevented their work from reaching human trials.[23]

In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.[24] In December 2018, Moderna became a public company via the largest initial public offering of a biotechnology company in history, raising $621 million by selling 27 million shares at $23 per share.[25][26]

The first mRNA vaccine developed by Moderna was for influenza in 2015, and its first antibody encoded by mRNA was in 2019.[6] In 2023, Moderna acquired OriCiro Genomics, a Japanese manufacturer of genetic engineering tools, in its first acquisition.[27]

In early 2023, the company in collaboration with Merck won breakthrough status from the FDA for its mRNA-4157/V940 drug candidate, a cancer vaccine.[28][29]

In July 2023, the company entered into an agreement with the Chinese government to develop mRNA drugs for exclusive use in China.[30]

In May 2024, the mRNA vaccine Mresvia was approved for medical use in the United States by the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older,[31][32] the third RSV vaccine approved in the United States.

COVID-19 vaccine

Main article: Moderna COVID-19 vaccine

From 2020 to 2021, Moderna received $955 million from Operation Warp Speed to accelerate development of its COVID-19 vaccine, with $4.9 billion committed in total for producing 300 million vaccine doses.[33][34]

In March 2020, the Food and Drug Administration approved clinical trials for the Moderna COVID‑19 vaccine candidate, and in December, the vaccine, mRNA-1273, was issued an emergency use authorization in the United States.[35][36] In 2022, it gained FDA approval both for the monovalent vaccine, Spikevax, and a bivalent booster.[37]

In April 2022, Moderna announced plans to build a $180 million vaccine factory in Montreal, forming a 10-year partnership with the Government of Canada, Quebec, and McGill University to produce 100 million Spikevax doses annually and expand vaccine research capabilities.[38] The plant is scheduled to supply COVID-19 vaccines in the fall of 2025.[39]

In February 2023, the company agreed to pay $400 million to the National Institutes of Health, Dartmouth College, and Scripps Research to settle a dispute over the rights to a chemical technique that was used in the vaccine.[40]

Arbutus Biopharma filed a patent infringement lawsuit against Moderna in 2022, alleging that Arbutus developed lipid nanoparticles that enclose Modern'a vaccine's mRNA payload.[41] In April 2023, a court affirmed a decision to cancel a patent by Arbutus Biopharma in connection with the dispute.[42] In April 2024, however, the court issued an order that strengthened Arbutus's arguments by interpreting patents at issue in the manner Arbutus had urged.[41]

Several legal cases between Moderna and Pfizer and BioNTech in various countries, alleging that the Pfizer–BioNTech COVID-19 vaccine violates the patent on Moderna's mRNA vaccine technology, are ongoing.[43]

In November 2024, British pharmaceutical company GlaxoSmithKline (GSK) filed a lawsuit against Moderna Inc. in a U.S. federal court in Delaware, alleging that Moderna's COVID-19 vaccine Spikevax and RSV vaccine mResvia infringe on GSK’s patents related to messenger RNA (mRNA) technology. According to the complaint, Moderna's use of lipid nanoparticles—crucial for delivering fragile mRNA into the human body—violates several GSK patents covering similar delivery innovations.[44]

This lawsuit follows a similar legal action GSK brought against Pfizer and BioNTech earlier in 2024, claiming patent infringement over their mRNA-based COVID-19 vaccine. GSK’s latest litigation seeks unspecified monetary damages from Moderna.[44]

Rare disease therapeutics

Financial data

Year Revenue
(mln. US$) 		Net income (loss)
(mln. US$)
2019[1] 60 (514)
2020[1] 803 (747)
2021[1] 18,471 12,202
2022[1] 19,263 8,362
2023[1] 6,848 (4,710)

See also

References

  1. ^ a b c d e f g h i "Moderna, Inc., 2023, Form 10-K Annual Report". U.S. Securities and Exchange Commission. February 23, 2024.
  2. ^ "Moderna, Inc. Schedule 14A 2022 Proxy Statement". U.S. Securities and Exchange Commission. March 9, 2022.
  3. ^ "Key Facts". Moderna.
  4. ^ Moderna (October 23, 2019). mRNA-3704 and Methylmalonic Acidemia (video) – via YouTube.
  5. ^ Park KS, Sun X, Aikins ME, Moon JJ (December 2020). "Non-viral COVID-19 vaccine delivery systems". Advanced Drug Delivery Reviews. 169: 137–51. doi:10.1016/j.addr.2020.12.008. PMC 7744276. PMID 33340620.
  6. ^ a b c "Moderna, Our story; Our big moments". Moderna, Inc. 2023. Retrieved February 10, 2023.
  7. ^ a b Garde D, Saltzman J (November 10, 2020). "The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race". Stat. Archived from the original on November 10, 2020.
  8. ^ a b Servick K (March 25, 2020). "This mysterious $2 billion biotech is revealing the secrets behind its new drugs and vaccines (from the original, 1 February 2017)". Science. doi:10.1126/science.aal0686. S2CID 241466550.
  9. ^ Elton C (March 2013). "The NEXT Next Big Thing". Boston Magazine. Archived from the original on November 16, 2020.
  10. ^ a b Garde D (September 13, 2016). "Ego, ambition, and turmoil: Inside one of biotech's most secretive startups". Stat. Archived from the original on November 16, 2020.
  11. ^ "Moderna's Bancel Steps Down as Sales Chief, Keeps CEO Role". Bloomberg.com. November 5, 2024. Retrieved November 8, 2024.
  12. ^ Reidy C (January 13, 2014). "Alexion, Moderna announce agreement to develop messenger RNA therapeutics". Boston Globe Media Partners. Archived from the original on July 2, 2021. Retrieved June 5, 2023.
  13. ^ "Moderna Launches Onkaido Therapeutics to Focus on the Development of mRNA Therapeutics™ in Oncology with $20 Million Capital Commitment" (Press release). PR Newswire. January 14, 2014. Archived from the original on November 20, 2016.
  14. ^ Gormley B (January 15, 2014). "Moderna Launches Cancer Drug Co. Onkaido Therapeutics With $20M Investment". Wall Street Journal. ISSN 0099-9660. Archived from the original on June 5, 2023. Retrieved June 5, 2023.
  15. ^ "Moderna Launches New Venture Valera LLC for Infectious Diseases" (Press release). PR Newswire. January 8, 2015. Archived from the original on November 19, 2016.
  16. ^ "Moderna Launches New Venture Valera LLC for Infectious Diseases". Bionity. January 12, 2015. Archived from the original on June 5, 2023. Retrieved June 5, 2023.
  17. ^ Richner JM, Himansu S, Dowd KA, Butler SL, Salazar V, Fox JM, Julander JG, Tang WW, Shresta S, Pierson TC, Ciaramella G, Diamond MS (February 17, 2017). "Modified mRNA Vaccines Protect against Zika Virus Infection". Cell. 168 (6): 1114–1125.e10. doi:10.1016/j.cell.2017.02.017. ISSN 0092-8674. PMC 5388441. PMID 28222903.
  18. ^ "Moderna Launches Third Venture Company Elpidera for Rare Diseases" (Press release). PR Newswire. May 12, 2015. Archived from the original on October 12, 2016.
  19. ^ Tirrell M (May 12, 2015). "The biotech targeting personalized medicine". CNBC. Archived from the original on April 10, 2021. Retrieved June 5, 2023.
  20. ^ Weisman R (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Archived from the original on November 16, 2020.
  21. ^ "Moderna: Strategic collaborators". Moderna, Inc. 2023. Retrieved February 11, 2023.
  22. ^ "Vertex and Moderna hammer out $315 million+ deal to treat cystic fibrosis using mRNA technology". BioSpace. July 6, 2016. Retrieved February 11, 2023.
  23. ^ Garde D (July 27, 2017). "Key partner cuts ties with brash biotech startup Moderna, raising big questions about its pipeline". Stat.
  24. ^ DeAngelis A (July 17, 2018). "Moderna's $110M Norwood site built with expansion hopes". American City Business Journals.
  25. ^ Mukherjee S (December 8, 2018). "Moderna Had the Biggest Biotech IPO Ever. Here's What That Says About the Industry's Future". Fortune. Archived from the original on November 16, 2020.
  26. ^ Ramsey L (December 7, 2018). "Moderna just priced the biggest IPO in biotech history, valuing the startup at $7.5 billion". Business Insider. Archived from the original on November 16, 2020.
  27. ^ Schmidt H (January 5, 2023). "Moderna to Buy Japanese Firm OriCiro in Its First-Ever Acquisition". PharmaNews Intelligence.
  28. ^ "Precision medicine meets cancer vaccines". Nature Medicine. 29 (6): 1287. June 16, 2023. doi:10.1038/s41591-023-02432-2. PMID 37328586. S2CID 259184146.
  29. ^ Bafaloukos D (2023). "Evolution and Progress of mRNA Vaccines in the Treatment of Melanoma: Future Prospects". Vaccines. 11 (3): 636. doi:10.3390/vaccines11030636. PMC 10057252. PMID 36992220.
  30. ^ Kuchler H, Mancini DP (July 5, 2023). "US biotech Moderna strikes deal to develop mRNA drugs in China". Financial Times.
  31. ^ "Moderna Receives U.S. FDA Approval for RSV Vaccine Mresvia" (Press release). Moderna. May 31, 2024. Retrieved May 31, 2024 – via Accesswire.
  32. ^ "FDA Roundup: May 31, 2024". U.S. Food and Drug Administration (FDA) (Press release). May 31, 2024. Retrieved May 31, 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  33. ^ Valverde M (November 19, 2020). "How Pfizer's and Moderna's COVID-19 vaccines are tied to Operation Warp Speed". PolitiFact. Retrieved February 12, 2023.
  34. ^ Siddalingaiah SV (March 1, 2021). "Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials". Congressional Research Service, United States Government. Retrieved February 12, 2023.
  35. ^ "Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine". National Institutes of Health. December 18, 2020.
  36. ^ Ledford H (December 18, 2020). "Moderna COVID vaccine becomes second to get US authorization". Nature. doi:10.1038/d41586-020-03593-7. PMID 33340017. S2CID 243212854. Retrieved February 12, 2023.
  37. ^ "Moderna COVID-19 vaccines". US Food and Drug Administration. December 15, 2022. Retrieved February 11, 2023.
  38. ^ "Moderna facility in Montreal area expected to produce 100 million vaccine doses by 2024". CBC News. April 29, 2022.
  39. ^ "Moderna will supply COVID-19 vaccines made in Laval by fall 2025". The Gazette.
  40. ^ Mueller B (February 23, 2023). "After Long Delay, Moderna Pays N.I.H. for Covid Vaccine Technique". The New York Times.
  41. ^ a b "Moderna shares fall after judge sides with Arbutus in patent fight". Reuters. April 3, 2024. Retrieved May 19, 2024.
  42. ^ Brittain B (April 11, 2023). "Moderna fends off Arbutus appeal in COVID-19 vaccine patent fight". Reuters.
  43. ^ Robbins R, Gross J (August 26, 2022). "Moderna Sues Pfizer and BioNTech Over Covid Vaccine Technology". The New York Times. ISSN 0362-4331.
  44. ^ a b Brittain B (October 16, 2024). "GSK sues Moderna for US patent infringement over COVID, RSV vaccines". Reuters. Retrieved November 8, 2024.
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