Moderna

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

Moderna, Inc.
FormerlyModeRNA Therapeutics
(2010–2018)
TypePublic
ISINUS60770K1079
IndustryBiotechnology
FoundedSeptember 2010; 12 years ago (2010-09)
Founders
Headquarters200 Technology Square
Cambridge, Massachusetts, U.S.
Key people
ProductsSpikevax
Vaccine candidates
RevenueIncrease US$18.5 billion (2021)
Increase US$13.3 billion (2021)
Increase US$12.2 billion (2021)
Total assetsIncrease US$24.7 billion (2021)
Total equityIncrease US$14.1 billion (2021)
OwnerStéphane Bancel (7.8%)
Noubar Afeyan (5.0%)
Robert S. Langer (2.9%)
Stephen Hoge (1.3%)
Number of employees
2,700 (2021)
Websitewww.modernatx.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 produce an immune response.[5][1]

The company's only commercial product is the Moderna COVID-19 vaccine, marketed as Spikevax. As of 2022, the company has 44 treatment and vaccine candidates, of which 21 have entered clinical trials. Targets for vaccine candidates include influenza, HIV, respiratory syncytial virus, Epstein–Barr virus, the Nipah virus, chikungunya, a combined single-shot COVID-19 booster and influenza vaccine, a cytomegalovirus vaccine, and two cancer vaccines. The company's pipeline also includes candidates for cancer immunotherapy using OX40 ligand, interleukin 23, IL36G, and interleukin 12 as well as, in partnership with AstraZeneca, a regenerative medicine treatment that encodes vascular endothelial growth factor A to stimulate blood vessel growth for patients with myocardial ischemia.[1]

History

2005–2009

In 2005, Derrick Rossi, a 39-year-old postdoctoral fellow in stem cell biology at Stanford University, studied a paper by Hungarian biochemist Katalin Karikó on RNA-mediated immune activation and her co-discovery with American immunologist Drew Weissman of the nucleoside modifications that suppress the immunogenicity of RNA.[6][7]

In 2007, Rossi set out to build on their findings as a new assistant professor at Harvard Medical School running his own lab.[6]

Rossi developed a method of modifying mRNA first via transfection into human cells, then dedifferentiating it into bone marrow stem cells which could then be further differentiated into desired target cell types.[8][9]

2010

In 2010, Rossi solicited investment from fellow Harvard University faculty member and serial entrepreneur Timothy A. Springer. Springer invested $5 million in the company[10] and solicited additional investments from Kenneth R. Chien, Bob Langer, and Venture Studio Flagship Ventures, run by Noubar Afeyan.[9][11] Together they founded "ModeRNA Therapeutics", named from the combined terms "modified" and "RNA" that just happens to contain "modern".[12]

2011

In 2011, Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO.[9][13]

2012

Within 2 years of its founding, the company reached a unicorn valuation.[14] Patrick Degorce, founder of Theleme Partners, invested in Moderna and provided a $500,000 grant to allow the company to recruit a pair of oncologists.[15] In December 2012, the company raised $40 million.[16]

2013

In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop, and commercialize mRNA for treatments in the therapeutic areas of cardiovascular, metabolic, and renal diseases, and selected targets for cancer.[13][17][18] The agreement included a $240 million upfront payment to Moderna, "one of the largest ever initial payments in a pharmaceutical industry licensing deal that does not involve a drug already being tested in clinical trials".[17] Only one candidate from this partnership has passed Phase I trials, AZD8601, a regenerative medicine treatment which encodes vascular endothelial growth factor A to stimulate blood vessel growth for patients with myocardial ischemia undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function.[a]

In September 2013, the company reported that it was able to improve heart function in mice and enhance their long-term survival with a "redirection of their [stem cell] differentiation toward cardiovascular cell types" in a significant step for regenerative medicine.[20][21]

In October 2013, the company was awarded up to $25 million by DARPA to develop messenger RNA therapeutics.[22]

In November 2013, the company raised $110 million of equity financing.[20]

2014

In January 2014, Alexion Pharmaceuticals paid Moderna $100 million for ten product options to develop rare disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform.[23] Although CEO Bancel expected the platform to enter human trials in 2016, the program with Alexion was scrapped in January 2017 after animal trials showed that Moderna's treatment would never be safe enough for humans.[13][14]

2017

In November 2017, Moderna employees safely tested mRNA technology in Sprague-Dawley rats and cynomolgus monkeys at the Montreal and Sherbrooke facilities of Charles River Laboratories. They found, among other things, that "mRNA is a labile biological molecule and therefore requires the use of protective delivery systems to effectively harness its potential," as the mRNA spread beyond the injection site and was found in the liver, spleen, bone marrow and heart.[24]

2018

In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.[25]

In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.[26][27]

In December 2018, Moderna became a public company via the largest biotech initial public offering in history, raising $621 million (27 million shares at $23 per share).[28][29][30]

2019

In May 2019, the company together with Merck Sharp & Dohme, entered a Phase I clinical trial for mRNA-5671 vaccine in combination with pembrolizumab for the treatment of solid tumors with driver mutations in the KRAS gene.[31]

2020

In March 2020, the Food and Drug Administration (FDA) approved clinical trials for the Moderna COVID‑19 vaccine candidate, with Moderna receiving investment of $483 million from Operation Warp Speed.[25] Moncef Slaoui, then a member of the board of directors of Moderna, was appointed head scientist for the Operation Warp Speed project.[25]

In July 2020, the Moderna COVID-19 vaccine candidate was shown to be immunogenic in a Phase I trial involving 45 volunteers aged 18–55 years.[32]

On November 16, 2020, an interim analysis of Phase III clinical trials, which involved over 30,000 patients, showed that the Moderna COVID-19 vaccine candidate was 94.1% effective in preventing COVID-19 with only minor flu-like side effects.[33] The trials were completed on November 30, 2020, which confirmed the interim results and that the vaccine candidate was 100% effective in preventing severe cases of COVID-19.[34]

On December 18, 2020, mRNA-1273 was issued an emergency use authorization (EUA) in the United States.[35][36][37][25] On December 23, 2020, it was authorized for use in Canada.[38][39][40] On January 6, 2021, it was authorized for use in the European Union.[41][42] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.[43]

Moderna partnered with Swiss contract manufacturer Lonza Group to produce the vaccine.[44]

2021

On March 15, 2021, Phase I clinical trials began for mRNA-1283, primarily intended to be used as a COVID-19 vaccine booster.[45]

On June 25, 2021, the Food and Drug Administration added a warning about rare cases of myocarditis, a heart inflammation, associated with both Moderna and Pfizer/BioNTech vaccines to their respective fact sheets.[46][47]

On August 17, 2021, the United Kingdom's Medicines and Healthcare products Regulatory Agency approved Moderna's Covid vaccine for use in children aged 12 to 17 years.[48][49][50]

In July 2021, the company's mRNA vaccine for influenza, code name mRNA-1010, entered Phase I clinical trials.[51]

In August 2021, the company received fast track designation from the Food and Drug Administration for its respiratory syncytial virus vaccine.[52]

In September 2021, the company began work on a combined COVID-19 vaccine booster and influenza vaccine.[53] That same month, it entered an agreement with biomanufacturing company National Resilience to manufacture genetic components for its COVID-19 products at its facility in Mississauga, Ontario.[54]

2022

On April 7, 2022, Moderna and the University of Toronto announced a new partnership to “develop new tools to prevent and treat infectious diseases,” including in the realms of “molecular genetics, biomedical engineering, and biochemistry.[55][56] The collaboration is a joint venture across U of T's Faculties of Applied Science and Engineering and Medicine.

In April 2022, Moderna announced plans to build a $180 million vaccine factory in Montreal, forming a 10-year partnership with the Canadian federal government, province of Quebec, and McGill University to produce 100 million Spikevax doses annually and expand vaccine research capabilities.[57]

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

NIH vaccine patent dispute

Moderna is involved in a patent dispute with the NIH over its COVID-19 vaccine.[58] According to the NIH, three of its scientists played a major role in developing the vaccine over four years of collaboration.[59][60] After first refuting the shared patent application entirely, Moderna postponed the final payment for filing the application, thereby leaving the patent application unfiled as of December 2021.[60]

Pfizer and BioNTech patent lawsuits

On August 26, 2022, Moderna sued Pfizer and BioNTech in both Massachusetts and Germany, accusing the Pfizer–BioNTech COVID-19 vaccine of violating the patent on Moderna's mRNA vaccine technology.[61]

See also

Notes

  1. ^ The relative success of AZD8601 is attributed to the fact that Moderna has been able to inject mRNA direct into the heart muscle without needing a drug delivery system. However, only the heart and some skin areas are capable of absorbing "naked mRNA".[19]

References

  1. ^ a b c d e f "Moderna, Inc., 2021, Form 10-K Annual Report" (PDF). U.S. Securities and Exchange Commission.
  2. ^ "Moderna, Inc. Schedule 14A 2021 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 Garde, Damian (November 10, 2020). "The story of mRNA: From a loose idea to a tool that may help curb Covid". STAT.
  7. ^ Kollewe, Julia (November 16, 2020). "Covid vaccine: who is behind the Moderna breakthrough?". The Guardian.
  8. ^ Kutz, Erin (October 4, 2010). "ModeRNA, Stealth Startup Backed By Flagship, Unveils New Way to Make Stem Cells". Xconomy. Archived from the original on February 8, 2017.
  9. ^ a b c Huang, Gregory (December 6, 2012). "Moderna, $40M in Tow, Hopes to Reinvent Biotech with "Make Your Own Drug"". Xconomy. Archived from the original on November 22, 2018.
  10. ^ Tognini, Giacomo (May 16, 2020). "THE CHANGING FORTUNES OF THE WORLD'S RICHEST". Forbes.
  11. ^ Elton, Catherine (March 2013). "The NEXT Next Big Thing". Boston Magazine. Archived from the original on November 16, 2020.
  12. ^ Garde, Damian; Saltzman, Jonathan (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.
  13. ^ a b c Garade, Damien (September 13, 2016). "Ego, ambition, and turmoil: Inside one of biotech's most secretive startups". Stat. Archived from the original on November 16, 2020.
  14. ^ a b Garde, Damien (January 10, 2017). "Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine". Stat. Archived from the original on November 16, 2020.
  15. ^ Chung, Juliet. "The Millionaire Who Gave Moderna a Shot". WSJ. Retrieved October 27, 2022.
  16. ^ Shaffer, Catherine (December 6, 2013). "Moderna Makes Entrance with $40M Round for mRNA Work". BioWorld. Archived from the original on November 16, 2020.
  17. ^ a b Pollack, Andrew (March 21, 2013). "AstraZeneca Makes a Bet on an Untested Technique". The New York Times. Archived from the original on November 16, 2020.
  18. ^ Weisman, Robert (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Archived from the original on November 16, 2020.
  19. ^ Cross, Ryan (February 20, 2019). "Moderna and AstraZeneca's mRNA therapy for heart regeneration passes Phase I safety test". American Chemical Society.
  20. ^ a b Timmerman, Luke (November 20, 2013). "Moderna Vacuums Up Another $110M to Make Messenger RNA Drugs". Xconomy.
  21. ^ Zangi, Lior; Lui, Kathy O.; von Gise, Alexander; Ma, Qing; Ebina, Wataru; Ptaszek, Leon M.; Später, Daniela; Xu, Huansheng; Tabebordbar, Mohammadsharif; Gorbatov, Rostic; Sena, Brena; Nahrendorf, Matthias; Briscoe, David M.; Li, Ronald A.; Wagers, Amy J.; Rossi, Derrick J.; Pu, William T.; Chien, Kenneth R. (September 8, 2013). "Modified mRNA directs the fate of heart progenitor cells and induces vascular regeneration after myocardial infarction". Nature Biotechnology. 31 (10): 898–907. doi:10.1038/nbt.2682. PMC 4058317. PMID 24013197.
  22. ^ "DARPA Awards Moderna Therapeutics a Grant for up to $25 Million to Develop Messenger RNA Therapeutics". October 2, 2013.
  23. ^ Reidy, Chris (January 13, 2014). "Alexion, Moderna announce agreement to develop messenger RNA therapeutics". The Boston Globe. Archived from the original on November 16, 2020.
  24. ^ Sedic M, Senn JJ, Lynn A, Laska M, Smith M, Platz SJ, Bolen J, Hoge S, Bulychev A, Jacquinet E, Bartlett V, Smith PF (March 2018). "Safety Evaluation of Lipid Nanoparticle-Formulated Modified mRNA in the Sprague-Dawley Rat and Cynomolgus Monkey". Vet Pathol. 55 (2): 341–354. doi:10.1177/0300985817738095. PMID 29191134. S2CID 206512551.
  25. ^ a b c d Cohen, Elizabeth (November 30, 2020). "Moderna applies for FDA authorization for its Covid-19 vaccine". CNN.
  26. ^ DeAngelis, Allison (July 17, 2018). "Moderna's $110M Norwood site built with expansion hopes". American City Business Journals.
  27. ^ MOLTENI, Megan (July 25, 2018). "Making Personalized Cancer Vaccines Takes an Army—of Robots". Wired.
  28. ^ Mukherjee, Sy (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.
  29. ^ Ramsey, Lydia (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.
  30. ^ "Moderna Announces Pricing of Initial Public Offering" (Press release). Business Wire. December 6, 2018.
  31. ^ Clinical trial number NCT03948763 for "A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)" at ClinicalTrials.gov
  32. ^ Jackson, Lisa A.; Anderson, Evan J.; Rouphael, Nadine G.; Roberts, Paul C.; Makhene, Mamodikoe; Coler, Rhea N.; McCullough, Michele P.; Chappell, James D.; Denison, Mark R.; Stevens, Laura J.; Pruijssers, Andrea J. (July 14, 2020). "An mRNA Vaccine against SARS-CoV-2—Preliminary Report". New England Journal of Medicine. 383 (20): 1920–1931. doi:10.1056/NEJMoa2022483. ISSN 0028-4793. PMC 7377258. PMID 32663912. At the 100-microgram dose, the one Moderna is advancing into larger trials, all fifteen patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection. All side effects were considered mild or moderate. A higher, 250-microgram dose led to more serious reactions and has been set aside.
  33. ^ "Moderna's COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study" (Press release). Moderna. November 16, 2020.
  34. ^ "Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization" (Press release). Moderna. November 30, 2020. Archived from the original on November 30, 2020. Retrieved October 31, 2021.
  35. ^ Singh, Jerome Amir; Upshur, Ross E. G. (December 8, 2020). "The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials". The Lancet. 21 (4): e103–e109. doi:10.1016/s1473-3099(20)30923-3. ISSN 1473-3099. PMC 7832518. PMID 33306980.
  36. ^ Karim, Safura Abdool (December 18, 2020). "Emergency use authorization of Covid-19 vaccines could hinder global access to them". STAT.
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  39. ^ "Moderna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2)". Government of Canada. December 23, 2020.
  40. ^ Kuchler, Hannah (November 30, 2020). "Canada could be among the first to clear Moderna's COVID-19 vaccine for use". Financial Post.
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External links