Moderna

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Moderna, Inc.
FormerlyModeRNA Therapeutics
(2010–2018)
TypePublic
IndustryBiotechnology
FoundedSeptember 2010; 10 years ago (2010-09)
Founders
Headquarters200 Technology Square
Cambridge, Massachusetts, U.S.
Key people
ProductsVaccines
RevenueIncrease US$803 million (2020)
Negative increase US$−763 million (2020)
Negative increase US$−747 million (2020)
Total assetsIncrease US$7.336 billion (2020)
Total equityIncrease US$2.561 billion (2020)
OwnerNoubar Afeyan (12.7%)
Stéphane Bancel (7.9%)
Robert S. Langer (2.9%)
Stephen Hoge (1.3%)
Number of employees
1,300 (2020)
Websitemodernatx.com
Footnotes / references
[1][2][3][4][5][6][7]

Moderna, Inc (/məˈdɜːrnə/ mə-DUR-nə)[8] is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts. It focuses on vaccine technologies based on messenger RNA (mRNA).[1][9][10] Moderna's vaccine platform inserts synthetic nucleoside-modified messenger RNA (modRNA) into human cells using a coating of lipid nanoparticles. This mRNA then reprograms the cells to prompt immune responses.[11][12] Moderna develops mRNA therapeutic vaccines that are delivered in lipid nanoparticle, using mRNA with pseudouridine nucleosides. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis.[13]

The company's only commercial product is the Moderna COVID-19 vaccine. The company has 24 vaccine candidates, including vaccine candidates for seasonal flu, HIV, the Nipah virus, and a second COVID-19 vaccine that will be easier to store and administer than existing vaccines. In 2020, 65% of the company's revenues were from the Biomedical Advanced Research and Development Authority and 24% of the company's revenues were from other agencies of the Federal government of the United States.[1]

History[edit]

2010–2016[edit]

Moderna headquarters in Cambridge, Massachusetts

In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist Derrick Rossi. Rossi had 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.[14][15] Rossi approached fellow Harvard University faculty member Timothy A. Springer, who solicited co-investment from Kenneth R. Chien, Bob Langer, and venture capital firm Flagship Ventures, run by Noubar Afeyan.[15][16] Together they founded a company named from the combined terms "modified" and "RNA" that just happens to contain "modern".[17]

In 2011, Noubar Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO.[15][11]

Within 2 years of its founding, the company reached a unicorn valuation.[12]

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.[11][18][19] The agreement included a $240 million upfront payment to Moderna, a payment which was "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",[18] As of May 2020, only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled AZD8601.[a][21]

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.[22][23] In November 2013, the company raised $110 million of equity financing.[22]

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.[24] 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.[11][12]

2018–2020[edit]

In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.[10]

In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.[25][26]

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).[27][28][29]

Through year-end 2019, Moderna had accumulated losses of $1.5 billion since inception, with a loss of $514 million in 2019, and had raised $3.2 billion in equity since 2010.[10]

2020–2021: COVID-19 vaccine[edit]

Main article: Moderna COVID-19 vaccine
See also: COVID-19 vaccine and RNA vaccine
Vials of the Moderna COVID-19 vaccine

The Moderna COVID‑19 vaccine, codenamed mRNA-1273, is a COVID-19 vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). It is used in people aged 18 years and older to provide protection against infection by the SARS-CoV-2 virus, which causes COVID-19.[30][31] It is designed to be administered as two 0.5 mL doses given by intramuscular injection at an interval of four weeks apart.[32]

It is an RNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.

The Moderna COVID-19 vaccine is authorized for use at some level in 45 countries including the United States, Canada, the European Union, the United Kingdom, Israel, and Singapore.[33]

In March 2020, in a White House meeting between the Trump administration and pharmaceutical executives, Bancel told the president Moderna could have a COVID-19 vaccine ready in a few months.[10] The next day, the FDA approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483 million from Operation Warp Speed.[10] Moderna board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed project.[10]

In July 2020, the Moderna COVID-19 vaccine candidate, mRNA-1273, was shown in a Phase I trial to be immunogenic in a small number of volunteers aged 18–55 years.[34]

As of November 2020, Moderna planned to sell the vaccine for $32-37 per dose.[35]

Phase III clinical trials were completed in December 2020; the vaccine had not been licensed for prophylactic use against COVID-19, although the Moderna and Pfizer COVID-19 vaccines had been approved for marketing under emergency use authorizations from the FDA and regulatory agencies in other countries.[36][37]

In November 2020, it was announced that the Moderna COVID-19 vaccine candidate (codenamed mRNA-1273), had shown preliminary evidence of 94% efficacy in preventing COVID-19 in a Phase III trial,[38] with only minor flu-like side effects. This led to its submission for emergency use authorization (EUA) as a COVID-19 vaccine in Europe, the United States, and Canada.[39][40] On December 18, 2020, mRNA-1273 was issued an EUA in the United States.[41] On December 23, 2020, it was authorized for use in Canada.[42][43] On January 6, 2021, it was authorized for use in the European Union.[44] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.[45]

On March 15, 2021, Moderna's second COVID-19 vaccine (mRNA-1283) started phase I clinical trials.[46]

Company quotes[edit]

Moderna was selling itself as a "Personalized Cancer Vaccines" manufacturer and one journalist remarked on the "Army of Robots" in the new 200,000-square-foot manufacturing plant with "five fluorescently lit clinical clean rooms" they had recently commissioned that was necessary just for the pre-clinical research:

In the first room, large stainless steel machines turn a digital sequence of genetic building blocks called nucleotides into ring-shaped DNA plasmids. In the second, enzymes convert that DNA into strands of mRNA. In room three, the mRNA gets coated in lipid nanoparticles to help it enter cells. The last and most critical room is deep in the middle of the building, in a sealed-off aseptic block. To go there, employees have to don double layers of gowns and gloves, and move slowly so they don't stir up any microbes that might have slipped past air filters and sanitizing scrub-downs. Preventing contamination here is of utmost importance. It's where the mRNA gets deposited into the vials that will take them to their final destination. [The fifth room is] where the company plans to install a handful of refrigerator-sized, custom-designed robots for producing personalized cancer vaccines.

— Megan Molteni for Wired Magazine[26]

In 2018, the President of the company told a journalist of the planned personalised cancer vaccines that "It's not something that is like 'oh, this is the right color for you,' it's actually, 'no, we invented this color for you.'"[26]

Another well-regarded senior scientist who works for Moderna, Melissa Moore, predicted in 2018 that her team "is about to publish a paper showing they can engineer an off-switch into mRNAs, so they only express proteins in the cells Moderna wants them to, like, say, cancer cells".[26]

Criticism[edit]

In February 2016, a Nature editorial criticized Moderna for not publishing any peer-reviewed papers on its technology, unlike most other emerging and established biotech companies, and compared its approach to that of the controversially failed Theranos.[47] In September 2018, Thrillist published an article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[48] criticizing its reputation for secrecy and the absence of scientific validation or independent peer-review of its research, though having the highest valuation of any U.S. private biotech company at more than $5 billion.[11][49] A former Moderna scientist told Stat: "It's a case of the emperor's new clothes. They're running an investment firm, and then hopefully it also develops a drug that's successful."[11]

Conflict of interest of board member[edit]

In May 2020, Moderna board member Dr. Moncef Slaoui resigned from the company to become Chief Scientist for US's "Operation Warp Speed", a group designed to accelerate the development of a COVID-19 vaccine. Slaoui continued to hold more than $10 million in stock options in the company in his new role while the federal government invested $483 million in the company to assist in COVID-19 vaccine trials. Senator Elizabeth Warren called the holding a conflict of interest and said Slaoui should have divested his options.[50]

CEO[edit]

CEO Stéphane Bancel has been described as having a secretive approach to Moderna, and as being a tough operator.[11][10] Despite never having worked with RNA before, Stat noted that Bancel "is listed as a co-inventor on more than 100 of Moderna's early patent applications, unusual for a CEO who is not a PhD scientist".[11] After Noubar Afeyan and Robert Langer, Bancel is the largest individual shareholder in the company.[51]

See also[edit]

Notes[edit]

  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".[20]

References[edit]

  1. ^ a b c "Moderna, Inc. 2020 Form 10-K Annual Report". U.S. Securities and Exchange Commission.
  2. ^ "Moderna, Inc. SCHEDULE 14A 2021 Proxy Statement". U.S. Securities and Exchange Commission.
  3. ^ "What we know about Moderna's COVID-19 vaccine candidate—and what we don't". PBS News Hour. November 16, 2020. Archived from the original on December 4, 2020. Noubar Afeyan is a co-founder and chairman of Moderna ...
  4. ^ "Moderna chairman: We don't need deep-freeze conditions for vaccine". CNN. November 16, 2020. Archived from the original on December 4, 2020.
  5. ^ "Christmas comes early as first Moderna vaccines arrive in Canada". Global News. December 24, 2020.
  6. ^ Alspach, Kyle (May 22, 2013). "Moderna CEO Bancel joins Flagship Ventures as senior partner". American City Business Journals. Archived from the original on January 31, 2014.
  7. ^ "Key Facts". Moderna.
  8. ^ Moderna (October 23, 2019). mRNA-3704 and Methylmalonic Acidemia (Video) – via YouTube.
  9. ^ Shaffer, Catherine (December 6, 2013). "Moderna Makes Entrance with $40M Round for mRNA Work". BioWorld. Archived from the original on November 16, 2020.
  10. ^ a b c d e f g Cohen, Elizabeth (November 30, 2020). "Moderna applies for FDA authorization for its Covid-19 vaccine". CNN.
  11. ^ a b c d e f g h 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.
  12. ^ a b c 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.
  13. ^ Servick, Kelly (February 1, 2017). "This mysterious $2 billion biotech is revealing the secrets behind its new drugs and vaccines". Science. doi:10.1126/science.aal0686. Archived from the original on November 16, 2020.
  14. ^ 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.
  15. ^ 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.
  16. ^ Elton, Catherine (March 2013). "The NEXT Next Big Thing". Boston Magazine. Archived from the original on November 16, 2020.
  17. ^ 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.
  18. ^ 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.
  19. ^ Weisman, Robert (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Archived from the original on November 16, 2020.
  20. ^ "Moderna's gamble: what's behind biotech's biggest-ever IPO?". Pharmaceutical Technology. February 21, 2019. Archived from the original on November 16, 2020. Retrieved May 20, 2020.
  21. ^ "Our Pipeline". Moderna. Archived from the original on November 16, 2020. Retrieved May 19, 2020.
  22. ^ a b Timmerman, Luke (November 20, 2013). "Moderna Vacuums Up Another $110M to Make Messenger RNA Drugs". Xconomy.
  23. ^ 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.
  24. ^ 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.
  25. ^ DeAngelis, Allison (July 17, 2018). "Moderna's $110M Norwood site built with expansion hopes". American City Business Journals.
  26. ^ a b c d MOLTENI, Megan (July 25, 2018). "Making Personalized Cancer Vaccines Takes an Army—of Robots". Wired.
  27. ^ 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.
  28. ^ 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. Retrieved May 18, 2020.
  29. ^ "Moderna Announces Pricing of Initial Public Offering" (Press release). Business Wire. December 6, 2018.
  30. ^ "Moderna COVID-19 Vaccine – cx-024414 injection, suspension". DailyMed. Retrieved December 20, 2020.
  31. ^ "COVID-19 Vaccine Moderna EPAR". European Medicines Agency (EMA). Retrieved January 20, 2021.
  32. ^ "Moderna COVID-19 Vaccine". Dosing & Administration. Infectious Diseases Society of America. January 4, 2021. Retrieved January 5, 2021.
  33. ^ "COVID-19 Vaccine Tracker: Moderna: mRNA-1273". McGill University.
  34. ^ 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.
  35. ^ Kollewe, Julia (November 16, 2020). "Covid vaccine: who is behind the Moderna breakthrough?". The Guardian.
  36. ^ 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. doi:10.1016/s1473-3099(20)30923-3. ISSN 1473-3099. PMC 7832518. PMID 33306980.
  37. ^ Karim, Safura Abdool (December 18, 2020). "Emergency use authorization of Covid-19 vaccines could hinder global access to them". STAT.
  38. ^ Andersen, Karen (April 22, 2021). "Moderna's Innovation Still Building a Moat". Morningstar, Inc.
  39. ^ Burger, Ludwig (December 1, 2020). "COVID-19 vaccine sprint as Pfizer-BioNTech, Moderna seek emergency EU approval". Reuters.
  40. ^ Kuchler, Hannah (November 30, 2020). "Canada could be among the first to clear Moderna's COVID-19 vaccine for use". Financial Post.
  41. ^ "Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine". National Institutes of Health. December 18, 2020.
  42. ^ "Regulatory Decision Summary—Moderna COVID-19 Vaccine". Health Canada. December 23, 2020.
  43. ^ "Moderna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2)". COVID-19 vaccines and treatments portal. December 23, 2020. Retrieved December 23, 2020.
  44. ^ Strauss, Marine (January 6, 2021). "UPDATE 1-European Commission gives final approval to Moderna vaccine". Reuters.
  45. ^ "Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator" (Press release). gov.uk. January 8, 2021.
  46. ^ "First Participants Dosed in Phase 1 Study Evaluating mRNA-1283, Moderna's Next Generation COVID-19 Vaccine". Business Wire. March 15, 2021.
  47. ^ "Research not fit to print". Nature. 34 (115). February 5, 2016. Archived from the original on November 16, 2020. Retrieved May 19, 2020.
  48. ^ McGauley, Joe (September 23, 2018). "Why This Secretive Tech Start-Up Could Be The Next Theranos". Thrillist.
  49. ^ Crow, David (September 6, 2017). "Secretive Moderna yet to convince on $5bn valuation". Financial Times. Archived from the original on July 1, 2020.
  50. ^ Corcoran, Kieran (May 16, 2020). "The ex-pharma exec leading Trump's COVID-19 vaccine program has $10 million in stock options for a company getting federal funding". Business Insider. Archived from the original on November 16, 2020.
  51. ^ Wink, Ben (May 18, 2020). "Here are the 5 multimillionaire scientists and executives getting the richest off Moderna's spike to record highs". Business Insider. Archived from the original on November 16, 2020. Retrieved May 19, 2020.

External links[edit]

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