Moderna

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Moderna, Inc.
FormerlyModeRNA Therapeutics
(2010–2018)
TypePublic
ISINUS60770K1079
IndustryBiotechnology
FoundedSeptember 2010; 11 years ago (2010-09)
Founders
Headquarters200 Technology Square
Cambridge, Massachusetts, U.S.
Key people
ProductsModerna COVID-19 vaccine
Vaccine candidates
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
1,800+ (2021)
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 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.[9][1]

The company's only commercial product is the Moderna COVID-19 vaccine. The company has 23 treatment and vaccine candidates, of which 15 have entered clinical trials. 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: Preface

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.[10][11]

In 2007, Rossi set out to build on their findings as a new assistant professor at Harvard Medical School running his own lab.[10]

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.[12][13]

2010–2016

In 2010, Rossi approached fellow Harvard University faculty member Timothy A. Springer, who solicited co-investment from Kenneth R. Chien, Bob Langer, and Venture Studio Flagship Ventures, run by Noubar Afeyan.[13][14] Together they founded "ModeRNA Theraputics", named from the combined terms "modified" and "RNA" that just happens to contain "modern".[15]

In 2011, Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO.[13][16] Within 2 years of its founding, the company reached a unicorn valuation.[17] In December 2012, the company raised $40 million.[18]

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.[16][19][20] 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".[19] 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.[22][23]

In October 2013, the company was awarded up to $25 million by DARPA to develop messenger RNA therapeutics.[24]

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.[25] 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.[16][17]

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.[26]

2018–2019: Initial public offering

In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.[27]

In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.[28][29]

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).[30][31][32]

Through year-end 2019, Moderna had accumulated losses of $1.5 billion since inception, with a loss of $514 million in 2019.[33]

2020–2021: COVID-19 vaccine

The Moderna COVID‑19 vaccine, codenamed mRNA-1273 and sold under the brand name Spikevax, is a COVID-19 vaccine developed by Moderna, the US National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA).

In March 2020, the Food and Drug Administration (FDA) approved clinical trials for the Moderna vaccine candidate, with Moderna receiving investment of $483 million from Operation Warp Speed.[27] Moncef Slaoui, then a member of the board of directors of Moderna, was appointed head scientist for the Operation Warp Speed project.[27]

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.[34]

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.[35] 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.[36]

On December 18, 2020, mRNA-1273 was issued an emergency use authorization (EUA) in the United States.[37][38][39][27] On December 23, 2020, it was authorized for use in Canada.[40][41][42] On January 6, 2021, it was authorized for use in the European Union.[43][44] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.[45]

Moderna partnered with Swiss contract manufacturer Lonza Group to produce as much as 1 billion doses in 2021.[46]

On March 15, 2021, Phase I clinical trials began for mRNA-1283, primarily intended to be used as a COVID-19 vaccine booster.[47]

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.[48][49]

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.[50][51][52]

2021: Other vaccine candidates

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.[53]

In July 2021, the company's mRNA vaccine for influenza, code name mRNA-1010, entered Phase I clinical trials.[54]

In August 2021, the company received fast track designation from the Food and Drug Administration for its respiratory syncytial virus vaccine.[55]

In September 2021, the company began work on a combined COVID-19 vaccine booster and influenza vaccine.[56]

Criticism

Secretive research before 2017

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.[57] In September 2016, Stat published an article criticizing the company's reputation for secrecy and the absence of scientific validation or independent peer review of its research, despite it then having the highest valuation of any U.S. private biotech company of over $5 billion.[16] The Stat article was summarized by Thrillist shortly thereafter.[58] However, as clinical trials got underway in 2017, the company became more open[59] and claimed that it did not publish more data earlier "for competitive reasons".[60]

Board member conflict of interest

In May 2020, Moncef Slaoui resigned from the board of directors of the company to become Chief Scientist for "Operation Warp Speed", a United States 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.[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".[21]

References

  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. March 10, 2021.
  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. ^ Connolly, Amanda (December 24, 2020). "Christmas comes early as first Moderna vaccines arrive in Canada". Global News.
  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. ^ 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.
  10. ^ a b Garde, Damian (November 10, 2020). "The story of mRNA: From a loose idea to a tool that may help curb Covid". STAT.
  11. ^ Kollewe, Julia (November 16, 2020). "Covid vaccine: who is behind the Moderna breakthrough?". The Guardian.
  12. ^ 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.
  13. ^ 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.
  14. ^ Elton, Catherine (March 2013). "The NEXT Next Big Thing". Boston Magazine. Archived from the original on November 16, 2020.
  15. ^ 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.
  16. ^ a b c d 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.
  17. ^ 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.
  18. ^ Shaffer, Catherine (December 6, 2013). "Moderna Makes Entrance with $40M Round for mRNA Work". BioWorld. Archived from the original on November 16, 2020.
  19. ^ 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.
  20. ^ Weisman, Robert (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Archived from the original on November 16, 2020.
  21. ^ Cross, Ryan (February 20, 2019). "Moderna and AstraZeneca's mRNA therapy for heart regeneration passes Phase I safety test". American Chemical Society.
  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. ^ "DARPA Awards Moderna Therapeutics a Grant for up to $25 Million to Develop Messenger RNA Therapeutics". October 2, 2013.
  25. ^ 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.
  26. ^ 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.
  27. ^ a b c d Cohen, Elizabeth (November 30, 2020). "Moderna applies for FDA authorization for its Covid-19 vaccine". CNN.
  28. ^ DeAngelis, Allison (July 17, 2018). "Moderna's $110M Norwood site built with expansion hopes". American City Business Journals.
  29. ^ MOLTENI, Megan (July 25, 2018). "Making Personalized Cancer Vaccines Takes an Army—of Robots". Wired.
  30. ^ 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.
  31. ^ 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.
  32. ^ "Moderna Announces Pricing of Initial Public Offering" (Press release). Business Wire. December 6, 2018.
  33. ^ "mrna-20200630". www.sec.gov. Retrieved December 4, 2021.
  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. ^ "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.
  36. ^ "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.
  37. ^ 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.
  38. ^ Karim, Safura Abdool (December 18, 2020). "Emergency use authorization of Covid-19 vaccines could hinder global access to them". STAT.
  39. ^ "Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine". National Institutes of Health. December 18, 2020.
  40. ^ "Regulatory Decision Summary—Moderna COVID-19 Vaccine". Health Canada. December 23, 2020.
  41. ^ "Moderna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2)". Government of Canada. December 23, 2020.
  42. ^ Kuchler, Hannah (November 30, 2020). "Canada could be among the first to clear Moderna's COVID-19 vaccine for use". Financial Post.
  43. ^ Strauss, Marine (January 6, 2021). "UPDATE 1-European Commission gives final approval to Moderna vaccine". Reuters.
  44. ^ Burger, Ludwig (December 1, 2020). "COVID-19 vaccine sprint as Pfizer-BioNTech, Moderna seek emergency EU approval". Reuters.
  45. ^ "Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator" (Press release). gov.uk. January 8, 2021.
  46. ^ Kuchler, Hannah (November 7, 2020). "Moderna's Covid vaccine offers vindication of its unconventional approach". Financial Times.
  47. ^ "First Participants Dosed in Phase 1 Study Evaluating mRNA-1283, Moderna's Next Generation COVID-19 Vaccine". Business Wire. March 15, 2021.
  48. ^ "Coronavirus (COVID-19) Update: June 25, 2021" (Press release). Food and Drug Administration. June 25, 2021.
  49. ^ "FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots". Reuters. June 26, 2021.
  50. ^ Quinn, Ben (August 17, 2021). "UK regulator approves Moderna Covid vaccine for older children". The Guardian.
  51. ^ Shabong, Yadarisa; Mishra, Manas (August 17, 2021). "UK regulator approves Moderna COVID-19 shot for 12 to 17-year-olds". Reuters.
  52. ^ Coles, Amy (August 17, 2021). "COVID-19: UK regulator approves Moderna coronavirus vaccine for 12 to 17-year-olds". Sky News.
  53. ^ Clinical trial number NCT03948763 for "A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)" at ClinicalTrials.gov
  54. ^ Tarantola, Andrew (July 7, 2021). "Moderna enters clinical trials for its mRNA-based flu vaccine". Engadget.
  55. ^ "Moderna Receives FDA Fast Track Designation for Respiratory Syncytial Virus (RSV) Vaccine (mRNA-1345)" (Press release). Business Wire. August 3, 2021.
  56. ^ Erman, Michael; Maddipatla, Manojna (September 9, 2021). "Moderna working on combination COVID-19 vaccine booster and flu shot". Reuters.
  57. ^ "Research not fit to print". Nature. 34 (115). February 5, 2016. Archived from the original on November 16, 2020.
  58. ^ McGauley, Joe (September 23, 2016). "Why This Secretive Tech Start-Up Could Be The Next Theranos". Thrillist.
  59. ^ 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. S2CID 241466550. Archived from the original on November 16, 2020.
  60. ^ Crow, David (September 6, 2017). "Secretive Moderna yet to convince on $5bn valuation". Financial Times. Archived from the original on July 1, 2020.
  61. ^ 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.

External links

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