شركة مودرنا

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

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

Moderna, Inc.
سابقاً
ModeRNA Therapeutics
(2010–2018)
النوعPublic
رمز التداول
ISINUS60770K1079
الصناعةBiotechnology
تأسستسبتمبر 2010; 14 years ago (2010-09
المؤسس
المقر الرئيسي200 Technology Square
Cambridge, Massachusetts, U.S.
الأشخاص الرئيسيون
المنتجاتVaccines
الدخل▲ US$803 million (2020)
ربح العمليات▲ US$−763 million (2020)
▲ US$−747 million (2020)
إجمالي الأصول▲ US$7.336 billion (2020)
إجمالي الأنصبة▲ US$2.561 billion (2020)
المالكNoubar Afeyan (12.7%)
Stéphane Bancel (7.9%)
Robert S. Langer (2.9%)
Stephen Hoge (1.3%)
الموظفون1,500+ (2021)
الموقع الإلكترونيmodernatx.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 nanoparticles, 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 influenza, 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]

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History

2010–2016

In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist Derrick Rossi. Rossi had discovered the works of Hungarian biochemist Katalin Karikó on RNA-mediated immune activation, which resulted in the co-discovery with American immunologist Drew Weissman of the nucleoside modifications that suppress the immunogenicity of RNA. This technology would later be licensed and used by Moderna and BioNTech to develop COVID-19 vaccines.[14]

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.[15][16] 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.[16][17] Together they founded a company named from the combined terms "modified" and "RNA" that just happens to contain "modern".[18]

In 2011, Noubar Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO.[16][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][19][20] 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",[19] اعتبارا من May 2020, only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled AZD8601.[أ][22]

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.[23][24] In October 2013, the company was awarded up to $25 million by DARPA to develop messenger RNA therapeutics.[25] In November 2013, the company raised $110 million of equity financing.[23]

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.[26] 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]

2017

In November 2017, the mRNA technology was safety-tested by Maja Sedic and her colleagues in Sprague-Dawley rats and cynomolgus monkeys at the Montreal and Sherbrooke facilities of Charles River Laboratories. They found, inter alia, 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.[27]

2018–2020

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.[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, and had raised $3.2 billion in equity since 2010.[10]

2020–2021: COVID-19 vaccine

المقالة الرئيسية: Moderna COVID-19 vaccine
انظر أيضاً: COVID-19 vaccine and RNA vaccine
أمبولات من لقاح مودرنا المضاد لكوڤيد-19.

لقاح مودرنا المضاد لكوڤيد-19 (إنگليزية: Moderna COVID-19 Vaccine، يحمل الرمز mRNA-1273)، هو أحد لقاحات كوڤيد-19، طوره المعهد الوطني للحساسية والأمراض المعدية، وهيئة البحث والتطوير الطبي الحيوي المتقدم، وشركة مودرنا. تم تصميمه ليتم إعطاؤه كجرعتين 0.5 مل عن طريق الحقن العضلي بفاصل 29 يومًا على حدة.[33]

هو لقاح رنا يتكون من مرسال الرنا معدل بالنيكليوزيد (modRNA) ويشفر البروتين الشوكي لسارس كوڤ-2، المغلف في جزيئات الدهون النانوية. وهو أحد لقاحين الرنا تم تطويرهما وطرحهما في عام 2020 ضد كوڤيد-19، والآخر هو لقاح لقاح فايزر-بيون‌تك

في 18 ديسمبر 2020، حصل لقاح mRNA-1273 على ترخيص من قبل إدارة الغذاء والدواء الأمريكية (FDA).[34][35][36][37] حصل على ترخيص للاستخدام في كندا في 23 ديسمبر 2020,[38][39] في الاتحاد الأوروبي في 6 يناير 2021,[40][41][42] وفي المملكة المتحدة في 8 يناير 2021.[43]

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.[44]

As of November 2020, Moderna planned to sell the vaccine for $32-37 per dose.[45]

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.[46][47]

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,[48] 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.[49][50] On December 18, 2020, mRNA-1273 was issued an EUA in the United States.[51] On December 23, 2020, it was authorized for use in Canada.[52][53] On January 6, 2021, it was authorized for use in the European Union.[54] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.[55] Instead of relying on a large pharmaceutical company, Moderna made a strategic deal with Swiss contract manufacturer Lonza[56] with a very flexible goal of producing between 500m and 1bn doses in 2021.[57]

On March 15, 2021, Moderna's second COVID-19 vaccine (mRNA-1283) was entered into Phase I clinical trials.[58]

On 25 June 2021, the US Food and Drug Administration (FDA) added a warning about rare cases of heart inflammation (myocarditis) associated with both Moderna and Pfizer/BioNTech vaccines to their respective fact sheets. As of that date, there were already 138 million US citizens who had been vaccinated twice with one of the mRNA-based vaccines, according to the US Centers for Disease Control and Prevention (CDC).[59][60]

On 17 August 2021, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Moderna’s Covid vaccine for use in children aged 12 to 17 years.[61]

2021

July 2021, phase 1 clinical study of influenza vaccine begins, code name mRNA-1010.[62][63]

August 2021, the company received US FDA fast track designation for respiratory syncytial virus (RSV) vaccine.[64]

Criticism

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.[65] In September 2018, Thrillist published an article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[66] 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][67] 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]

Board member conflict of interest

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.[68]


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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

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External links

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