|Headquarters||200 Technology Square|
Cambridge, Massachusetts, U.S.
|Products||Moderna COVID-19 vaccine|
|Revenue||US$803 million (2020)|
|US$−763 million (2020)|
|US$−747 million (2020)|
|Total assets||US$7.336 billion (2020)|
|Total equity||US$2.561 billion (2020)|
|Owner||Noubar Afeyan (12.7%)|
Stéphane Bancel (7.9%)
Robert S. Langer (2.9%)
Stephen Hoge (1.3%)
Number of employees
|Footnotes / references|
Moderna, Inc., (// mə-DUR-nə) 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.
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.
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.
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.
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. Together they founded "ModeRNA Theraputics", named from the combined terms "modified" and "RNA" that just happens to contain "modern".
In 2011, Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO. Within 2 years of its founding, the company reached a unicorn valuation. In December 2012, the company raised $40 million.
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. 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". 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.
In November 2013, the company raised $110 million of equity financing.
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. 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.
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.
2018–2019: Initial public offering
In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.
Through year-end 2019, Moderna had accumulated losses of $1.5 billion since inception, with a loss of $514 million in 2019.
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. Moncef Slaoui, then a member of the board of directors of Moderna, was appointed head scientist for the Operation Warp Speed project.
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. 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.
On December 18, 2020, mRNA-1273 was issued an emergency use authorization (EUA) in the United States. On December 23, 2020, it was authorized for use in Canada. On January 6, 2021, it was authorized for use in the European Union. On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.
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.
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.
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.
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. 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. The Stat article was summarized by Thrillist shortly thereafter. However, as clinical trials got underway in 2017, the company became more open and claimed that it did not publish more data earlier "for competitive reasons".
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.
- 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".
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Noubar Afeyan is a co-founder and chairman of Moderna.
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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.
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