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 $240million 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 PhaseI 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.[lower-alpha 1]
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 $25million by DARPA to develop messenger RNA therapeutics.[24]
In November 2013, the company raised $110million of equity financing.[22]
In January 2014, Alexion Pharmaceuticals paid Moderna $100million 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, 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, 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 March 2020, in a White House meeting between the Trump administration and pharmaceutical executives, Bancel stated that Moderna could have a COVID-19 vaccine ready in a few months.[27] The next day, the Food and Drug Administration (FDA) approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483million 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 PhaseI trial involving 45 volunteers aged 18–55 years.[33]
On November 16, 2020, an interim analysis of PhaseIII 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.[34] 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.[35]
On December 18, 2020, mRNA-1273 was issued an emergency use authorization (EUA) in the United States.[36][37][38][27] On December 23, 2020, it was authorized for use in Canada.[39][40][41] On January 6, 2021, it was authorized for use in the European Union.[42][43] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom .[44]
Moderna partnered with Swiss contract manufacturer Lonza Group to produce as much as 1 billion doses in 2021.[45]
On March 15, 2021, Phase I clinical trials began for mRNA-1283, primarily intended to be used as a COVID-19 vaccine booster.[46]
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.[47][48]
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.[55] In September 2018, Thrillist published an article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[56] 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 the time of over $5billion.[16][57] This was reinforced by a former Moderna scientist in an article published by Stat.[16] However, as clinical trials got underway in 2017, the company became more open.[58]
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 $10million in stock options in the company in his new role, while the federal government invested $483million 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.[59]
↑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]
↑"Safety Evaluation of Lipid Nanoparticle-Formulated Modified mRNA in the Sprague-Dawley Rat and Cynomolgus Monkey". Vet Pathol55 (2): 341–354. March 2018. doi:10.1177/0300985817738095. PMID29191134.
↑Jackson, Lisa A.; Anderson, Evan J.; Rouphael, Nadine G.; Roberts, Paul C.; Makhene, Mamodikoe; Coler, Rhea N.; McCullough, Michele P.; Chappell, James D. et al. (July 14, 2020). "An mRNA Vaccine against SARS-CoV-2—Preliminary Report". New England Journal of Medicine383 (20): 1920–1931. doi:10.1056/NEJMoa2022483. ISSN0028-4793. PMID32663912. "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.".