Moderna

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.[6][7]

In 2007, Rossi set out to build on their findings as a new assistant professor at Harvard Medical School running his own lab.[6]

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.[8][9]

In 2010, Rossi solicited investment from fellow Harvard University faculty member and serial entrepreneur Timothy A. Springer. Springer invested $5 million in the company[10] and solicited additional investments from Kenneth R. Chien, Bob Langer, and Venture Studio Flagship Ventures, run by Noubar Afeyan.[9][11] Together they founded "ModeRNA Therapeutics", named from the combined terms "modified" and "RNA" that just happens to contain "modern".[12]

In 2011, Afeyan, the largest shareholder of Moderna, hired Stéphane Bancel, previously an executive at BioMérieux and Eli Lilly and Company, as CEO.[9][13]

Within 2 years of its founding, the company reached a unicorn valuation.[14] Patrick Degorce, founder of Theleme Partners, invested in Moderna and provided a $500,000 grant to allow the company to recruit a pair of oncologists.[15] In December 2012, the company raised $40 million.[16]

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.[13][17][18] 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".[17] 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.[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.[20][21]

In October 2013, the company was awarded up to $25 million by DARPA to develop messenger RNA therapeutics.[22]

In November 2013, the company raised $110 million of equity financing.[20]

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.[23] 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.[13][14]

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.[24]

In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.[25]

In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.[26][27]

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).[28][29][30]

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.[31]

In March 2020, the Food and Drug Administration (FDA) approved clinical trials for the Moderna COVID‑19 vaccine candidate, with Moderna receiving investment of $483 million from Operation Warp Speed.[25] Moncef Slaoui, then a member of the board of directors of Moderna, was appointed head scientist for the Operation Warp Speed project.[25]

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.[32]

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.[33] 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.[34]

On December 18, 2020, mRNA-1273 was issued an emergency use authorization (EUA) in the United States.[35][36][37][25] On December 23, 2020, it was authorized for use in Canada.[38][39][40] On January 6, 2021, it was authorized for use in the European Union.[41][42] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.[43]

Moderna partnered with Swiss contract manufacturer Lonza Group to produce the vaccine.[44]

On March 15, 2021, Phase I clinical trials began for mRNA-1283, primarily intended to be used as a COVID-19 vaccine booster.[45]

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.[46][47]

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.[48][49][50]

In July 2021, the company's mRNA vaccine for influenza, code name mRNA-1010, entered Phase I clinical trials.[51]

In August 2021, the company received fast track designation from the Food and Drug Administration for its respiratory syncytial virus vaccine.[52]

In September 2021, the company began work on a combined COVID-19 vaccine booster and influenza vaccine.[53] That same month, it entered an agreement with biomanufacturing company National Resilience to manufacture genetic components for its COVID-19 products at its facility in Mississauga, Ontario.[54]

On April 7, 2022, Moderna and the University of Toronto announced a new partnership to “develop new tools to prevent and treat infectious diseases,” including in the realms of “molecular genetics, biomedical engineering, and biochemistry.[55][56] The collaboration is a joint venture across U of T's Faculties of Applied Science and Engineering and Medicine.

In April 2022, Moderna announced plans to build a $180 million vaccine factory in Montreal, forming a 10-year partnership with the Canadian federal government, province of Quebec, and McGill University to produce 100 million Spikevax doses annually and expand vaccine research capabilities.[57]