Moderna
Moderna, Inc., ( ) 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. As of 2022, the company has 44 treatment and vaccine candidates, of which 21 have entered clinical trials. Targets for 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. 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. In 2007, Rossi set out to build on their findings as a new assistant professor at Harvard Medical School running his own lab. 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. 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. Together they founded "ModeRNA Therapeutics", 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 $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". 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. 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 October 2013, the company was awarded up to $25million by DARPA to develop messenger RNA therapeutics. In November 2013, the company raised $110million of equity financing. 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. 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 	Moderna
26356256	humans. 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. 2018–2019: Initial public offering. In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development. In July 2018, the company opened a  200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work. In December 2018, Moderna became a public company via the largest biotech initial public offering in history, raising $621million (27 million shares at $23 per share). Through year-end 2019, Moderna had accumulated losses of $1.5billion since inception, with a loss of $514million 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 $483million 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. 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. 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. 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. Moderna partnered with Swiss contract manufacturer Lonza  Group to produce as much as 1 billion doses in 2021. On March 15, 2021, Phase I clinical trials began for mRNA-1283, primarily intended to be used as a COVID-19 vaccine booster. 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. 2021-2022: 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. In July 2021, the company's mRNA vaccine for influenza, code name mRNA-1010, entered Phase I clinical trials. In August 2021, the company received fast track designation from the Food and Drug Administration for its respiratory syncytial virus vaccine. In September 2021, the company began work on a combined COVID-19 vaccine booster and influenza vaccine. 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. The collaboration is a joint venture across U of T's Faculties of Applied Science and Engineering and Medicine. Operations and finances. 2021. In 2021, the COVID-19 vaccine, "Spikevax", was approved in 70 countries, with 807 million doses distributed worldwide. Moderna had a global team of 3,000 and 21 commercial subsidiaries operating internationally, including four new Asian locations and six in Europe. Moderna had advance purchase agreements for Spikevax of $19 billion for 2022. Mainly  on sales of Spikevax, Moderna had total 2021 revenue of $18.5 billion and net income of $12.2 billion, compared to $803 million in total revenue for 2020. As of early 2022, Moderna had 44 mRNA vaccine and drug products in research and development (R&D) at a total cost of $2 billion in 2021, an R&D amount expected to double in 2022. Controversies. Vaccine patent dispute. Moderna is involved in a patent dispute with the NIH over its COVID-19 vaccine. According to the NIH, three of its scientists played a major role in developing the vaccine over  four years of collaboration. After first refuting the shared patent application entirely, Moderna postponed the final payment for filing the application, thereby leaving the patent application unfiled, as of December 2021.