Moderna

Moderna, Inc ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts. It focuses on vaccine technologies based on messenger RNA (mRNA). 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. Moderna develops mRNA therapeutic vaccines that are delivered in lipid nanoparticle, using mRNA with pseudouridine nucleosides. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis.
The company's only commercial product is the Moderna COVID-19 vaccine. The company has 24 vaccine candidates, including vaccine candidates for seasonal flu, 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.
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.
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. 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 a company named from the combined terms "modified" and "RNA" that just happens to contain "modern".
In 2011, Noubar 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 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, 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", , only one candidate has passed PhaseI trials, a treatment for myocardial ischemia, labelled AZD8601.
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 $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 humans.
2018–2020.
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, and had raised $3.2billion in equity since 2010.
2020–2021: COVID-19 vaccine.
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. The next day, the FDA approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483million from Operation Warp Speed. Moderna board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed project.
In July 2020, the Moderna COVID-19 vaccine candidate, mRNA-1273, was shown in a PhaseI trial to be immunogenic in a small number of volunteers aged 18–55 years.
As of November 2020, Moderna planned to sell the vaccine for $32-37 per dose.
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.
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 PhaseIII trial, 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. On December 18, 2020, mRNA-1273 was issued an 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 March 15, 2021, Moderna's second COVID-19 vaccine (mRNA-1283) started phase I clinical trials.
Criticism.
Conflict of interest of board member.
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 $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.
CEO.
CEO Stéphane Bancel has been criticized for hampering progress at Moderna because of his ego, his need to assert control and his impatience with setbacks. He has allegedly sent abusive emails and reprimanded and fired employees on the spot after failed experiments. Bancel sought employee retention techniques from the human resources departments of Facebook, Google, and Netflix. Before joining Moderna, Bancel worked in sales and did not have much of a career in the scientific fields. Despite never having worked with RNA before, Bancel "is listed as a co-inventor on more than 100 of Moderna's early patent applications, unusual for a CEO who is not a PhD scientist". He has been described by a former colleague as having a "warrior personality".