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Moderna, Inc.
FormerlyModeRNA Therapeutics
(2010–2018)
Company typePublic
IndustryBiotechnology
FoundedSeptember 2010; 14 years ago (2010-09)
Founders
Headquarters200 Technology Square
Cambridge, Massachusetts, U.S.[3]
Key people
ProductsModerna COVID-19 Vaccine (pending)[6]
RevenueIncrease US$ 232.65 million (2020)[7]
Negative increase −US$ 488.106 million (2020)[7]
Negative increase −US$ 474.579 million (2020)[7]
Total assetsIncrease US$ 4.75 billion (2020)[7]
Total equityIncrease US$ 2.759 billion (2020)[7]
Number of employees
830 (2019)[7]
Websitemodernatx.com

Moderna is an American biotechnology company based in Cambridge, Massachusetts. It focuses on drug discovery, drug development, and vaccine technologies based exclusively on messenger RNA (mRNA).[8][9]

Moderna's technology platform inserts synthetic nucleoside-modified mRNA (modRNA) into human cells. This mRNA then reprograms the cells to prompt immune responses. It is a novel technique, previously abandoned due to the side effects of inserting mRNA into cells.[10][11][12] As of November 2020, the Moderna COVID-19 vaccine candidate, mRNA-1273, had shown preliminary evidence of 94% efficacy in preventing COVID-19 disease in a Phase III trial, with only minor flu-like side effects. This led to its submission for emergency use authorization (EUA) in Europe, the United States, and Canada.[13][14] On December 18, 2020, mRNA-1273 was issued an EUA in the United States.[15]

History

2010–2016

Moderna headquarters in Cambridge, Massachusetts

In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist Derrick Rossi. Rossi had developed a method of modifying mRNA by first transfecting it into human cells, then dedifferentiating it into stem cells which could then be further redifferentiated into desired target cell types.[16][17] Rossi approached fellow Harvard University faculty member Tim Springer, who solicited co-investment from Kenneth Chien, Bob Langer, and venture capital firm Flagship Ventures.[17][18]

In 2011, the CEO of Flagship Ventures (now Flagship Pioneering), Noubar Afeyan, brought in European pharma sales and operations executive Stéphane Bancel as CEO.[17][10] Afeyan personally owned 19.5% of Moderna and was the largest single shareholder, while his fund, Flagship Pioneering, owned 18%.[19]

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.[10][20][21] The agreement included a $240 million upfront payment to Moderna, a payment that 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",[20] and an 8% share in Moderna.[19] As of May 2020, only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled AZD8601.[a][23]

In January 2014, Moderna and Alexion Pharmaceuticals entered a $125 million deal for orphan diseases in need of therapies. Alexion paid Moderna $100 million for 10 product options to develop rare-disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform.[24] By 2016, Bancel told an audience of JPMorgan Chase investors that the work with Alexion would shortly enter human trials. However, by 2017, the program with Alexion had been scrapped as the animal trials showed that Moderna's treatment would never be safe enough for use in humans.[10][12]

Most of the biotech community did not value vaccines. It was very hard to move that stuff forward. Because people said, "Oh, vaccines, nobody's going to pay for that."

Jeff Ellsworth, Former Senior Director of Preclinical Pharmacology and Head of Rare Genetic Diseases, Moderna (2020)[9]

In 2014, after disappointing standalone therapeutic trials,[b] Moderna moved to focus on mRNA vaccines given that, efficacy issues aside, mRNA will always stimulate a level of antibody development in subjects.[9][12] The change in strategy had risk given the materially lower margins of vaccine development (called "loss-leaders" by some Moderna employees),[9] with some senior employees and industry experts questioning the future viability of the company.[9][12] Rossi left the company.[9]

In February 2016, an op-ed in Nature 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.[26] In September 2018, Thrillist published article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[27] 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 more than $5 billion.[10][11] A former Moderna scientist told Stat: "It's a case of the emperor's new clothes. They're running an investment firm, and then hopefully it also develops a drug that's successful".[10]

2018–2020

In 2018, the company rebranded as "Moderna Inc." with the ticker symbol MRNA, and further increased its portfolio of vaccine development.[9] In December 2018, Moderna became the largest biotech initial public offering in history, raising $621 million (27 million shares at $23 per share) on NASDAQ, and implying an overall valuation of $7.5 billion for the entire company.[28][29] The year-end 2019 SEC filings showed that Moderna had accumulated losses of $1.5 billion since inception, with a loss of $514 million in 2019 alone, and had raised $3.2 billion in equity since 2010.[9][19] As of December 2020, Moderna was valued at $60 billion.[30]

In March 2020, in a White House meeting between the Trump administration and pharmaceutical executives, Bancel told the president that Moderna could have a COVID-19 vaccine ready in a few months.[9] The next day, the FDA approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483 million from Operation Warp Speed.[9] Moderna board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed project.[9]

Overview

Moderna develops mRNAs that are delivered in lipid nanoparticle, using mRNA with pseudouridine nucleosides. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis. [31] As of December 2020, no mRNA vaccine had completed Phase III clinical trials or had been licensed for prophylactic use in humans.[32]

The Moderna COVID-19 vaccine candidate, mRNA-1273, was shown in a Phase I trial to be immunogenic in a small number of volunteers aged 18-55 years.[33]

Leadership

Since 2011, Moderna has been led by CEO Stéphane Bancel, a French businessman with a pharmaceutical sales and operations background.[10][9] Bancel has been described as having a secretive approach to Moderna, and as being a tough operator.[10][9] Though never having worked with RNA before, Stat noted that 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".[10] After Noubar Afeyan and Robert Langer, Bancel is the largest individual shareholder in the company.[34]

Stephen Hoge, M.D., is President and a former McKinsey & Company management consultant who joined in 2012; he is the fourth-largest individual shareholder in the company.[34][5]

David Meline is CFO.[5]

Stock sales

On May 18, 2020, when Moderna announced it was making progress with its coronavirus vaccine, company stock rose 30%. That day, CFO Lorence Kim bought stock for $3 million and immediately sold it for $19.8 million. The next day, chief medical officer Tal Zaks bought stock for $1.5 million and immediately sold it for $9.77 million. Both of these executives were using automated insider trading plans known as 10b5-1 plans.[35]

On May 21 and 22, Moderna's leading shareholder, the venture capital firm Flagship Pioneering, made $69.5 million by selling Moderna stock. Flagship is listed as a Moderna "insider" but did not use an automated 10b5-1 plan for these sales.[36]

Board

Noubar Afeyan, CEO of Flagship Pioneering, has been the chairman of Moderna's board of directors since 2011.[37] Afeyan who has a Ph.D. in biochemical engineering[38] holds his interest in Moderna through various Flagship Pioneering vehicles. At the 2018 IPO, documents filed stated that Afeyan owned 19.5% of the company, while Flagship owned 18%, thus giving Afeyan control over 37.5% of the company.[19]

In May 2020, board member Dr. Moncef Slaoui resigned from the company to become Chief Scientist for the Trump administration's "Operation Warp Speed", a group designed to accelerate the development of a vaccine for the coronavirus. 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 coronavirus vaccine trials. Senator Elizabeth Warren called the holding a conflict of interest and stated that Slaoui should have divested his options.[39]

COVID-19 vaccine candidate

Main article: mRNA-1273
See also: COVID-19 vaccine § Clinical trials started in 2020, and RNA vaccine

Design and Phase I-II trials

In January 2020, Moderna announced development of an RNA vaccine, named mRNA-1273, to induce immunity to SARS-CoV-2.[40][41][42] Moderna's technology is a nucleoside-modified messenger RNA (modRNA) compound named mRNA-1273, which induces immunity to SARS-CoV-2 by encoding a prefusion stabilized spike (S) protein naturally present on the surface of SARS-CoV-2 particles. From the announcement, Moderna's shares rose dramatically, and the CEO and other corporate executives began large program sales of their shareholdings.[43]

In March 2020, the Phase I human trial of mRNA-1273 began in partnership with the US National Institute of Allergy and Infectious Diseases.[44] In April, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated up to $483 million for Moderna's vaccine development.[45] Plans for a Phase II dosing and efficacy trial to begin in May were approved by the FDA.[46] Moderna signed a partnership with Swiss vaccine manufacturer Lonza Group,[47] to supply 300 million doses per annum.[48]

On May 25, 2020, Moderna began a Phase IIa clinical trial recruiting 600 adult participants to assess safety and differences in antibody response to two doses of its candidate vaccine, mRNA-1273, a study expected to complete in 2021.[49] In June 2020, Moderna entered a partnership with Catalent in which Catalent will fill and package the vaccine candidate. Catalent will also provide storage and distribution.[50]

On July 9, Moderna announced an in-fill manufacturing deal with Laboratorios Farmacéuticos Rovi, in the event that its vaccine is approved.[51]

On July 14, 2020, Moderna scientists published preliminary results of the Phase I dose escalation clinical trial of mRNA-1273, showing dose-dependent induction of neutralizing antibodies against S1/S2 as early as 15 days post-injection. Mild to moderate adverse reactions, such as fever, fatigue, headache, muscle ache, and pain at the injection site were observed in all dose groups, but were common with increased dosage. [52][53] The vaccine in low doses was deemed safe and effective in order to advance a Phase III clinical trial using two 100-μg doses administered 29 days apart.[52]

In July 2020, Moderna announced in a preliminary report that its Operation Warp Speed candidate had led to production of neutralizing antibodies in healthy adults in Phase I clinical testing.[52][54] "At the 100-microgram dose, the one Moderna is advancing into larger trials, all 15 patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection."[55] The troublesome higher doses were discarded in July from future studies.[55]

Criticisms

In May 2020, after releasing partial and non-peer reviewed results for only 8 of 45 candidates in a preliminary pre-Phase I stage human trial direct to stock markets, the CEO announced on CNBC an immediate $1.25 billion rights issue to raise funds for the company, at a $30 billion valuation.[56] while Stat said, "Vaccine experts say Moderna didn't produce data critical to assessing COVID-19 vaccine".[57]

On July 7, disputes between Moderna and government scientists over the company's unwillingness to share data from the clinical trials were revealed.[58]

Phase III trials

Moderna and the National Institute of Allergy and Infectious Diseases began a Phase III trial in the United States on July 27 with a plan to enroll and assign 30,000 volunteers to two groups — one group receiving two 100-μg doses of mRNA-1273 vaccine and the other receiving a placebo of 0.9% sodium chloride.[59] As of August 7, more than 4,500 volunteers had enrolled.

In September 2020, Moderna published the detailed study plan for the clinical trial.[60] On September 30, CEO Stéphane Bancel said that, if the trial is successful, the vaccine might be available to the public as early as late March or early April 2021.[61] As of October 2020, Moderna had completed the enrollment of 30,000 participants needed for its Phase III trial.[62]

On November 16, 2020, Moderna announced preliminary data from its Phase III clinical trial, indicating 94% efficacy in preventing COVID-19 infection.[63][64] Side effects included flu-like symptoms, such as pain at the injection site, fatigue, muscle pain, and headache.[63] The Moderna results were not final – as the trial is not scheduled to conclude until late-2022[65] – and were not peer-reviewed or published in a medical journal.[63] The US National Institutes of Health announced on November 15, 2020 that overall trial results were positive.[66]

In November 2020, Nature reported that "While it's possible that differences in LNP formulations or mRNA secondary structures could account for the thermostability differences [between Moderna and BioNtech], many experts suspect both vaccine products will ultimately prove to have similar storage requirements and shelf lives under various temperature conditions".[67]

Since September 2020, Moderna has used Roche Diagnostics' Elecsys® Anti-SARS-CoV-2 S test, approved by the US FDA on November 25, 2020. According to an independent supplier of clinical assays in microbiology, "this will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies". The partnership was announced by Roche on December 9, 2020.[68]

After FDA review in December 2020, interim results of the Phase III clinical trial on mRNA-1273 showed it to be safe and effective against COVID-19 infection, resulting in the issuance of an EUA for the United States.[15]

It remains unknown whether the Moderna vaccine candidate is safe or effective in people under age 18, how long it provides immunity, whether it requires a booster shot,[63] or whether it is effective in people of color.[69] The Moderna news followed preliminary results from the Pfizer-BioNTech vaccine candidate, BNT162b2, with Moderna demonstrating similar efficacy, but requiring storage at the temperature of a standard medical refrigerator of 2–8 °C (36–46 °F) for up to 30 days or −20 °C (−4 °F) for up to 4 months, whereas the Pfizer candidate requires ultracold freezer storage at −70 °C (−94 °F).[63]

Purchase commitments

On August 11, 2020, the US government signed an agreement to buy 100 million doses of Moderna's anticipated vaccine,[70] which the Financial Times said Moderna planned to price its vaccine between $50–60 per course.[71] On November 2020, Moderna has stated that it will charge governments who purchase its vaccine between $25 and $37 per dose while the EU is seeking a price of under $25 per dose for the 160 million doses it plans to purchase from Moderna.[72][73]

In late 2020, Moderna also obtained purchase agreements for mRNA-1273 with the European Union for 160 million doses and with Canada for up to 56 million doses.[74][75] The US government said, they agreed to purchase first phase 5.9 million doses and second phase 200 million doses.[76]

Emergency use authorization

As of December 2020, mRNA-1273 was under evaluation for emergency use authorization (EUA) by multiple countries which would enable rapid rollout of the vaccine in the United Kingdom, the European Union, Canada, and the United States.[9][13][14][77]

On December 18, 2020, mRNA-1273 was approved by the United States FDA under an emergency use authorization.[15][78] This is the first product from Moderna that has been approved by the FDA.[79]

Patent litigation

The PEGylated lipid nanoparticle (LNP) drug delivery system of mRNA-1273 has been the subject of ongoing patent litigation with Arbutus Biopharma, from whom Moderna had previously licensed LNP technology.[80][81] On September 2020, Nature Biotechnology reported that Moderna had lost a key challenge in the ongoing case.[82]

See also

Notes

  1. ^ 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".[22]
  2. ^ Competitor mRNA biotech CureVac had a more spectacular experience in 2017 with the Phase II failure of its prostate cancer therapy, CV9104, which led CEO Ingmar Hoerr to say that "CureVac no longer sees mRNA as a stand-alone therapy", and "What we've learned here is that mRNA is not enough on its own ..".[25]

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