Moderna

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Moderna, Inc.
Formerly
ModeRNA Therapeutics
(2010–2018)
Public
Traded as
IndustryBiotechnology
FoundedSeptember 2010; 10 years ago (2010-09)
Founders
Headquarters200 Technology Square
Cambridge, Massachusetts 02139
U.S.[1]
Key people
Productsnone
RevenueIncrease $60.2 Million(2019)[4]
Number of employees
820 (Dec 2019)[1]
Websitemodernatx.com

Moderna is an American biotechnology company based in Cambridge, Massachusetts that focus on drug discovery, drug development, and vaccine technologies based exclusively on messenger RNA (mRNA).[5][6]

Synopsis[edit]

The Moderna technology platform is to insert synthetic mRNA into living cells that would reprogram the cells to develop immune responses, rather than being created externally and injected as with conventional medicines. It is a novel technique abandoned by several large pharmaceutical and biotechnology companies that were unable to overcome the side effects of inserting RNA into cells.[7][8][9] As of May 2020, no mRNA drug has been approved for human use.[10][11]

Moderna has conducted mostly unsuccessful trials in traditional high-margin chronic therapeutic areas with AstraZeneca, and in orphan diseases with Alexion Pharmaceuticals. In 2014, Moderna moved to focus on lower-margin vaccines, given that an mRNA vaccineefficacy issues aside – will always stimulate a level of antibody development in subjects.[6][9] The strategic change led industry experts, and Moderna employees, to question the financial viability of the company.[6][9] In the opinion of some former Moderna employees, the safe dose was too weak and "repeat injections of a dose strong enough to be effective had troubling effects on the liver in animal studies."[9]

In December 2018, Moderna became the largest biotech initial public offering (IPO) in history, raising US$600 million for 8% of its shares, implying an overall valuation of $7.5 billion, and with cumulative losses of $1.5 billion and equity raised of $3.2 billion, since inception.[6][12] As of May 2020, Moderna was valued at $30 billion, but none of its mRNA molecules had reached large clinical trials, and several had failed due to side-effects.[6][13]

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 1 clinical testing.[14][15] "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."[16] The troublesome higher doses were discarded in July from future studies.[16]

History[edit]

2010–2016[edit]

In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist Derrick Rossi, who developed a method for modifying mRNA, transfecting it into human cells, then dedifferentiating it into stem cells that could then be further redifferentiated into desired target cell types.[17][18] Rossi approached fellow Harvard University faculty member Tim Springer, who called on Kenneth Chien, Bob Langer, and venture capital firm Flagship Ventures, to co-invest.[18][19]

In 2011, the CEO of Flagship Ventures (now Flagship Pioneering), Noubar Afeyan, brought in European pharma sales and operations executive Stéphane Bancel as CEO.[18][7] Afeyan personally owned 19.5% of Moderna and was the largest single shareholder, while his fund, Flagship Pioneering, owned 18%.[20]

In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop, and commercialize mRNA for treatments in the thereputic areas of cardiovascular, metabolic and renal diseases, and selected targets for cancer.[7][21][22] 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",[21] and an 8% share in Moderna.[20] As of May 2020, only one candidate has passed Phase 1 trials, a treatment for myocardial ischemia, labelled AZD8601.[a][24]

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 [25] 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.[7][9]

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)[6]

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.[6][9] The change in strategy had risk given the materially lower margins of vaccine development (called "loss-leaders" by some Moderna employees),[6] with some senior employees and industry experts questioning the future viability of the company.[6][9] Rossi left the company.[6]

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.[27] In September 2018, Thrillist published article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[28] 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.[7][8] 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".[7]

2018–2020[edit]

In 2018 the company rebranded as "Moderna Inc." with the ticker symbol MRNA, and further increased its portfolio of vaccine development.[6] In December 2018, Moderna became the largest biotech initial public offering in history, raising $621 million (27 million shares at $23 per share) on the NASDAQ, and implying an overall valuation of $7.5 billion for the entire company.[12][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.[6][20]

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.[6] 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.[6] Moderna board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed project.[6]

Leadership[edit]

Executive[edit]

Since 2011, Moderna has been led by CEO Stéphane Bancel, a French businessman who has a pharmaceutical sales and operations background.[7][6] Bancel has been described as having a secretive approach to Moderna, and of being a tough operator.[7][6] 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".[7] After Noubar Afeyan and Robert Langer, Bancel is the largest individual shareholder in the company.[30]

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.[30][3]

David Meline is CFO.[3]

Stock sales[edit]

On 18 May 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.[31]

On 21 and 22 May, 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.[32]

Board[edit]

Since 2011, the Chairman of Moderna has been the CEO of Flagship Pioneering, businessman Noubar Afeyan.[33] Afeyan who has a Ph.D. in biochemical engineering[34] holds his interest in Moderna through various Flagship Pioneering vehicles, however, 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.[20]

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 that Slaoui should have divested his options.[35]

Platform[edit]

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. [36] As of August 2020, no RNA (or RNA vaccine) has been licensed for prophylactic use in humans,[10] however mRNA-1273 at low doses has been shown in the preliminary report on a Phase I trial to be immunogenic in a small number of volunteers aged 18-55 years.[37] More than one in five "participants in the 250-μg dose group reported one or more severe adverse events," and mRNA-1273 induced transient urticaria in both legs to one patient who was given a very low dose.[37]

COVID-19 vaccine[edit]

In January 2020, Moderna announced development of a vaccine (named mRNA-1273) to induce immunity to SARS-CoV-2, in competition with other biotechnology companies, such as Gilead Sciences, Vaxart, Inovio Pharmaceuticals, and Novavax.[38][39][40] Moderna's technology is a messenger RNA (mRNA) 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.[41]

In March 2020, the Phase I human study of the vaccine candidate began in partnership with the US National Institute of Allergy and Infectious Diseases.[42] In April, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated up to $483 million for Moderna's vaccine development.[43] Plans for a Phase II dosing and efficacy trial to begin in May were approved by the FDA.[44] In preparation for future manufacturing, should the vaccine be approved, Moderna signed a partnership with Swiss vaccine producer, Lonza Group.[45] It is intended to supply 300 million doses annually from Lonza Visp for ROW[46].

In May 2020, after releasing partial and non-peer reviewed results for only 8 of 45 candidates in a preliminary pre-Phase 1 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.[47] Former FDA commissioner Scott Gottlieb tempered the CNBC audience by saying that there would be a "long road ahead for Moderna".[48] The Wall Street Journal followed up with "Be Careful Handling White-Hot Moderna Stock",[49] while Stat said, "Vaccine experts say Moderna didn't produce data critical to assessing Covid-19 vaccine".[50][51] William A. Haseltine in a Washington Post opinion piece called it: "publication by press release".[52]

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.[53] On July 7, Reuters reported fights between Moderna and government scientists over the company's unwillingness to share data from the clinical trials or to follow all the steps requested by the government.[13] On July 9, Moderna announced an in-fill manufacturing deal with Laboratorios Farmacéuticos Rovi, in the event that its vaccine is approved.[54]

On 14 July 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. [14][55] 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.[14] Moderna and the National Institute of Allergy and Infectious Diseases began a Phase III trial in the United States on 27 July 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 0.9% Sodium Chloride.[56] As of 7 August, over 4,500 volunteers had enrolled. According to the Financial Times, Moderna planned to price its vaccine between $50-60 per course.[57]

On 11 August 2020, President Trump announced that the United States, as part of Operation Warp Speed, had signed an agreement to buy 100 million doses of Moderna's anticipated vaccine.[58]

In September 2020, Moderna published the detailed study plan for the clinical trial.[59] On 30 September, 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.[60] As of October 2020, Moderna had completed the enrollment of 30,000 participants needed for its Phase 3 trial.[61]

See also[edit]

Notes[edit]

  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".[23]
  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 ..".[26]

References[edit]

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  3. ^ a b c d "Executive Committee & Leadership". Retrieved 13 August 2020.
  4. ^ https://investors.modernatx.com/news-releases/news-release-details/moderna-reports-2019-fourth-quarter-and-full-year-financial
  5. ^ Catherine Shaffer (December 6, 2013). "Moderna Makes Entrance with $40M Round for mRNA Work". BioWorld. Retrieved Dec 11, 2013.
  6. ^ a b c d e f g h i j k l m n o p q Kuznia, Robert; Polglase, Katie; Mezzofiore, Gianluca (1 May 2020). "In quest for vaccine, US makes 'big bet' on company with unproven technology". CNN Investigates. Retrieved 1 May 2020.
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  10. ^ a b Cross, Ryan (3 April 2020). "Will the coronavirus help mRNA and DNA vaccines prove their worth?". Chemical & Engineering News. 98 (14). Retrieved 19 May 2020.
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  12. ^ a b Mukherjee, Sy (8 December 2018). "Moderna Had the Biggest Biotech IPO Ever. Here's What That Says About the Industry's Future". Fortune. Retrieved 18 May 2020.
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  37. ^ a b Jackson, Lisa A.; Anderson, Evan J.; Rouphael, Nadine G.; Roberts, Paul C.; Makhene, Mamodikoe; Coler, Rhea N.; McCullough, Michele P.; Chappell, James D.; Denison, Mark R.; Stevens, Laura J.; Pruijssers, Andrea J. (2020-07-14). "An mRNA Vaccine against SARS-CoV-2 — Preliminary Report". New England Journal of Medicine. 0. doi:10.1056/NEJMoa2022483. ISSN 0028-4793. PMC 7377258. PMID 32663912. 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. All side effects were considered mild or moderate. A higher, 250-microgram dose led to more serious reactions and has been set aside. Although no side effects were severe — meaning that they required hospitalization — they were unpleasant, as was made clear when one volunteer in the study, Ian Haydon, went public with his experience taking the 250-microgram dose.
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  46. ^ Swiss factory rushes to prepare for Moderna Covid-19 vaccine
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External links[edit]