Moderna

Moderna, Inc. is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts.

History

Moderna began collaborating with Alexion Pharmaceuticals in January 2014, entering an agreement for ten product options based on Moderna's mRNA platform.1) 2) On January 14, 2014, Moderna announced the creation of Onkaido Therapeutics to focus “exclusively on developing mRNA-based oncology treatments.”3) 4)

On January 8, 2015, Moderna announced the launch of its second spinoff company, Valera, “focused exclusively on the advancement of vaccines and therapeutics for the prevention and treatment of viral, bacterial and parasitic infectious diseases.”[5]

On May 12, 2015, Moderna announced the launch of its third spinoff company, Elpidera, intended to “advance novel messenger RNA therapies” while continuing Moderna's work with Alexion.[6]

On October 22, 2015, Moderna announced the launch of its fourth spinoff company, Caperna, intended to “focus exclusively on the advancement of personalized cancer vaccines.”5) Caperna's work involved collaborations with Merck.6)

On January 12, 2016, Moderna announced that it had entered a funding agreement with the Bill & Melinda Gates Foundation to develop therapeutics against HIV and other diseases. The agreement included an initial $20 million grant, with the potential to increase the amount to $100 million.7) 8)

Organization

Ventures

In addition to its core business, Moderna spun out several venture firms to focus on different applications of their mRNA delivery technology.

Finances

Payments from Moderna

The following is a developing list of individuals and organizations that Moderna has given money to related to the COVID-19 pandemic:

Payments to Individuals

Name Type Amount Description
Soren Gantt Various - Consulting fees prior to or during Gantt's participation in approving COVID-19 vaccines through the National Advisory Committee on Immunization (NACI), and research funding for study using Moderna's COVID-19 vaccine on babies.13) 14)

Payments to Media

Name Type Amount Description
Jimmy Kimmel Live Advertising Unknown Paid skit promoting Moderna's COVID-19 vaccine product.15)

Stock Price

Moderna's stock rose 2000% due to its mRNA quasi-vaccine. It was reported in February 2022 that CEO Bancel sold off $400 million worth of stock.16)


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Company History

Moderna Therapeutics Product Pipeline

2013

Diverse Opportunities, Focused Approach

Messenger RNA Therapeutics™ can be applied to meet patient needs across a broad range of diseases. Initially, we will focus in key disease areas where high unmet medical needs demand safe, efficacious, and innovative therapies: Inherited Genetic Disorders, Hemophilic and Blood Factors, and Oncology. We are also engaging with partners, such as AstraZeneca, in other disease areas to ensure this important innovation reaches patients as quickly as possible.

Moderna has completed preclinical proof-of-concept studies. We have shown that messenger RNA Therapeutics™ can successfully induce in vivo production of dozens of effector proteins through intra-muscular, subcutaneous, and intravenous administration; and have demonstrated safety and efficacy in multiple preclinical models, including non-human primates.

We can generate and test new drug candidates of messenger RNA Therapeutics™ in animals in a matter of weeks, dramatically accelerating the speed of drug development, as well as reducing the cost and risk traditionally associated with discovering and delivering new medicines to patients. This speed, and the flexibility of our enabling technology to address any number of diseases, is giving rise to a robust portfolio of therapeutic candidates.

Watch this space to see how we grow in the coming months.17)

2014

We have focused intensively on supporting the efforts of our partners, AstraZeneca, Alexion and DARPA in the areas of cardiovascular, oncology, rare disease and biodefense.

For our own programs, we will form ventures to focus in key disease areas where high unmet medical needs demand safe, efficacious, and innovative therapies. Onkaido Therapeutics is our first venture company, formed, funded and wholly-owned by Moderna, and focused exclusively on the advancement of oncology products for previously undruggable targets and as a superior alternative to existing drug modalities. Further ventures are being formed and staffed.

Moderna has completed numerous in vivo proof-of-concept studies. We have shown that messenger RNA Therapeutics™ can successfully induce in vivo production of dozens of effector proteins through intra-muscular, subcutaneous, and intravenous administration; and have demonstrated safety and efficacy in multiple preclinical models, including non-human primates.

We can generate and test new drug candidates of messenger RNA Therapeutics™ in animals in a matter of weeks, dramatically accelerating the speed of drug development, as well as reducing the cost and risk traditionally associated with discovering and delivering new medicines to patients. This speed, and the flexibility of our enabling technology to address any number of diseases, is giving rise to a robust portfolio of therapeutic candidates.18)

2016

At Moderna, we are developing a new class of therapeutics composed of messenger RNA (mRNA). Our novel mRNA core expression platform builds on the finding that modified mRNA can train the body’s cells to produce nearly any protein, from native proteins to antibodies and other innovative structures that can have therapeutic effects both within and outside of cells. Across our ecosystem of Moderna ventures and external partners, we are rapidly advancing a deep, diverse pipeline that covers a broad expanse of drug modalities with the potential to address numerous diseases and impact countless lives.19)

2017

In 2017, Moderna further advertised its foray into mRNA research.20)

Meanwhile, Moderna CEO Bancel was said to drive away top talent in a caustic work environment, and mRNA therapy designed to solve Crigler-Najjar wasn't bearing fruit.21)

Pipeline by Therapeutic area22)

Our Drug Design Studio enables rapid design of multiple mRNAs

As our scientists create new mRNA concepts, they can design mRNAs for research and testing, within days, using our proprietary systems. As the Digital Biotech Company™, we utilize the software-like property of mRNA in our proprietary, web-based Drug Design Studio. Our scientists request mRNAs for a specific protein, and the protein target is automatically converted to an initial optimized mRNA sequence. Using our Sequence Designer module, they can tailor entire mRNAs from the 5’-UTR to the coding region to the 3’-UTR based on our ever-improving proprietary learnings. The mRNA sequence is then further optimized using our proprietary bioinformatics algorithms. Our digital ordering then ensures rapid and accurate transmission of sequences to our modular synthesis robotics.

Our proprietary in-house digital application suite contains a Sequence Designer module to tailor an entire mRNA, with ever-improving rule sets that contain our accumulated learning about mRNA design. Drug Design Studio utilizes cloud-based computational capacity to run various algorithms we have developed to design each mRNA sequence. The utility of cloud-based capacity allows us to provide flexible computational capacity on demand, allowing the Research Engine to power parallel intake and design of multiple mRNA sequences.

Scientists can begin by selecting any protein in the human proteome to be further engineered, including antibodies, or they can design novel proteins like traps, fusion proteins, or completely novel scaffolds and sequences. All can be designed to explore previously undruggable pathways.

The Drug Design Studio integrates with Moderna’s automation platforms – directing orders through each phase of mRNA synthesis. Once the order is placed, Moderna’s high-throughput mRNA pre-clinical production facility manages the manufacturing of mRNA constructs and delivers them in just weeks.

We aim to accelerate the pace and success rate of mRNA discovery research efforts across our therapeutic areas and for our strategic collaborators. With the ability to receive high-quality mRNA constructs in a short period of time, scientists are able to quickly run experiments to test a concept. Additionally, scientists can design large parallel experiments with multiple comparison arms using different mRNA constructs. This enables scientists to narrow their field of drugs candidates rapidly, ultimately bringing forth development candidates that can advance into and through the clinical development process.23)

2018

24) Life -cycle to mRNA-1893 Abbreviations: AZ, AstraZeneca; α-GAL, alpha galaxtosidase; CMV, cytomegalovirus; CRC, colorectal cancer; hMPV, human metapneumovirus; IL12, interleukin 12; IL23, interleukin 23; IL36γ, interleukin 36 gamma; MUT, methylmalonyl-CoA mutase; MSCLC, non-small cell lung cancer; PAH, phenylalanine hydroxylase; PCCA/PCCB, propionyl-CoA carboxylase subunit A/B; PCV, personalized cancer vaccine; PIV3, human parainfluenza 3; RSV, respiratory syncytial virus; VEGF-A, vascular endothelial growth factor A; VZV, varicella zoster virus.

Moderna’s Patent Estate

Moderna has pioneered the development of modified messenger RNA (mRNA) medicines since our founding. We are a leader in the space, having advanced 21 programs using modified mRNA technologies into development. As of July 2018, we have announced ten clinical programs for internal and partnered mRNA therapeutics and vaccines.

Along the way, we have amassed a broad and deep patent estate. This includes foundational patents in modified mRNA technologies and delivery technologies that are essential for mRNA therapeutics and vaccines, including their application in specific unmet needs in infectious diseases, cancer (immuno-oncology), and rare and cardiometabolic diseases, among others.

To date, Moderna has been granted over 100 patents in the United States, Europe, Japan and other jurisdictions, protecting fundamental inventions in the mRNA therapeutics space, with several hundred additional pending patent applications covering key advances in the field. We have augmented our internal patent estate with several in-licensed patent estates, including licenses to pioneering discoveries from Harvard University and the University of Pennsylvania.25)

Early Development Engine Components

Learn about the components of our integrated Early Development Engine, including our clinical development manufacturing site in Norwood, MA.26)

Patents

Moderna holds a large number of genomic patents. One of those patents is on a 19 nucleotide sequence (CTCCTCGGCGGGCACGTAG) that happens to be found at the furin cleavage of SARS-CoV-2, fueling speculation that Moderna may have been involved in the engineering of the virus.27)

Products Brought to Market

Just kidding. They never produced a product before inventing the very first functional mRNA vaccine is approximately 53 hours, 13 minutes and 47 seconds.

Moderna's mRNA-1273 Injectable Product

Moderna's groundbreaking Moderna mRNA-1273 coronavirus vaccine was designed in just 2 days. 28)

Production of mRNA-1273

Research and Collaboration

  • Moderna entered into confidentiality agreements with the National Institutes of Health and the NIAID, along with the University of North Carolina, Chappel Hill where Ralph Baric works. The agreement pertains to “the development of vaccines for HIV, influenza, Ebola and MERS and the development of broadly neutralizing monoclonal antibodies for preventative and therapeutic use.”29)
  • 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, biochemistry and beyond.”30)

Foundation Partners

In January 2016, we entered a global health project framework agreement with the Bill & Melinda Gates Foundation to advance mRNA-based development projects for various infectious diseases. The Bill & Melinda Gates Foundation has committed up to $20.0 million in grant funding to support our initial project related to the evaluation of antibody combinations in a preclinical setting as well as the conduct of a first-in-human Phase 1 clinical trial of a potential mRNA medicine to help prevent human immunodeficiency virus, or HIV, infections.

Follow-on projects which could bring total potential funding under the framework agreement up to $100.0 million (including the HIV antibody project) to support the development of additional mRNA-based projects for various infectious diseases can be proposed and approved until the sixth anniversary of the framework agreement, subject to the terms of the framework agreement, including our obligation to grant to the Bill & Melinda Gates Foundation certain non-exclusive licenses.31)

COVID-19 Pandemic

Moderna's stock price soared as it developed and rolled out an mRNA vaccine purported to stop COVID-19.

Stephane Bancel

In February, 2022, Stephane Bancel deleted his Twitter account.32)

HIV Vaccine

Get Ready for It- The Return of AIDS (and a new vaccine) 21st Century Wire News Desk - February 11, 2022

In the past few days the topic of HIV/AIDS has been thrust back into the spotlight. On 27 January, it was announced that Moderna is launching clinical trials for a new HIV vaccine using mRNA technology. A few days later on 3 February, Oxford University researchers published a study in the Journal Science claiming discovery of the “VB variant” of HIV, and describing it as “highly virulent”.

This news about the VB variant’s higher virulence was a point that mainstream news media made sure to repeat and amplify. Here are a selection of headlines covering the story:

New Scientist- ‘VB’ is a new and more infectious variant of HIV – but it is treatable Daily Mail- New HIV super-strain is found in the Netherlands: Highly infectious variant makes people ill twice as quickly Independent- HIV VB ‘Exceptionally’ virulent variant discovered in the Netherlands

While the study found viral loads of those infected with VB could be up to 5.5 times higher, the large number of mutations caused several MSM outlets to declare it a ‘super-mutant’ or ‘super-strain’.

That some of the MSM are calling this variant “new” is problematic, however. The study makes very clear that this variant of HIV has been circulating since at least 1992, that the most recent case was diagnosed in 2014, and that in total only 109 individuals with the strain could be found. The variant is not new; the only new part is the research identifying this variant as distinct from other strains of HIV. But fear sells.

Luckily, this scary ‘new’ variant of HIV has been identified just in time to make Moderna’s HIV vaccine trials seem more relevant. This particular vaccine candidate, known as IAVI G002, was developed in conjunction with Scripps Research and the International AIDS Vaccine Initiative (IAVI), and the trial is being partially funded by the Bill & Melinda Gates Foundation.

America’s Frontline Doctors33) state that “Doctors are calling this phenomena in the repeatedly vaccinated “immune erosion” or “acquired immune deficiency”, accounting for elevated incidence of myocarditis and other post-vaccine illnesses that either affect them more rapidly, resulting in death, or more slowly, resulting in chronic illness.”

This theory rests at least partially on a Lancet34) study conducted late last year, which concluded that the level of protection afforded by COVID vaccination decreases over time, eventually even passing the point where the vaccinated are at greater risk than the unvaccinated.

Incidentally, this is not the first time there has been a connection between COVID and HIV. In December 2020 it was reported that an Australian COVID vaccine candidate was abandoned during trials after some recipients falsely tested positive for HIV. That suggests at least the possibility of a connection between the two things.35)

May 2022 CFO Scandal

Moderna CFO Jorge Gomez exits after one day as old company launches probe May 11, 2022 NY Post By Thomas Barrabi

Moderna’s new financial chief left the COVID-19 vaccine maker after just one day on the job as his old employer revealed it had launched an internal probe of its bookkeeping.

Moderna chief financial officer Jorge Gomez’s brief tenure at the company ended Tuesday — within a day of dental equipment maker Dentsply Sirona’s disclosure of a probe related to “allegations regarding certain financial reporting matters submitted by current and former employees.”

The probe is examining whether the company’s use of incentives to sell products to distribution partners was “appropriately accounted for” in financial reports last fiscal year — and whether certain executives pushed the incentives to receive bonuses.

Gomez had just started his role as Moderna’s CFO on Monday. He will receive 12 months of salary equal to $700,000 but will forfeit his $500,000 signing bonus and any eligibility for relocation reimbursement or new hire equity awards, Moderna said in an 8-K filing.

When his appointment was announced last month, Moderna CEO Stephane Bancel was effusive in his praise of Gomez — stating that the executive’s “passion for sustainability and ESG aligns closely with Moderna’s vision to make corporate responsibility a critical part of who we are and what we do.”

Moderna announced Gomez’s departure in a brief press release on Wednesday, noting that he “has departed the company, effective immediately.”

The biotech giant said retired CFO David Meline would return to the role until Moderna can identify a permanent replacement. “The announcement follows the May 10 public disclosure by Mr. Gomez’s former employer, Dentsply Sirona Inc., of an ongoing internal investigation into certain matters, including financial reporting,” Moderna said, without providing further details on the matter. 36)

Company Linked to CIA Now Making mRNA for Moderna’s Reformulated COVID Booster Shots

Since late last year, messenger RNA for Moderna’s COVID-19 vaccines, including its recently reformulated Omicron booster, has been exclusively manufactured by National Resilience, a little-known company with significant ties to US intelligence. By Whitney Webb

However, unlike the company’s original COVID-19 vaccine, the genetic material, or messenger RNA (mRNA), for this new vaccine, including the newly formulated genetic material meant to provide protection against the Omicron variant, is being manufactured, not by Moderna, but by a relatively new company that has received hardly any media attention, despite its overt links to U.S. intelligence.

Last September, it was quietly announced that a company called National Resilience (often referred to simply as Resilience) would begin manufacturing the mRNA for Moderna COVID-19 vaccine products.

Under the terms of the multi-year agreement, “Resilience will produce mRNA for the Moderna COVID-19 vaccine at its facility in Mississauga, Ontario, for distribution worldwide.” 37)

US Open Sponsor 2022

Reuters - Tennis: Top seed Dimitrov forced to retire against Thiem in Winston-Salem

With less than a week to go before the start of the US Open, the 31-year-old Bulgarian came out sharp, unleashing a torrent of backhanded slices to keep Thiem off balance as he raced through the surprisingly one-sided first set 6-0.

But things took a turn for the worse for world No. 19 Dimitrov at 2-2 in the second and he began to misfire in bunches in an apparent attempt to shorten points. fter a visit from medical staff, he stepped up to the line to serve while trailing 2-4 but decided he was feeling too unwell to continue and shook hands at the net, where he waited for Thiem while hunched over. 38)

1) , 10)
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2)
Reidy, C. (2014, January 13). Alexion, Moderna announce agreement to develop messenger RNA therapeutics. Boston Globe Media Partners. https://web.archive.org/web/20230605072835/https://www.boston.com/news/innovation/2014/01/13/alexion-moderna-announce-agreement-to-develop-messenger-rna-therapeutics/
3)
Favorito, M. (2014, January 14). Moderna Launches Onkaido Therapeutics to Focus on the Development of mRNA TherapeuticsTM in Oncology with $20 Million Capital Commitment. Moderna Therapeutics. http://archive.today/2016.11.20-035524/http://www.modernatx.com/news-events/press-releases/moderna-launches-onkaido-therapeutics-focus-development-mrna-therapeuticstm
4)
Gormley, B. (2014, January 15). Moderna Launches Cancer Drug Co. Onkaido Therapeutics With $20M Investment. Wall Street Journal. http://archive.today/2023.06.05-073743/https://www.wsj.com/amp/articles/DJFVW00020140114ea1eqwhzn
5)
Melone, L. (2015, October 22). Moderna Launches Caperna LLC, Its Fourth Venture, to Develop Personalized Cancer Vaccines. Moderna Therapeutics. https://web.archive.org/web/20161119220026/http://www.modernatx.com/news-events/press-releases/moderna-launches-caperna-llc-its-fourth-venture-develop-personalized-cancer
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Bill & Melinda Gates Foundation — Advancing an mRNA-based antibody combination to help prevent HIV infection. Moderna. Retrieved March 21, 2022, from http://archive.today/2021.08.23-023928/https://www.modernatx.com/ecosystem/strategic-collaborators/foundations-advancing-mrna-science-and-research
8)
Moderna Wins Initial $20M Grant from Gates Foundation. (2016, January 12). GEN - Genetic Engineering and Biotechnology News. http://archive.today/2023.02.03-040340/https://www.genengnews.com/topics/omics/moderna-wins-initial-20m-grant-from-gates-foundation/
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mRNA-based Oncology Treatments. Onkaido Therapeutics. Retrieved October 12, 2016, from https://web.archive.org/web/20161012181337/http://onkaido.com/about/
12)
Valera. (2016). Moderna Therapeutics. https://archive.ph/erYpO
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Montreal clinical trial to vaccinate babies with COVID-19 shot. (2021, December 3). City News Montreal. https://web.archive.org/web/20220417174636/https://montreal.citynews.ca/video/2021/12/03/montreal-clinical-trial-to-vaccinate-babies-with-covid-19-shot/
14)
Lebatteux, D., Soudeyns, H., Boucoiran, I., Gantt, S., & Diallo, A. B. (2022). Machine learning-based approach KEVOLVE efficiently identifies SARS-CoV-2 variant-specific genomic signatures. bioRxiv. Preprint. https://doi.org/10.1101/2022.02.07.479343
15)
Kimmel, J., & Jimmy Kimmel Live (@JimmyKimmelLive). (2021, April 2). Dr. Jimmy answers questions about the COVID-19 vaccines & mRNA science! @Moderna_tx #SponsoredByModerna. [Tweet]. Twitter. https://archive.ph/fyITR
30)
Kalvapalle, R. (2022, April 7). U of T partners with Moderna to advance research in RNA science and technology. University of Toronto News. https://archive.ph/BCZIq
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