¶ Moderna
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Moderna is an American biotechnology company based in Cambridge, Massachusetts.
¶ History
In April 2010, Boston Children's Hospital researcher Derrick Rossi and Luigi Warren filed a patent describing “a simple, nonintegrating strategy for reprogramming cell fate based on administration of synthetic mRNA modified to overcome innate antiviral responses.”[1]
The patent and followup paper explictly describe "methods, compositions, and kits comprising synthetic, modified RNAs" which "can be used either to express a desired protein in a cell or tissue, or to change the differentiated phenotype of a cell to that of another, desired cell type."[2]
¶ Founding
Moderna was founded in September 2010 by Derrick Rossi, Timothy Springer, Kenneth Chien, Robert Langer and Noubar Afeyan.[3][4][5]
Moderna began collaborating with Alexion Pharmaceuticals in January 2014, entering an agreement for ten product options based on Moderna's mRNA platform.[6][7] On January 14, 2014, Moderna announced the creation of Onkaido Therapeutics to focus "exclusively on developing mRNA-based oncology treatments."[8][9]
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."[10]
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.[11]
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."[12] Caperna's work involved collaborations with Merck.[13]
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.[14][15]
On June 29, 2016, Moderna and Merck announced they were collaborating on the development of mRNA-based cancer vaccines, including work with Merck's Keytruda.[16]
Moderna sought and received four sublicenses from Acuitas Therapeutics for the use of their patented lipid nanoparticle technology in 2016, whose patents were legally held by Arbutus Biopharma.[17] This led to legal action from Arbutus, striking the previous contract between the two companies and preventing Acuitas from issuing any further licenses.[18]
¶ Zika
On February 17, 2017, a study was published in Cell describing an mRNA vaccine candidate against Zika virus infection developed by Moderna and Valera.[19]
On February 21, 2018, Moderna filed a lawsuit against Arbutus Biopharma challenging one of its lipid nanoparticle patents, titled "Non-liposomal systems for nucleic acid delivery." The company filed a second challenge on March 5, 2018, against Arbutus's patent titled "Lipid formulations for nucleic acid delivery."[20] Meanwhile, a court decision granted Arbutus full ownership over the licenses in question, which the company described as the consolidation of "its LNP intellectual property estate."[21] Moderna was, however, cleared to continue using the LNP tech granted under the existing four sub-licenses within Canada.[22][20:1] On September 12, 2018, Moderna's challenges were instituted, allowing them to proceed.[20:2]
¶ COVID-19
On March 10, 2023, U.S. District Judge Mitchell Goldberg rejected a bid by Moderna to dismiss some of the patent infringement claims brought against the company by Arbutus Biopharma and its partner, Genevant Sciences.[23][24]
New York law firm Levi & Korsinsky filed a class action lawsuit against Moderna, alleging the company misled shareholders over the efficacy of its mRNA-based vaccine against RSV, mRNA-1345.[25]
¶ External links
Rossi, D., & Warren, L. (2012, February 23). Sustained polypeptide expression from synthetic, modified RNAs and uses thereof. United States Patent and Trademark Office. https://web.archive.org/web/20230207044248/https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/20120046346 ↩︎
Warren, L., Manos, P. D., Ahfeldt, T., Loh, Y.-H., Li, H., Lau, F., Ebina, W., Mandal, P. K., Smith, Z. D., Meissner, A., Daley, G. Q., Brack, A. S., Collins, J. J., Cowan, C., Schlaeger, T. M., & Rossi, D. J. (2010). Highly Efficient Reprogramming to Pluripotency and Directed Differentiation of Human Cells with Synthetic Modified mRNA. Cell Stem Cell, 7(5), 618–630. https://doi.org/10.1016/j.stem.2010.08.012 ↩︎
Elton, C. (2013, February 26). Does Moderna Therapeutics Have the Next Big Thing in Medicine? Boston Magazine. https://web.archive.org/web/20230606065355/https://www.bostonmagazine.com/health/2013/02/26/moderna-therapeutics-new-medical-technology/ ↩︎
Walrath, R. (2022, March 16). How Moderna helped RNA drugs come of age. BizJournals; Boston Business Journal. http://archive.today/2022.03.16-200517/https://www.bizjournals.com/boston/news/2022/03/16/how-moderna-helped-rna-drugs-come-of-age.html ↩︎
Garde, D. (2020, November 10). The story of mRNA: How a once-dismissed idea became a leading technology in the COVID vaccine race. STAT News. http://archive.today/2021.09.14-034008/https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ ↩︎
Elpidera. Moderna Therapeutics. Retrieved October 12, 2016, from http://archive.today/2016.10.12-231723/http://www.modernatx.com/our-business-model/ventures/elpidera ↩︎
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/ ↩︎
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 ↩︎
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 ↩︎
Favorito, M. (2015, January 8). Moderna Launches New Venture Valera LLC for Infectious Diseases. Moderna Therapeutics. https://web.archive.org/web/20161119214315/http://www.modernatx.com/news-events/press-releases/moderna-launches-new-venture-valera-llc-infectious-diseases ↩︎
Moderna Launches Third Venture Company Elpidera for Rare Diseases. (2015, May 12). Moderna Therapeutics. https://web.archive.org/web/20161012234942/http://www.modernatx.com/news-events/press-releases/moderna-launches-third-venture-company-elpidera-rare-diseases ↩︎
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 ↩︎
Caperna. Moderna Therapeutics. Retrieved March 25, 2017, from https://web.archive.org/web/20170325011428/https://www.modernatx.com/ecosystem/ventures/caperna ↩︎
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 ↩︎
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/ ↩︎
Eisele, P., & Ronaldo, C. (2016, June 29). Merck and Moderna Announce Strategic Collaboration to Advance Novel mRNA-Based Personalized Cancer Vaccines with KEYTRUDA® (pembrolizumab) for the Treatment of Multiple Types of Cancer. Moderna. https://web.archive.org/web/20170405190328/https://www.modernatx.com/newsroom/press-releases/merck-and-moderna-announce-strategic-collaboration-advance-novel-mrna-based ↩︎
Vardi, N. (2017, May 16). Moderna can’t escape my intellectual property, says Arbutus CEO. Forbes. http://archive.today/2022.03.22-180143/https://www.forbes.com/sites/nathanvardi/2017/05/16/moderna-cant-escape-my-intellectual-property-says-arbutus-ceo/?sh=5b6aeb01633a ↩︎
Cutler, A., Tolmie, T., & Schull, D. (2017, April 13). Arbutus injunction survives attempted appeal by Acuitas. U.S. Securities and Exchange Commission. http://archive.today/2022.03.22-180943/https://www.sec.gov/Archives/edgar/data/1447028/000117184317002101/exh_991.htm ↩︎
Richner, J. M., Himansu, S., Dowd, K. A., Butler, S. L., Salazar, V., Fox, J. M., Julander, J. G., Tang, W. W., Shresta, S., Pierson, T. C., Ciaramella, G., & Diamond, M. S. (2017). Modified mRNA Vaccines Protect against Zika Virus Infection. Cell, 168(6), 1114-1125.e10. https://doi.org/10.1016/j.cell.2017.02.017 ↩︎
Silbersher, Z. (2018, December 17). Does Moderna Therapeutics’ pipeline depend upon its patent dispute with Arbutus Biopharma over mRNA delivery? Markman Advisors. http://archive.today/2022.03.22-180516/https://www.markmanadvisors.com/blog/2018/12/17/does-moderna-therapeutics-pipeline-depend-upon-its-patent-dispute-with-arbutus-biopharma-over-mrna-delivery ↩︎ ↩︎ ↩︎
Tolmie, T., & Schull, D. (2018, February 22). Arbutus settles litigation, terminating Acuitas’ rights to LNP technology. Arbutus Biopharma. http://archive.today/2022.03.22-182650/https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-settles-litigation-terminating-acuitas-rights-lnp-0 ↩︎
Stendahl, M. (2018, February 22). Settlement clears Moderna to use Canadian firm’s drug delivery tech. American City Business Journals. http://archive.today/2021.08.25-231443/https://www.bizjournals.com/boston/news/2018/02/22/settlement-clears-moderna-to-use-canadian-firm-s.html ↩︎
Goldberg, M. (2023). Case 1:22-cv-00252-MSG Document 64. Document Cloud; United States District Court for the District of Delaware. https://web.archive.org/web/20230316161451/https://s3.documentcloud.org/documents/23706145/moderna-covid-19-opinion.pdf ↩︎
Stieber, Z. (2023, March 13). Judge Rejects Request From Moderna, Moving Key COVID-19 Vaccine Case to Discovery. The Epoch Times. http://archive.today/2023.03.13-173504/https://www.theepochtimes.com/judge-rejects-request-from-moderna-moving-key-covid-19-vaccine-case-to-discovery_5119082.html ↩︎
Levi & Korsinsky, LLP. (2024, August 27). Levi & Korsinsky Reminds Moderna, Inc. Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of October 8, 2024 - MRNA. Yahoo! Finance; PR Newswire. https://web.archive.org/web/20240829213109/https://finance.yahoo.com/news/levi-korsinsky-reminds-moderna-inc-094500951.html ↩︎