Moderna Therapeutics

Moderna Therapeutics
Industry Biotechnology research and development
Founded 2010 or 2011
Headquarters Cambridge, Massachusetts, U.S.
Key people
 Stéphane Bancel (CEO).[1]
Number of employees
 414
Website www.modernatx.com

Moderna Therapeutics is a biotechnology company that is focused on drug discovery and drug development based on messenger RNA (mRNA).[2]

History

Moderna was founded in 2010 and the name was originally written "ModeRNA".[3] It was based on basic science work by Derrick Rossi at Harvard, whose lab developed a method for modifying mRNA, transfecting into human cells, and dedifferentiating them into stem cells, and then causing them to differentiate into desired cell types.[4] Rossi approached fellow Harvard faculty member Tim Springer who had started a company before, about starting a company and Kenneth R. Chien; they brought in Bob Langer and then all of them met with Noubar Afeyan, the CEO of Flagship Ventures.[4][5] After some further validating experiments, the company was founded.[4] Stéphane Bancel, left his job as CEO of bioMérieux to become CEO in 2011.[4] It operated in stealth mode until December 2012, with a vague website and all employees working under strict confidentiality agreements;[5][6] People thought Moderna was a stem cell company until it emerged from stealth mode in 2012, by which time it had raised $40 million from Flagship Ventures' VentureLabs unit and other private investors.[2][4]

In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop and commercialize mRNA therapeutics for the treatment of serious cardiovascular, metabolic and renal diseases as well as selected targets in oncology.[7][8] The agreement included a $240 million upfront payment to Moderna, a payment that is "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."[7]

In October 2013, the Defense Advanced Research Projects Agency (DARPA) awarded Moderna a grant worth up to $24.6 million to research and develop its mRNA drug technology to fight infectious diseases and biological weapons.[9][10]

In November 2013, Moderna secured an additional $110M in financing.[11] In January 2014, Moderna and Alexion Pharmaceuticals entered a $125 million deal for orphan diseases. Alexion paid Moderna $100 million exchange for 10 product options to develop rare-disease drugs using Moderna’s mRNA Therapeutics platform, and also made another $25 million preferred equity investment in Moderna.[12]

In October 2014, Moderna announced a research and clinical partnership with Karolinska Institutet and Karolinska University Hospital, and established Moderna Therapeutics Sweden in Stockholm as its first expansion outside the U.S.[13]

At the beginning of January 2015, Moderna announced that it had raised $450 million in new funding and at this point had raised $950 million.[14]

On January 8, 2015, Moderna launched Valera, a venture focused exclusively on the advancement of vaccines and therapeutics for the prevention and treatment of viral, bacterial and parasitic infectious diseases.[15]

Also in January 2015, Moderna announced a license and collaboration agreement with Merck for the discovery and development of vaccines against viral diseases. Merck made an upfront cash payment to Moderna of $50 million to commercialize five product candidates, as well as a $50 million equity investment in Moderna.[16]

In May 2015, Moderna launched Elpidera, a venture focused exclusively on developing messenger RNA (mRNA) based medicines for the treatment of rare diseases.[17]

On October 22, 2015, Moderna launched its fourth venture, Caperna, focused on personalized cancer vaccines.[18]

In January 2016, Moderna announced the start of a Phase 1 clinical study in Europe for mRNA 1440 and filed an IND with the U.S. FDA for mRNA 1851. mRNA 1440 and mRNA 1851 are infectious disease vaccines.[19]

In January 2016, Moderna and AstraZeneca announced a new collaboration to develop two mRNA immuno-oncology programs. Moderna will fund and lead discovery and preclinical development. AstraZeneca will lead early clinical development. The companies will share late-stage development costs and co-commercialize products in US with 50:50 profit sharing.[20]

In January 2016, Moderna announced a new agreement with Merck to license a vaccine program for an undisclosed virus – mRNA 1566 and a group of related new vaccine candidates.[21]

In June 2016, Moderna entered into a new collaboration with Merck to develop mRNA-based personalized cancer vaccines to treat multiple types of cancer. Moderna received a $200 million upfront payment to lead R&D efforts through proof-of-concept and to build out of a manufacturing facility.[22]

In July 2016, Moderna announced a collaboration with Vertex to discover and develop mRNA therapeutics for cystic fibrosis. Moderna received a $40M upfront payment including a $20M convertible note investment and may receive $275M in milestone payments.[23]

In July 2016, Moderna and AstraZeneca announced the filing of a clinical trial application for investigational cardiometabolic mRNA drug AZD8601, which encodes for vascular endothelial growth factor A (VEGF-A).[24]

In September 2016, Moderna announced a funding award from BARDA to develop a Zika mRNA vaccine. The award includes $8 million to support a Phase 1 study, and options for additional funding up to $117 million to support Phase 2 and Phase 3 studies, and large-scale manufacturing.[25]

In September 2016, Moderna announced a $474 million equity financing from existing institutional investors and pharma partners, and new institutional investors from the U.S., Europe and Asia.[26]

In September 2016, Moderna announced that it was going to start building a 200,000 sq ft GMP mRNA manufacturing facility in Norwood, Mass.[27][28]

By 2017 the company was said to have a $5B valuation, which many analysts found to be an overvaluation.[29][30]

Platform

In 2017 Science published an article describing Moderna's platform, which was the result of several months of discussions with Moderna employees. Moderna had made the strategic decision to disclose some of its approach in an effort to break the hype cycle into which it was getting locked.[31] The Science piece disclosed that Moderna was delivering some of its mRNA therapeutic candidates in liposomes, that they were using modified uridine nucleosides based on work done by Katalin Karikó on avoiding immune responses to mRNA drugs, that the company was using mRNAs with modified sequences to improve folding and translation efficiency, and that their mRNA drug candidates were modified on each end, outside the coding region, to target them to specific cell types.[31]

References

  1. ↑ Kyle Alspach (May 22, 2013). "Moderna CEO Bancel joins Flagship Ventures as senior partner". Boston Business Journal. Retrieved Dec 11, 2013.
  2. 1 2 Catherine Shaffer (December 6, 2013). "Moderna Makes Entrance with $40M Round for mRNA Work". BioWorld. Retrieved Dec 11, 2013.
  3. ↑ Kutz, Erin (4 October 2010). "ModeRNA, Stealth Startup Backed By Flagship, Unveils New Way to Make Stem Cells". Xconomy.
  4. 1 2 3 4 5 Gregory Huang (December 6, 2012). "Moderna, $40M in Tow, Hopes to Reinvent Biotech with "Make Your Own Drug"". Xconomy.
  5. 1 2 Catherine Elton (March 2013). "The NEXT Next Big Thing". Boston Magazine. Retrieved Dec 11, 2013.
  6. ↑ Michael Farrell (December 6, 2012). "New Cambridge biotech comes out of stealth mode". Boston Globe. Retrieved Dec 11, 2013.
  7. 1 2 Andrew Pollack (March 21, 2013). "AstraZeneca Makes a Bet on an Untested Technique". New York Times. Retrieved Dec 11, 2013.
  8. ↑ Robert Weisman (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Retrieved Dec 11, 2013.
  9. ↑ Emily Mullin (October 2, 2013). "Moderna lands $25M grant to develop its RNA platform against infectious diseases, bioterror". Fierce Biotech. Retrieved Dec 11, 2013.
  10. ↑ Luke Timmerman (October 2, 2013). "Moderna Snags $25M DARPA Grant to Fight Pandemics With mRNA Drugs". Xconomy. Retrieved Dec 11, 2013.
  11. ↑ https://blogs.wsj.com/venturecapital/2013/11/20/the-daily-startup-moderna-to-advance-messenger-rna-therapies-privately-despite-ipo-market/
  12. ↑ Reidy, Chris. "Alexion, Moderna announce agreement to develop messenger RNA therapeutics . Boston Globe. January 13, 2014.
  13. ↑ Press release. "Moderna to Collaborate with Karolinska Institutet and Karolinska University Hospital on Discovery of New Messenger RNA Therapeutics. October 16, 2014.
  14. ↑ Press release. "Moderna Closes $450 Million Financing to Support Growth of Messenger RNA Therapeutics Platform across Diverse Therapeutic Areas". January 5, 2015.
  15. ↑ Press release. "Moderna Launches New Venture Valera LLC for Infectious Diseases". January 8, 2015.
  16. ↑ Press release. "Moderna Announces License and Collaboration Agreement with Merck to Develop Messenger RNA-based Antiviral Vaccines and Passive Immunity Therapies". January 13, 2015.
  17. ↑ Press release. "Moderna Launches Third Venture Company Elpidera for Rare Diseases". May 12, 2015.
  18. ↑ Ben Fidler (October 22, 2015). "With New Startup, Caperna, Moderna Gets in on Cancer Vaccine Buzz". Xconomy. Retrieved January 4, 2016.
  19. ↑ Mark Terry (January 12, 2016). "Booming Moderna Eyes Six Human Trials in 2016, Inks Deals with AstraZeneca PLC (AZN), Merck & Co. (MRK) and Signed Huge Lease in Cambridge for R&D Growth". Biospace. Retrieved January 12, 2016.
  20. ↑ Sten Stovall (January 11, 2016). "AstraZeneca Ups Betting Ante On Moderna's Messenger RNA Technology". Scrip. Retrieved January 11, 2016.
  21. ↑ Mark Terry (January 12, 2016). "Booming Moderna Eyes Six Human Trials in 2016, Inks Deals with AstraZeneca PLC (AZN), Merck & Co. (MRK) and Signed Huge Lease in Cambridge for R&D Growth". Biospace. Retrieved January 12, 2016.
  22. ↑ Stacy Lawrence (June 29, 2016). "Merck, Moderna tie up in $200M deal to develop mRNA-based 'personalized' cancer vaccines". FierceBiotech. Retrieved June 29, 2016.
  23. ↑ John Carroll (July 6, 2016). "Trendy Moderna's single-asset CF pact with Vertex marks a new phase of dealmaking". Endpoints. Retrieved July 6, 2016.
  24. ↑ Ben Adams (July 26, 2016). "Cash-rich Moderna to begin first AstraZeneca trial under collab deal". FierceBiotech. Retrieved July 26, 2016.
  25. ↑ GEN (September 7, 2016). "Moderna Wins Up to $125M from BARDA toward Zika mRNA Vaccine". Genetic Engineering & Biotechnology News. Retrieved September 7, 2016.
  26. ↑ GEN (September 7, 2016). "Moderna Wins Up to $125M from BARDA toward Zika mRNA Vaccine". Genetic Engineering & Biotechnology News. Retrieved September 7, 2016.
  27. ↑ Eric Palmer (September 21, 2016). "Moderna lays out ambitious $110M facility for clinical supplies". FierceBiotech. Retrieved September 21, 2016.
  28. ↑ John Carroll (September 21, 2016). "Biotech unicorn Moderna gambles $110M on a groundbreaking mRNA manufacturing facility, blueprints plant #2". Endpoints. Retrieved September 21, 2016.
  29. ↑ Crow, David (7 September 2017). "Moderna pledge sets investor pulses racing; Biotech group promises to rewrite rules of drug development - though sceptics say $5bn valuation is undeserved". Financial Times.
  30. ↑ Adams, Ben (September 14, 2017). "Moderna changes up R&D model, posts cancer, CV trial updates". FierceBiotech.
  31. 1 2 Servick, Kelly (1 February 2017). "This mysterious $2 billion biotech is revealing the secrets behind its new drugs and vaccines". Science. doi:10.1126/science.aal0686.
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