Moderna Therapeutics

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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 researches and develops protein therapies based on novel messenger RNA (mRNA) technology.[2] The company’s technology uses mRNA made of nucleotide analogs to trigger the body’s natural processes to produce proteins inside the human cell.[3] This approach has the potential to produce therapeutic proteins in vivo to treat a wide range of diseases, including those that cannot be effectively treated with existing methods to develop and manufacture drugs.[4]

Moderna’s pipeline of mRNA product candidates covers a broad expanse of drug modalities, including vaccines (both for infectious diseases and personalized cancer vaccines), intracellular/transmembrane proteins, intratumoral expression, and secreted antibodies and proteins.[5] Each modality represents a distinct approach to using the mRNA platform to encode proteins that achieve a therapeutic benefit, enabling the company to develop numerous drug candidates across a wide array of therapeutic areas.[6]

Moderna is led by Stéphane Bancel, CEO and Director of the Board; Stephen Hoge, M.D., President; Marcello Damiani, Chief Digital Officer; Annie Seibold Drapeau, Chief Human Resources Officer, Steven W. Harbin, SVP, Manufacturing and Operations; Saqib Islam, Chief Business Officer; Jim R. Kasinger, J.D., General Counsel; Lorence Kim, M.D., CFO, and Tal Zaks, M.D., Ph.D., CMO.[7]

Founding[edit]

The company was founded in 2010[8][9][10] or 2011[11][12] in Cambridge, Massachusetts through Flagship's VentureLabs business incubator program to commercialize an invention made by Derrick Rossi of Boston Children’s Hospital.[9][10]

Moderna’s founders include Noubar Afeyan of Flagship Pioneering, Kenneth R. Chien of Harvard University and the Karolinska Institutet, Robert S. Langer of the Massachusetts Institute of Technology and Rossi.[9]

Stéphane Bancel was recruited as CEO in 2011 and left his role as CEO of BioMérieux to join the company.[10]

It operated in stealth mode until December 2012, with a vague website and all employees working under strict confidentiality agreements.[9][11]

History[edit]

Moderna received venture capital and grant funding of $40 million from Flagship Ventures' VentureLabs unit and other private investors by December 2012.[2][13]

In March 2013, Moderna Therapeutics 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.[14][15] 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."[14]

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.[16][17]

In November 2013, Moderna secured an additional $110M in equity financing to further develop its mRNA Therapeutics platform as a private company.[18] In January 2014, Moderna and Alexion Pharmaceuticals entered a $125 million deal to aid in the discovery and development of messenger RNA therapeutics used to treat rare 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.[19]

In June 2014, CNBC recognized Moderna as one of the top 50 companies whose innovations are having a dramatic impact across their industries, and are poised for hyper-growth.[20]

In October 2014, Moderna announced a strategic 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.[21]

At the beginning of January 2015, Moderna announced that it had raised $450 million in new funding to support further expansion of its mRNA Therapeutics platform across multiple modalities and therapeutic areas. As of this announcement, Moderna had secured $950 million in funding through financing activities and commercial partnerships.[22]

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.[23]

Also in January 2015, Moderna announced a license and collaboration agreement with Merck for the discovery and development of vaccines and passive immunity treatments against viral diseases using modified messenger RNA (mRNA). 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.[24]

In May 2015, Moderna launched Elpidera, a venture focused exclusively on developing messenger RNA (mRNA) based medicines for the treatment of rare diseases.[25]

Also in May 2015, CNBC recognized Moderna the #1 Disruptor on its third-annual CNBC Disruptor 50 list.[26]

On October 22, 2015, Moderna launched its fourth venture, Caperna, focused exclusively on the advancement of personalized cancer vaccines.[27]

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.[28]

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.[29]

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.[30]

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.[31]

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.[32]

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).[33]

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.[34]

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.[35]

In September 2016, Moderna announced that it was going to start building a 200,000 sq ft GMP mRNA manufacturing facility in Norwood, Mass.[36][37]

References[edit]

  1. ^ Kyle Alspach (May 22, 2013). "Moderna CEO Bancel joins Flagship Ventures as senior partner". Boston Business Journal. Retrieved Dec 11, 2013. 
  2. ^ a b Catherine Shaffer (December 6, 2013). "Moderna Makes Entrance with $40M Round for mRNA Work". BioWorld. Retrieved Dec 11, 2013. 
  3. ^ "Modified mRNA directs the fate of heart progenitor cells and induces vascular regeneration after myocardial infarction". Nature Biotechnology. 31: 898–907. September 8, 2013. doi:10.1038/nbt.2682. Retrieved Dec 11, 2013. 
  4. ^ Meghan Sullivan (January 28, 2013). "Moderna: Funding the messenger". BioCentury. Retrieved Dec 11, 2013. 
  5. ^ "Moderna: Our Pipeline"
  6. ^ "Moderna: Drug Modalities"
  7. ^ "Moderna: Management Team"
  8. ^ Kutz, Erin (4 October 2010). "ModeRNA, Stealth Startup Backed By Flagship, Unveils New Way to Make Stem Cells | Xconomy". Xconomy. 
  9. ^ a b c d Catherine Elton (March 2013). "The NEXT Next Big Thing". Boston Magazine. Retrieved Dec 11, 2013. 
  10. ^ a b c Peter Cohan (July 12, 2013). "After $240 Million AstraZeneca Deal, How Big Will Moderna Get?". Forbes. Retrieved Dec 11, 2013. 
  11. ^ a b Michael Farrell (December 6, 2012). "New Cambridge biotech comes out of stealth mode". Boston Globe. Retrieved Dec 11, 2013. 
  12. ^ Galen Moore (March 21, 2013). "Here's why AstraZeneca CEO Pascal Soriot is betting huge on a tiny Cambridge biotech". Boston Business Journal. Retrieved Dec 11, 2013. 
  13. ^ Gregory Huang (December 6, 2012). "Moderna, $40M in Tow, Hopes to Reinvent Biotech with "Make Your Own Drug"". Xconomy. Retrieved Dec 11, 2013. 
  14. ^ a b Andrew Pollack (March 21, 2013). "AstraZeneca Makes a Bet on an Untested Technique". New York Times. Retrieved Dec 11, 2013. 
  15. ^ Robert Weisman (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Retrieved Dec 11, 2013. 
  16. ^ Emily Mullin (October 2, 2013). "Moderna lands $25M grant to develop its RNA platform against infectious diseases, bioterror". Fierce Biotech. Retrieved Dec 11, 2013. 
  17. ^ Luke Timmerman (October 2, 2013). "Moderna Snags $25M DARPA Grant to Fight Pandemics With mRNA Drugs". Xconomy. Retrieved Dec 11, 2013. 
  18. ^ http://blogs.wsj.com/venturecapital/2013/11/20/the-daily-startup-moderna-to-advance-messenger-rna-therapies-privately-despite-ipo-market/
  19. ^ Reidy, Chris. "Alexion, Moderna announce agreement to develop messenger RNA therapeutics . Boston Globe. January 13, 2014.
  20. ^ CNBC. "CNBC's Disruptor 50. CNBC. June 17, 2014.
  21. ^ Press release. "Moderna to Collaborate with Karolinska Institutet and Karolinska University Hospital on Discovery of New Messenger RNA Therapeutics™. October 16, 2014.
  22. ^ Press release. "Moderna Closes $450 Million Financing to Support Growth of Messenger RNA Therapeutics™ Platform across Diverse Therapeutic Areas". January 5, 2015.
  23. ^ Press release. "Moderna Launches New Venture Valera LLC for Infectious Diseases". January 8, 2015.
  24. ^ Press release. "Moderna Announces License and Collaboration Agreement with Merck to Develop Messenger RNA-based Antiviral Vaccines and Passive Immunity Therapies". January 13, 2015.
  25. ^ Press release. "Moderna Launches Third Venture Company Elpidera for Rare Diseases". May 12, 2015.
  26. ^ CNBC. "CNBC's Disruptor 50. CNBC. May 12, 2015.
  27. ^ Ben Fidler (October 22, 2015). "With New Startup, Caperna, Moderna Gets in on Cancer Vaccine Buzz". Xconomy. Retrieved January 4, 2016. 
  28. ^ 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. 
  29. ^ Sten Stovall (January 11, 2016). "AstraZeneca Ups Betting Ante On Moderna's Messenger RNA Technology". Scrip. Retrieved January 11, 2016. 
  30. ^ 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. 
  31. ^ Stacy Lawrence (June 29, 2016). "Merck, Moderna tie up in $200M deal to develop mRNA-based ‘personalized’ cancer vaccines". FierceBiotech. Retrieved June 29, 2016. 
  32. ^ 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. 
  33. ^ Ben Adams (July 26, 2016). "Cash-rich Moderna to begin first AstraZeneca trial under collab deal". FierceBiotech. Retrieved July 26, 2016. 
  34. ^ GEN (September 7, 2016). "Moderna Wins Up to $125M from BARDA toward Zika mRNA Vaccine". Genetic Engineering & Biotechnology News. Retrieved September 7, 2016. 
  35. ^ GEN (September 7, 2016). "Moderna Wins Up to $125M from BARDA toward Zika mRNA Vaccine". Genetic Engineering & Biotechnology News. Retrieved September 7, 2016. 
  36. ^ Eric Palmer (September 21, 2016). "Moderna lays out ambitious $110M facility for clinical supplies". FierceBiotech. Retrieved September 21, 2016. 
  37. ^ John Carroll (September 21, 2016). "Biotech unicorn Moderna gambles $110M on a groundbreaking mRNA manufacturing facility, blueprints plant #2". Endpoints. Retrieved September 21, 2016. 

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