Moderna

from Wikipedia, the free encyclopedia
Moderna, Inc.

logo
legal form Inc.
ISIN US60770K1079
founding September 2010 (as ModeRNA Therapeutics)
Seat Cambridge, Massachusetts
management Stéphane Bancel (CEO)
Number of employees 830
sales 60 million US dollars
Branch biotechnology
Website www.modernatx.com
As of December 31, 2019

Moderna, Inc. is a Cambridge , Massachusetts- based biotechnology company focused on the discovery and development of messenger RNA ( mRNA ) drugs . The company makes synthetic mRNA that can be injected into patients.

Company history

Moderna was founded in 2010 under the name "ModeRNA". It is based on research from Harvard University by Derrick Rossi, who developed a method to modify mRNA, transfect it into human cells and “dedifferentiate” mRNA into stem cells, which then differentiated into the desired cell types. Rossi then reached out to Harvard faculty member Tim Springer, who became Moderna's first investor, and Kenneth R. Chien and Bob Langer as co-founders, followed by a meeting with Noubar Afeyan, CEO of Flagship Ventures, about the capitalize new businesses. After further validation of the experiments carried out in Rossi's laboratory, the company started operations in 2011 under the leadership of Stéphane Bancel as CEO.

In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop and commercialize mRNA therapeutics for the treatment of cardiovascular, metabolic and kidney diseases as well as selected cancer targets. The agreement included an upfront payment of $ 240 million to Moderna, a payment that was "one of the largest upfront payments in a pharmaceutical industry license agreement that has not tested any drug in clinical trials."

In January 2014, Moderna and Alexion Pharmaceuticals signed a $ 125 million contract for orphan diseases . Alexion paid Moderna $ 100 million for 10 product options to develop rare disease drugs using Moderna's mRNA Therapeutics platform.

In January 2016, Moderna announced the start of a Phase 1 clinical trial for mRNA 1440 in Europe and submitted an Investigational New Drug Application to the Food and Drug Administration (FDA) for the development of mRNA vaccines against infectious diseases.

Product development

All Moderna products are currently in clinical trials . A wide variety of mRNA drugs are in the clinical programs. Including an RNA vaccine against the SARS-CoV-2 virus. Vaccines and therapeutics for rare diseases such as methylmalonic aciduria (MMA) and propionic acidemia (PA) are currently in product development .

Moderna is also researching personalized cancer vaccines.

Vaccine development against the corona virus

In January 2020, Moderna announced the development of a vaccine to inhibit the COVID-19 virus disease. In March 2020, the phase I study of the vaccine candidate in humans began in collaboration with the US National Institute of Allergy and Infectious Diseases . This made Moderna the first company in the world to have a clinical trial approved for a SARS-CoV-2 vaccine . The usual animal studies were skipped. The US Food and Drug Administration (FDA) appears to be relying on preclinical testing of vaccines made on the same platform against the first SARS coronavirus and against the MERS coronavirus , without any safety issues. Initial statements on immunity are available. After the vaccine has generated sufficient antibody titers , a phase 2 study will be carried out on a larger number of subjects. A phase 3 study with dosages between 25 µg and 100 µg is expected to begin on July 27th

Production facilities

In July 2018, Moderna opened its manufacturing facility in Norwood, Massachusetts . There, mRNA-based active ingredients can be produced under GMP conditions at an early stage of their scale-up. The capacity is planned for more than 100 batches per year for phases I + II of a drug study . To expand its production capacity, especially for the COVID-19 vaccine candidate mRNA-1273 and other future products, it has announced the conclusion of a 10-year agreement with the Lonza Group . Technology transfer is slated to begin in June 2020, with the first batches of mRNA-1273 expected to be manufactured at Lonza's US facility in July 2020. Through further transfers, the production capacity for mRNA-1273 is to be increased to one billion doses annually - calculated to an amount of 50 µg per dose .

Web links

Individual evidence

  1. ↑ SEC-Filing Form 10-K. Retrieved June 4, 2020 .
  2. ↑ Moderna Makes Entrance with $ 40M Round for mRNA Work. Accessed April 25, 2020 (English).
  3. ↑ Vaccines. Retrieved April 25, 2020 .
  4. ↑ Xconomy: ModeRNA, Stealth Startup Backed By Flagship, Unveils New Way to Make Stem Cells. October 4, 2010, accessed April 25, 2020 .
  5. ↑ a b Xconomy: Moderna, $ 40M in tow, Hopes to Reinvent Biotech with "Make Your Own Drug". December 6, 2012, accessed April 25, 2020 .
  6. ↑ Does Moderna Therapeutics Have the Next Big Thing in Medicine? In: Boston Magazine. February 26, 2013, Retrieved April 25, 2020 (American English).
  7. ^ A b Andrew Pollack: AstraZeneca Makes a Bet on an Untested Technique . In: The New York Times . March 21, 2013, ISSN  0362-4331 ( nytimes.com [accessed April 25, 2020]).
  8. ↑ Robert Weisman Globe Staff, March 21, 2013, 12:00 am Email to a Friend Share on Facebook Share on TwitterPrint this Article View Comments: Moderna in line for $ 240m licensing deal - The Boston Globe. Retrieved April 25, 2020 (American English).
  9. ↑ Alexion, Moderna announce agreement to develop messenger RNA therapeutics | Boston.com. Retrieved April 25, 2020 (American English).
  10. ↑ Booming Moderna Eyes Six Human Trials in 2016, Inks Deals with AstraZeneca PLC, Merck & Co. and Signed Huge Lease in Cambridge for R&D Growth. Retrieved April 25, 2020 (American English).
  11. ↑ Research Pipeline: MMA, CMV, Zika & Rare Diseases - Moderna. Retrieved April 25, 2020 .
  12. ↑ Modalities: mRNA Vaccines, Modalities & Therapeutics - Moderna. Retrieved April 25, 2020 .
  13. ^ Ulrich Martin: The Biologics News and Reports Portal. Retrieved April 25, 2020 (UK English).
  14. ↑ SARS-CoV-2: First vaccine study has started in the USA , Ärzteblatt, March 17, 2020. Accessed on May 19, 2020.
  15. ↑ PM: Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus , May 18, 2020. Accessed May 19, 2020.
  16. ↑ Data support 30,000 participant Phase 3 study expected to begin on July 27 , accessed on July 15, 2020
  17. ^ Moderna Therapeutics Clinical Manufacturing Facility, Norwood, Massachusetts
  18. ↑ early-development company information Moderna
  19. ↑ Moderna Taps Lonza to Scale Up Manufacturing of COVID-19 Vaccine by: Genetic Engineering & Biotechnology News (GEN)