Bavarian Nordic

Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company is headquartered in Kvistgaard, Denmark (a town in Helsingør Municipality), where it also operates a commercial-scale manufacturing facility. The company has a research and development facility in Martinsried, Germany and an office in Morrisville, North Carolina.

Bavarian Nordic A/S
TypeAktieselskab
Nasdaq Copenhagen: BAVA
IndustryBiotechnology
Founded1994
HeadquartersKvistgård, Denmark, Morrisville, North Carolina and Martinsried, Germany
Key people
ProductsImvanex, Imvamune, Jynneos, Rabipur/RabAvert, Encepur, Mvabea
Total assets1,989,300,000 Danish krone (2015) 
Number of employees
  • 437 (end 2016)
  • 409 (end 2015):16
Websitewww.bavarian-nordic.com

The company uses viral vectors in its research and development.

Technologies

MVA-BN

MVA-BN is a proprietary technology developed by Bavarian Nordic. It is derived from the Modified vaccinia Ankara virus. MVA-BN is characterized by the inability to replicate in human cells,[3] contrary to other vaccinia-based vaccines, which may replicate in humans, thus potentially causing severe and life-threatening side effects. Developed as the non-replicating smallpox vaccine, Imvamune, it is approved in Canada[4] and in the European Union, where it is marketed as Imvanex.[5] The vaccine is being supplied for emergency use to the U.S. Strategic National Stockpile as well as other government stockpiles.

The Jynneos smallpox and monkeypox live, non-replicating vaccine[6] was approved by the U.S. Food and Drug Administration (FDA) in September 2019.[7] Jynneos was formerly known as MVA-BN.[8][9]

Vaccinia-fowlpox-TRICOM

A second poxvirus-based technology is employed in most of the company’s cancer immunotherapies, and was in-licensed as part of a collaboration with the National Cancer Institute (NCI). Vaccinia-fowlpox-TRICOM is a sequential prime-boost therapy based on vaccinia and fowlpox in combination with three co-stimulatory molecules (TRICOM). The poxvirus-based immunotherapy can be modified to encode different tumor-associated antigens such as Prostate-specific antigen (PSA), Carcinoembryonic antigen (CEA) and/or Mucin 1 (MUC1), which are all tumor markers that are overexpressed in various cancers. This technology formed the basis of the company’s lead oncology product candidates, Prostvac and CV-301.

Ebola vaccine development and production

The company has worked for several years with the NIAID[10] on the development of a filovirus vaccine for Ebola and Marburg hemorrhagic fever diseases. In October 2014, following a successful pre-clinical demonstration of the combination vaccine regimen of its multivalent MVA-BN Filovirus vaccine and Crucell/Janssen's AdVac technology based on adenoviral vectors, Bavarian Nordic joined efforts with Crucell Holland B.V., one of the Janssen Pharmaceuticals Companies of Johnson & Johnson to develop and manufacture this vaccine regimen intended for emergency use to help contain the outbreak in West Africa.[11][12][13] In January 2015, the company had produced the first 400,000 doses of the vaccine and the first clinical trial of the vaccine regimen was initiated in the UK, with additional trials planned in the US and Africa.[14] It was approved for medical use in the European Union in July 2020.[15]

Acquisition of rabies- and TBE-vaccines from GSK

Following announcement of GlaxoSmithKline (GSK) on 21st October 2019, Bavarian Nordic acquired 2 vaccines from the traveler portfolio of GSK Vaccines: Rabipur(/Rabavert) and Encepur.[16][17]

Marketed products and pipeline

Bavarian Nordic's marketed products and pipeline, as of July 2020.[18][19]

ProductIndicationPhaseRemark
ImvanexSmallpoxApproved EU 2013-07Liquid-frozen.
ImvamuneSmallpoxApproved Canada 2013-11Liquid-frozen.
JynneosSmallpox and monkeypoxApproved US 2019-08-24Liquid-frozen.
MVA-BN (freeze-dried)SmallpoxIIIPh3 lot-consistency study ongoing with anticipated completion in 2021.
Rabipur/RabAvert(Pre-/post-exposure protection against) rabiesApprovedAcquisition completed 2019-12-31. Bavarian Nordic assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020-25 - during this period Bavarian Nordic will purchase remaining inventory of vaccines from GSK at different levels in the supply chain.
EncepurEuropean (Western) tick-borne encephalitis (TBE) virusApprovedAcquisition completed 2019-12-31. Bavarian Nordic assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020-25 - during this period Bavarian Nordic will purchase remaining inventory of vaccines from GSK at different levels in the supply chain.
MvabeaEbola and Marburg virusApproved EU 2020-07-01Licensed to Janssen. One dose of Janssen's primer Zabdeno® (Ad26.ZEBOV) followed 8 weeks later by a dose of Bavarian Nordic's booster Mvabea® (MVA-BN Filo) collectively constitutes Janssen's Ebola vaccine regimen.
MVA-BN RSVRSVIIPh2 results announced on August 8, 2018.[20] After discussing the design of the Ph3 study with the FDA, its initiation is planned for winter 2021-22. Initial data read-out in 2022 - if data are good Bavarian Nordic will expand second part of Ph3 study, which will start up winter 2022-23.
MVA-BN HPVChronic HPV infectionIILicensed to Janssen. Phase 1/2a study ongoing.
MVA-BN WEVWestern equine encephalitis virusIPh1 topline results announced June 8, 2020.[21] Bavarian Nordic is currently in the process of obtaining additional funding from the U.S. authorities for the further clinical advancement of the vaccine candidate.
BN-BrachyuryChordomaIIReport initial ORR results from Ph2 study of BN-Brachyury in chordoma during 2020.

Bavarian Nordic is a member of the Alliance for Biosecurity, a group of companies that work towards preventing and treating severe infectious diseases, especially those that present global security challenges.[22]

References
  1. "Executive Management". BN. Retrieved 2020-07-15.
  2. "Board of Directors". BN. Retrieved 2020-07-15.
  3. Kennedy JS, Greenberg RN (9 January 2014). "IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine". Expert Review of Vaccines. 8 (1): 13–24. doi:10.1586/14760584.8.1.13. PMID 19093767.
  4. "Products for Human Use. Submission #144762". Register of Innovative Drugs. Health Canada. 13 June 2014. 144762 (Submission Number). Archived from the original on 17 June 2014. Retrieved 2014-06-26.
  5. "Imvanex". Human Medicines. European Medicines Agency. 27 May 2016. Retrieved 2016-06-12.
  6. "Jynneos". U.S. Food and Drug Administration (FDA). 24 September 2019. STN 125678. Archived from the original on 17 October 2019. Retrieved 16 October 2019. This article incorporates text from this source, which is in the public domain.
  7. "FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox". U.S. Food and Drug Administration (FDA). 24 September 2019. Archived from the original on 17 October 2019. Retrieved 17 October 2019. This article incorporates text from this source, which is in the public domain.
  8. "Smallpox Vaccine Supply & Strength". National Institute of Allergy and Infectious Diseases (NIAID). 26 September 2019. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  9. Greenberg RN, Hay CM, Stapleton JT, Marbury TC, Wagner E, Kreitmeir E, Röesch S, von Krempelhuber A, Young P, Nichols R, Meyer TP, Schmidt D, Weigl J, Virgin G, Arndtz-Wiedemann N, Chaplin P (2016). "A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN) in 56-80-Year-Old Subjects". PLoS ONE. 11 (6): e0157335. doi:10.1371/journal.pone.0157335. PMC 4915701. PMID 27327616.
  10. "Infectious Diseases: Filovirus Vaccine". Bavarian Nordic. Archived from the original on 2014-10-30. Retrieved 2014-10-29.
  11. "Bavarian Nordic Enters Licensing and Supply Agreement with Janssen on MVA-BN® Ebola Vaccine". Bavarian Nordic. 2014-10-22. Archived from the original on 2014-11-03. Retrieved 2014-10-29.
  12. "BRIEF-Bavarian Nordic to expand collaboration with Janssen". reuters-brief. Reuters. 2014-10-23. Retrieved 2014-10-29.
  13. "Johnson & Johnson plans Ebola vaccine testing". AP.org. AP News. 2014-10-22. Archived from the original on 2014-10-31. Retrieved 2014-10-29.
  14. "J&J, Bavarian Nordic start clinical tests in Ebola vaccine race". Reuters. Reuters. 2015-01-06. Retrieved 2015-01-12.
  15. "Johnson & Johnson Announces European Commission Approval for Janssen's Preventive Ebola Vaccine". Reuters. Reuters. 2020-07-01. Retrieved 2020-07-16.
  16. Smith, Anna (2019-10-21). "GSK to divest Rabipur, Encepur to Bavarian Nordic". PharmaTimes. Retrieved 2020-04-03.
  17. "GSK agrees to divest rabies and tick-borne encephalitis vaccines to Bavarian Nordic | GSK". www.gsk.com. Retrieved 2020-04-03.
  18. "Pipeline". Bavarian Nordic. 2020-02-20. Retrieved 2020-07-14.
  19. "Annual Report 2019, Pipeline (p.30)" (PDF). Bavarian Nordic. Retrieved 2020-07-15.
  20. "Bavarian Nordic Announces Positive Data from Phase 2 Extension Study of its Universal RSV Vaccine". Bavarian Nordic. 2018-08-08. Retrieved 2020-07-15.
  21. "Bavarian Nordic Announces Topline Results from Phase 1 Clinical Trial of Equine Encephalitis Virus Vaccine". Bavarian Nordic. 2020-06-08. Retrieved 2020-07-15.
  22. "Alliance for Biosecurity". Alliance for Biosecurity. Retrieved 2017-02-02.


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