Bavarian Nordic

Bavarian Nordic A/S
Publicly traded Aktieselskab
Traded as Nasdaq Copenhagen: BAVA
Industry Biotechnology
Founded 1994
Headquarters Kvistgård, Denmark, Redwood City, California and Martinsried, Germany
Key people
Products Imvanex
Number of employees
  • Decrease 409 (end 2015)
  • 422 (end 2014)[3]:16
Website www.bavarian-nordic.com

Bavarian Nordic is a biotechnology company specializing in research, development and manufacture of active 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. Research and development facilities are located in Redwood City, California, USA, and Martinsried, Germany.

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,[4] 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[5] and in the European Union, where it is marketed as Imvanex.[6] The vaccine is being supplied for emergency use to the U.S. Strategic National Stockpile as well as other government stockpiles. Registration studies for the approval in the U.S. are currently underway.

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 forms the basis of the company’s lead oncology product candidates, Prostvac and CV-301. Prostvac is an active immunotherapy candidate, currently the subject of a global Phase 3 clinical study “PROSPECT”[7] in men with asymptomatic or minimally symptomatic castration-resistant prostate cancer.

Ebola vaccine development and production

The company has worked for several years with the NIAID[8] 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.[9][10][11] 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.[12]

Pipeline

Bavarian Nordic's pipeline, as of June 2016.[13]

Product Indication Phase
Imvanex smallpox Approved
Prostvac prostate cancer III
MVA-BN Filo Ebola and Marburg virus III
CV-301 bladder cancer II
MVA-BN Brachyury solid tumors I
MVA-BN RSV RSV I
MVA-BN HPV Chronic HPV infection Preclinical

In addition, the company has multiple pre-clinical projects based on its MVA-BN technology targeting infectious diseases.

References

  1. ↑ "Management". Bavarian Nordic. Retrieved 2014-10-29.
  2. ↑ "Board of Directors". Bavarian Nordic. Archived from the original on 2015-04-07. Retrieved 2015-04-07.
  3. ↑ "Annual Report 2015" (PDF). Bavarian Nordic. Retrieved 2016-04-07.
  4. ↑ Kennedy JS, Greenberg RN (9 January 2014). "IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine". Expert Reviews of Vaccines. 8 (1): 13–24. doi:10.1586/14760584.8.1.13. PMID 19093767. (subscription required (help)).
  5. ↑ "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.
  6. ↑ "Imvanex". Human Medicines. European Medicines Agency. 27 May 2016. Retrieved 2016-06-12.
  7. ↑ "A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)". ClinicalTrials.gov. U.S. National Institutes of Health. Retrieved 2014-06-26.
  8. ↑ "Infectious Diseases: Filovirus Vaccine". Bavarian Nordic. Retrieved 2014-10-29.
  9. ↑ "Bavarian Nordic Enters Licensing and Supply Agreement with Janssen on MVA-BN® Ebola Vaccine". Bavarian Nordic. 2014-10-22. Retrieved 2014-10-29.
  10. ↑ "BRIEF-Bavarian Nordic to expand collaboration with Janssen". reuters-brief. Reuters. 2014-10-23. Retrieved 2014-10-29.
  11. ↑ "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.
  12. ↑ "J&J, Bavarian Nordic start clinical tests in Ebola vaccine race". Reuters. Reuters. 2015-01-06. Retrieved 2015-01-12.
  13. ↑ "Pipeline". Bavarian Nordic. Retrieved 2016-06-17.


External links

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