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, 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.
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, 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 and in the European Union, where it is marketed as Imvanex. 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 was approved by the U.S. Food and Drug Administration in September 2019. Jynneos was formerly known as MVA-BN.
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. Vaccinia-fowlpox-TRICOM is a sequential prime-boost therapy based on vaccinia and fowlpox in combination with three co-stimulatory molecules. The poxvirus-based immunotherapy can be modified to encode different tumor-associated antigens such as Prostate-specific antigen, Carcinoembryonic antigen and/or Mucin 1, 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 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. 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. It was approved for medical use in the European Union in July 2020.Aquisition af rabies- and TBE-vaccines from GSK
Following announcement of GlaxoSmithKline on 21st October 2019, Bavarian Nordic acquired 2 vaccines from the traveler portfolio of GSK Vaccines: Rabipur and Encepur.Marketed Products and Pipeline
Bavarian Nordic's marketed products and pipeline, as of July 2020.| Product | Indication | Phase | Remark |
| Imvanex | smallpox | Approved EU 2013-07 | Liquid-frozen. |
| Imvamune | smallpox | Approved Canada 2013-11 | Liquid-frozen. |
| Jynneos | smallpox and monkeypox | Approved US 2019-08-24 | Liquid-frozen. |
| MVA-BN | smallpox | III | Ph3 lot-consistency study ongoing with anticipated completion in 2021. |
| Rabipur/RabAvert | rabies | Approved | Acquisition completed 2019-12-31. BN assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020-25 - during this period BN will purchase remaining inventory of vaccines from GSK at different levels in the supply chain. |
| Encepur | European tick-borne encephalitis virus | Approved | Acquisition completed 2019-12-31. BN assumes full sales and marketing responsibility from start 2020; manufacturing transfer takes place 2020-25 - during this period BN will purchase remaining inventory of vaccines from GSK at different levels in the supply chain. |
| Mvabea | Ebola and Marburg virus | Approved EU 2020-07-01 | Licensed to Janssen. One dose of Janssen's primer Zabdeno® followed 8 weeks later by a dose of BN's booster Mvabea® collectively constitutes Janssen's Ebola vaccine regimen. |
| MVA-BN RSV | RSV | II | Ph2 results announced on August 8, 2018. 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 BN will expand 2nd part of Ph3 study, which will start up winter 2022-23. |
| MVA-BN HPV | Chronic HPV infection | II | Licensed to Janssen. Phase 1/2a study ongoing. |
| MVA-BN WEV | Western equine encephalitis virus | I | Ph1 topline results announced June 8, 2020. BN is currently in the process of obtaining additional funding from the U.S. authorities for the further clinical advancement of the vaccine candidate. |
| BN-Brachyury | Chordoma | II | Report 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.