Bavarian Nordic Ebola vaccine candidate to enter into clinical trials

The 2014 West African Ebola outbreak and the ensuing global public health emergency have spurred significant government interest in the development of vaccines and treatments. For Bavarian Nordic, headquartered in Kvistgaard, Denmark, this has resulted in ramping up its Ebola vaccine development through a new collaboration with Janssen. Bavarian Nordic is a member of the American Danish Business Council.

Bavarian Nordic is most well known for its smallpox vaccine, IMVANEX, which is approved in the European Union and Canada and is supplied to stockpiles around the world in case of a deliberate or natural re-emergence of the smallpox virus. Like smallpox, Ebola has long been considered a high-priority biological threat by the U.S. and other governments. Bavarian Nordic has been working with the U.S. National Institutes of Health since 2010 on adapting its smallpox vaccine platform for viruses like Ebola and Marburg.

The latest emergence of Ebola in West Africa this year and the outbreak that has followed – the largest in history – have significantly increased the urgency with which governments, non-governmental organizations, and industry are working to mitigate consequences and prevent future outbreaks.

“The gravity of the situation has called for immediate action from authorities and drug developers to fast-track the development of urgently needed medical countermeasures, and for Bavarian Nordic it is a privilege to join the global effort to combat the current outbreak in West Africa,” said Paul Chaplin, President & CEO of Bavarian Nordic.

In recent preclinical studies, a two-dose vaccine regimen based on MVA-BN® (Bavarian Nordic’s proprietary vaccine platform) and Johnson & Johnson’s AdVac® technology has shown very encouraging results. Protection against Ebola Zaire – the virus strain responsible for the current outbreak – has been demonstrated at 100%. With this early success, Bavarian Nordic and Johnson & Johnson have now formally joined forces to advance the development of this promising approach through a collaboration agreement, whereby Bavarian Nordic has granted Johnson & Johnson an exclusive license for its Ebola vaccine. Further, Johnson & Johnson has invested US$ 43 million (DKK 251 million) to subscribe for approximately 1.3 million new shares in Bavarian Nordic; the total value of the deal exceeds US$ 187 million.

Phase 1 clinical trials, designed to demonstrate vaccine safety, are scheduled to begin by January 2015. Meanwhile, Bavarian Nordic has begun scaling up to produce the new vaccine, and is targeting to manufacture more than 1 million doses in 2015. Johnson & Johnson is also working closely with authorities to potentially make the vaccines available for emergency use to help contain the current outbreak in West Africa.

 

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