Bavarian Nordic A/S establishes two new operations in the USA and re-starts activities in cancer immunotherapy.
Bavarian Nordic A/S announces that it is establishing activities in the US in a two-step process. Bavarian Nordic A/S sets up a holding company in the USA, Bavarian Nordic Inc. which based in Delaware will serve as legal entitiy for future activities in the US. Furthermore, Bavarian Nordic A/S establishes an operating company, BN ImmunoTherapeutics Inc. for research and development of cancer vaccines, initially against breast, prostate and colon cancers. BN ImmunoTherapeutics will have its base in the Palo Alto area of California and scientific activities are expected to begin in January 2005.
Bavarian Nordic A/S will initially invest DKK 26 million (USD 4 million). Further funding hereafter will be injected as necessary.
Both the holding company, Bavarian Nordic Inc., and the operating company, BN ImmunoTherapeutics Inc. will be wholly-owned subsidiaries of Bavarian Nordic A/S.
Bavarian Nordic’s decision to re-start activities with cancer vaccines follows the company’s recent progress within cancer immune therapy. New data from an earlier clinical study in melanoma cancer with a Bavarian Nordic trial vaccine based on the MVA-F6 vector expressing the melanoma antigen, tyrosinase, demonstrate that the MVA-vector is able to break tolerance towards the self-antigen and induce a prolonged relevant therapeutic immune response over a period of more than a year.
Bavarian Nordic has over many years collaborated with a group at Instituto Nazionale Tumori, which is Italy’s largest cancer hospital in Milan, headed by Professor Alessandro Gianni in the MVA-F6 tyrosinase programme. Professor Gianni has agreed to act as a scientific advisor for Bavarian Nordic’s Board and Management.
BN ImmunoTherapeutics Inc. will perform its research and development of cancer vaccines in the Palo Alto area of California to facilitate collaboration with nearby universities that are known to be leaders in field of cancer immunology. BN ImmunoTherapeutics Inc. will initially focus on research, preclinical and clinical development activities while relying on Bavarian Nordic’s operations in Europe for virology, clinical batch manufacturing and quality management.
BN ImmunoTherapeutics Inc. will be led by Dr. Reiner Laus, who was until recently the Vice President of Research & Development at Dendreon Corporation in Seattle, Washington.
Peter Wulff, President and CEO commented, “We are now establishing a base in the US and are engaging in a strong R&D group for development of new vaccines for the treatment of cancer diseases. The combination of new and promising data from our earlier cancer projects, the strong safety profile of our MVABN® technology and a solid financial position has lead to this expansion of our business and research area.
We are very pleased to have secured the expertise and leadership of Dr. Laus for BN ImmunoTherapeutics Inc. The activities of BN ImmunoTherapeutics Inc. will have high priority and we anticipate that by 2006 we will be in the position to file an Investigational New Drug (IND) application.”
The board of directors of the holding company, Bavarian Nordic Inc, will consist of Peter Wulff, President and CEO of Bavarian Nordic A/S as Chairman and Hans Christian Teisen, Executive Vice President of Bavarian Nordic A/S as CEO.
The board of directors of BN ImmunoTherapeutics Inc., will include Peter Wulff, President and Chief Executive Officer of Bavarian Nordic as Chairman, Paul Chaplin, Chief Scientific Officer of Bavarian Nordic, Reiner Laus, Chief Executive Officer of BN ImmunoTherapeutics Inc. as well as two yet unnamed internationally recognised experts in the field of cancer research. In addition to the board of directors, the new company will during 2005 establish a scientific advisory board consisting of people with particular scientific expertise in the field of cancer immunotherapy.
About cancer immune therapy The most promising new therapies for cancer are based upon immune therapy approaches. Over the recent years several new cancer drugs based upon passive immune therapy have reached the market. However, the draw back with passive immune therapy is that it relies on only one arm of the immune system; the humoral arm (anti-bodies).
Work on the next generation immune therapies is targeting both arms of the immune system (humoral and cellular arm – T-cells). These approaches are based upon vaccination. Though, currently no such drugs have yet reached the market, several are expected to be approved in the next few years. Bavarian Nordic’s cancer therapy approach is to develop vaccines targeting both the humoral and cellular arm of the immune system.
According to the BioSpace cancer report, the cancer drug market world wide was USD 30 billion in 2003.
Reiner Laus, MD Effective January 1, 2005, Dr Reiner Laus, M.D. will join Bavarian Nordic A/S as Chief Executive Officer of BN ImmunoTherapeutics Inc., which is the company’s new subsidiary in the USA, to focus on cancer vaccine research and development.
Dr. Laus was previously Vice President of Research and Development at Dendreon Corporation in Seattle, Washington. At Dendreon, he was responsible for discovery, pre-clinical and development functions. He lead the discovery and development of Dendreon’s portfolio of therapeutic cancer vaccines, including Provenge®, a therapeutic vaccine for the treatment of prostate cancer currently in Phase III clinical development.
Prior to his position at Dendreon, Dr. Laus was a member of the faculty of the Department of Immunology at the University of Kiel in Germany. He received his Medical Doctor degree from the University of Kiel and was a l fellow at Stanford University in the USA.
Dr. Laus is the author of numerous scientific publications and co-owner/applicant of patents in the field of cancer immunology. He is a member of the American Society of Haematology, American Association of Immunologists, and American Association for Cancer Research.
