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Agreements

Date: 2011-10-05

Type of information: R&D agreement

Compound: new off-the-shelf product candidates for the treatment of multiple cancers and a new technology platform based on NCI\\\'s cancer vaccine technology

Company: Bavarian Nordic (Denmark) National Cancer Institute (USA)

Therapeutic area: Cancer - Oncology

Type agreement: research - R&D - licensing

Action mechanism:

Disease:

Details: Bavarian Nordic A/S and its BN ImmunoTherapeutics subsidiary have entered into an expanded strategic partnership with the National Cancer Institute (NCI). Under the licensing and Cooperative Research and Development Agreements (CRADA), the NCI and Bavarian Nordic will jointly develop new off-the-shelf product candidates for the treatment of multiple cancers and a new technology platform based on NCI\'s cancer vaccine technology. Through the expanded collaboration with the NCI and license with the National Institutes of Health (NIH), the Company has obtained certain rights to CVAC-301 (formerly developed as PANVAC), an off-the-shelf, cancer immunotherapy product candidate. CVAC-301 originates from the same poxvirus technology platform as PROSTVAC®, the Company\'s lead product candidate licensed from the NIH in 2008 and also being developed in collaboration with NCI under a CRADA. While PROSTVAC® incorporates a single antigen overexpressed in prostate cancer (PSA), CVAC-301 incorporates two antigens (CEA and MUC-1) that are overexpressed in other major cancers, including breast, lung, and ovarian, which makes CVAC-301 potentially applicable in various cancers. CVAC-301 is currently the subject of an NCI-sponsored, randomized Phase 2 study of docetaxel alone or in combination with CVAC-301 in metastatic breast cancer with data expected in the first half of 2012. Under the agreement the Company will manufacture additional vaccine constructs for the NCI. As part of this collaborative effort, NCI will fund and conduct certain preclinical and clinical studies to evaluate the product candidates alone and in combination with other modalities. The funding can include Phase 3 studies. The licensing cost of CVAC-301 does not affect the company\'s expectations for the financial results for 2011. In addition, due to CVAC-301\'s advanced stage of development and broader applicability beyond HER2+ breast cancer, the company expects to reassess earlier-stage pipeline programs, such as MVA-BN® HER2, following the completion of ongoing studies.

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Is general: Yes