Bavarian Nordic Obtains Rights to New Cancer Vaccine Product Candidates

11-10-2011: Bavarian Nordic A/S announced that its BN ImmunoTherapeutics subsidiary has 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.

"This agreement marks a major step forward for Bavarian Nordic as the product candidate and technology platform significantly expand our cancer vaccine portfolio and enhances our position as a leader in recombinant immunotherapies for the treatment and prevention of life-threatening diseases," said Reiner Laus, President of the Cancer Vaccine Division. "As already shown with PROSTVAC® in prostate cancer and CVAC-301 in other cancer indications, this technology platform holds great promise in the future treatment of patients with several types of cancers who today face a limited number of treatment alternatives. Also, we are strengthening our ties with the National Cancer Institute - a world leader in cancer research, and we look forward to collaborating with the experienced staff at NCI on the development of new cancer vaccines for the benefit of even more cancer patients."

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.