Bavarian Nordic Obtains Rights to New Cancer Vaccine Product Candidates
Includes rights to immunotherapy product candidate for multiple cancer indications; data from ongoing NCI-sponsored Phase 2 study in breast cancer expected in first half of 2012.
Kvistgård, Denmark, October 5, 2011 - Bavarian Nordic A/S (OMX: BAVA) today 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.
About Poxviruses and Immunotherapy
Although increased expression of tumor associated antigens, such as PSA, CEA, and MUC-1, is associated with advanced disease these antigens do not sufficiently activate the immune system to attack cancer cells. To overcome this poor responsiveness, recombinant poxvirus vectors, including vaccinia, fowlpox and modified vaccinia Ankara (MVA), can be genetically engineered to express one or more tumor-associated antigens to greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens.
About CVAC-301 and PROSTVAC®
Both PROSTVAC® and CVAC-301 are prime-boost vaccines, sequentially combining two different poxviruses (vaccinia and fowlpox). Collectively, these two product candidates have been the subject of over 30 clinical trials in more than 1,000 patients with prostate, breast, lung, colorectal, gastric, pancreatic, ovarian, and other cancers. These extensive clinical studies suggest a favorable safety and tolerability profile for poxvirus-based vaccines along with immunologic responses directed against the relevant tumor-associated antigens.
Further information and a list of scientific publications on CVAC-301 can be found on the Company's website: /cvac-301
A conference call will be held today, 5 October 2011 at 6 p.m. CET (12 p.m. EST) with Anders Hedegaard, President & CEO, Reiner Laus, CEO of BN ImmunoTherapeutics Inc. and Rolf Sass Sørensen, Vice President Investor Relations & Communications. The conference call will begin with a presentation of CVAC-301 and the expanded NCI collaboration, followed by a Q&A session. Dial-in numbers for the conference call are: UK: +44 (0)20 7162 0077. USA: +1 334 323 6201. The accompanying presentation is available on the company's website: /cvac-301.