Data update from ongoing NCI-sponsored Phase 2 study in breast cancer expected in first half of 2012.
Kvistgård, Denmark, November 8, 2011 - Bavarian Nordic A/S (OMX: BAVA) today announced that encouraging clinical trial results with CV-301 in patients with metastatic breast or ovarian cancer were published in Clinical Cancer Research, a peer-reviewed journal of the American Association for Cancer Research. Through an expanded collaboration with the National Cancer Institute (NCI) and license with the National Institutes of Health (NIH), the Company obtained rights to CV-301, an off-the-shelf cancer immunotherapy product candidate for multiple cancers, in October 2011.
The NCI-funded study enrolled 26 heavily pretreated patients with metastatic breast or ovarian cancer and assigned them to monthly vaccinations with CV-301. Among the 12 patients with breast cancer, median time to progression (TTP) was 2.5 months and median overall survival (OS) was 13.7 months. One breast cancer patient had a complete response and remains on study for 37 months or more. For the 14 patients with ovarian cancer, median TTP was 2 months and median OS was 15 months. Treatment with CV-301 was well tolerated, with mild injection-site reactions representing the most common side effect.
"Approval of the first active immunotherapy for cancer by the U.S. Food and Drug Administration provided definitive proof-of-concept for this class of agents and further demonstrated that overall survival, rather than time to progression or tumor shrinkage, may be a more relevant clinical endpoint in evaluating the effects of immunotherapies," said Reiner Laus, President of the Cancer Vaccine Division. "The sustained benefit seen in some patients receiving CV-301 provides additional insight into the potential of this therapeutic vaccine and we look forward to results from an ongoing randomized Phase 2 study of CV-301 in patients with metastatic breast cancer."
CV-301 originates from the same poxvirus technology platform as PROSTVAC®, the Company's lead product candidate. While PROSTVAC® incorporates a single antigen overexpressed in prostate cancer (PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are overexpressed in other major cancers, including breast, lung, and ovarian, which makes CV-301 potentially applicable in various cancers. CV-301 is currently the subject of an NCI-sponsored, randomized Phase 2 study of docetaxel (chemotherapy) alone or in combination with CV-301 in metastatic breast cancer.
Chairman of the Board
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
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 CV-301 and PROSTVAC®
Both PROSTVAC® and CV-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 CV-301 can be found on the Company's website: http://www.bavarian-nordic.com/cv-301
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases, and includes ten development programmes. Two programmes are under preparation for Phase 3: PROSTVAC®, a therapeutic vaccine for advanced prostate cancer is being developed under a collaboration agreement with the National Cancer Institute, and IMVAMUNE®, a third-generation smallpox vaccine is being developed under a contract with the U.S. Government. For more information please visit www.bavarian-nordic.com.