Date: 2011-11-08
Type of information: Initiation of preclinical development
phase: 2
Announcement:
Company: Bavarian Nordic (Denmark)
Product: CV301
Action
mechanism: immunotherapy product. CV301 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. Disease:
Therapeutic
area: Cancer Oncology Country:
Trial
details: Latest
news: Bavarian Nordic has 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. 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.
