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Clinical Trials

Date: 2013-05-29

Type of information: Initiation of preclinical development

phase: 2

Announcement: publication of data in the Annals of Surgery

Company: Bavarian Nordic (Denmark)

Product: CV301 (CEA/MUC-1/TRICOM)

Action mechanism:

CV301 (CEA/MUC-1/TRICOM) is an immunotherapy product candidate. 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.

Disease: metastatic colorectal cancer

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

Latest news:

* On May 29, 2013, Bavarian Nordic has announced that  data from a Phase 2 trial of its CV301 cancer immunotherapy candidate in patients with resected metastatic colorectal cancer were recently published in the Annals of Surgery. In a study conducted at Duke University, 74 patients who were disease free after surgical resection of metastatic colon cancer received chemotherapy  followed by immunotherapy with CV301 (formerly designated as PANVAC-VF) either as CV-301 modified dendritic cells or in combination with GM-CSF. Compared to a group of contemporary control patients who were matched for key clinical features and had similar surgery and chemotherapy, the overall survival of the CV-301 treated patients was significantly longer (p < 0.0001). Treatment with CV-301 was well tolerated, with injection site reactions, fever, fatigue and muscle soreness as the most common side effects.
Bavarian Nordic has expanded its license with the National Cancer Institute (NCI) for CV-301 to include colon cancer. The original collaboration agreement was executed in 2011, and involved multiple cancers including breast, lung, ovarian and other cancers. Bavarian Nordic is now looking forward to assessing the complete CV-301 portfolio and expects to present the future development strategy later this year.

Is general: Yes