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Bavarian Nordic initiates Phase 2 trial

Bavarian Nordic production

Bavarian Nordic announces a new Phase 2 study, exploring the combination of its cancer vaccine, CV301 and Bristol-Myers Squibb’s nivolumab (OPDIVO) in patients with metastatic colorectal cancer (mCRC).

CV301 is specifically designed to elicit T-cells against the tumor antigens CEA and MUC1, both of which are highly overexpressed in colorectal cancers.

The Phase 2 randomized trial will enroll up to 74 patients with oligometastatic, microsatellite stable mCRC eligible for complete resection. Prior to surgical removal of their tumors, patients will be randomized to receive four cycles of either chemotherapy plus nivolumab or a combination of chemotherapy, nivolumab, and CV301. After resection, patients will continue receiving respective treatments in each study arm. The trial, anticipated to begin enrolment before mid-year, will be led by Darren R. Carpizo, M.D., Ph.D., Director of the Liver Cancer and Bile Duct Cancer Program at Rutgers Cancer Institute in New Jersey.

“To date, there are no checkpoint inhibitors approved for the treatment of microsatellite stable colorectal cancer. This trial marks an important step in exploring indications where checkpoint inhibitors have not been successful as a monotherapy,” said Paul Chaplin, President and CEO of Bavarian Nordic remarked. “We believe that CV301 – with its ability to elicit T-cells against specific tumor antigens – has the potential to address cancers in which monotherapy checkpoint inhibition may not be possible, and we are happy to further explore how we can best serve patients in need of new therapies.”