Bavarian Nordic A/S (CPH:BAVA), a fully integrated biotechnology company, announced on Wednesday that the first patient has been dosed in a phase 2 study evaluating the combination therapy of its cancer vaccine, CV301, and Bristol Myers Squibb's checkpoint inhibitor, nivolumab (OPDIVO), for the treatment of patients with resectable hepatic-limited metastatic colorectal cancer (mCRC).

Reportedly, Bavarian Nordic's CV301 is designed to create a T-cell response against the tumour antigens CEA and MUC1, which are overexpressed on multiple solid tumours, including colorectal cancers. Preclinical data supports the premise that CV301 is highly synergistic with checkpoint inhibitors and holds the potential to broaden their efficacy in cancers where monotherapy has been ineffective.

This randomised, multiple-site, phase 2 trial is being led by Darren Carpizo, M.D., Ph.D, the director of the Liver Cancer and Bile Duct Cancer Programme at Rutgers Cancer Institute, with material support from Bavarian Nordic and Bristol Myers Squibb.

This study is expected to enrol 78 patients. Prior to surgical removal of their tumours, patients will be randomised 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. Overall survival (OS) and several secondary measures will be evaluated in each arm.

CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI). CV301 targets two tumour-associated antigens, CEA and MUC1, which are over-expressed in multiple solid tumours, including lung, bladder, colorectal and pancreatic cancers.

Bavarian Nordic is focused on the development of innovative and safe therapies against cancer and infectious diseases.