Bavarian Nordic A/S (CPH: BAVA), a fully integrated biotechnology company, announced on Thursday 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).

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

This phase 2 randomised trial will enrol up to 74 patients with oligometastatic, microsatellite stable mCRC eligible for complete resection. 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. 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 Programme at Rutgers Cancer Institute in New Jersey.

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. CV301 is a poxvirus-based prime/boost vaccine that incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.

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