On July 11, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported 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) (Press release, Bavarian Nordic, JUL 11, 2018, View Source [SID1234527657]).
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Bavarian Nordic’s CV301 is designed to create a T-cell response against the tumor antigens CEA and MUC1, which are overexpressed on multiple solid tumors, 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.
The randomized, 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 Program at Rutgers Cancer Institute, with material support from Bavarian Nordic and Bristol Myers Squibb. The study is expected to enroll 78 patients. 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. Overall survival (OS) and several secondary measures will be evaluated in each arm.
"We are thrilled to see the first dose administered in this trial to evaluate the combination therapy of CV301 and nivolumab in patients with resectable, oligometastatic, microsatellite stable colorectal cancer (MSS)," said Paul Chaplin, President and CEO of Bavarian Nordic. "While checkpoint inhibitors have been impressive in some tumors, there are hundreds of thousands of cancer patients in dire need of new treatments, particularly in MSS. We are eager to explore how CV301 enhances the overall survival and lowers the risk of reoccurrence in these patients."
For more information on how to take part in this trial, individuals should call Rutgers Cancer Institute’s Office of Human Research Services at 732-235-8675 or e-mail [email protected].
About CV301
CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI). CV301 targets two tumor-associated antigens, CEA and MUC1, which are over-expressed in multiple solid tumors, 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.
Preclinical data shows that MVA-BN vaccines encoding a tumor antigen transgene (like CEA and MUC-1) upregulate PD-L1 by mounting an immune response against a tumor target. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.