On August 15, 2018 Bavarian Nordic reported the signature of a drug supply agreement with Bristol-Myers Squibb (Press release, Bavarian Nordic, AUG 15, 2016, View Source [SID1234527669]). Based on the agreement, BMS will supply OPDIVO (nivolumab) to Bavarian Nordic for use in a clinical study. The trial, which will be sponsored by Bavarian Nordic, will enroll approximately 160 patients and will look to explore the benefit of combining CV301 with OPDIVO in patients with previously treated non-small cell lung cancer (NSCLC). OPDIVO is approved for treatment of patients with NSCLC in the second line setting, among other indications.
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CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types, including lung, bladder and colorectal cancer. Similar to PROSTVAC, CV301 uses an off-the-shelf, prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.
Preclinical data shows the ability of CV301 to 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.
"We are extremely excited to announce this agreement between Bavarian Nordic and BMS. While we have discussed the potential benefit of combining our cancer vaccines with checkpoint inhibitors for some time, this is now within reach as we have once again been able to strike an agreement with the leading immune-oncology company in the world, this time to explore the potential synergy between our programs to benefit patients with lung cancer. We look forward to the initiation of this study later this year," stated Paul Chaplin, President and CEO of Bavarian Nordic.
Bavarian Nordic continues to retain all commercial rights for CV301. There is no obligation on behalf of BMS, beyond the contribution of drug material.