Immunotherapy candidate for multiple cancers


CV301 is an active immunotherapy candidate that targets two tumor-associated antigens, CEA and MUC-1, long known to be overexpressed in most solid tumors. Preclinical data shows that antigen specific vaccination results in T cell infiltration into areas of antigen expression and upregulation of PD-L1 on antigen expressing tumor cells. 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. 

CV301 is in the unique position to potentially demonstrate a broad proof of concept not only in settings where checkpoints have set a new standard of survival, but also in cancers, such as micro-satellite stable colorectal, where checkpoint inhibitors have yet to demonstrate single-agent activity and may require combinations with other agents. The CV301 strategy has been adapted during 2018 focusing our resources on smaller studies, some with adaptive designs, where there remain options to demonstrate rapid proof of concept of the combination with checkpoint inhibition.

Ongoing or planned trials

Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Location: USA
Read more: NCT03628716
Phase 2 Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Resectable Hepatic-Limited Metastatic Colorectal Cancer
Location: USA
Read more: NCT03547999
A Phase 1/2 Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma
Location: USA
Read more: NCT03376659