The company announced last month that a request for a pre-IND meeting with the US FDA has been submitted.
The purpose of the meeting is to discuss the current documentation on the antibody CAN04 and a proposed new phase I clinical combination study with CAN04 and an immune checkpoint inhibitor under a US IND. The plan is to conduct this trial at clinical centers in the US.
Abou the CANFOUR trial
CAN04 is investigated in an European open label three-armed phase I/IIa clinical trial, CANFOUR, examining monotherapy as well as combination with two different standard chemotherapy regimes in patients with non-small cell lung cancer or pancreatic cancer.
The new proposed clinical trial
The new proposed clinical trial will investigate CAN04 in combination with an immune checkpoint inhibitor. The design has been developed in collaboration with experts in the field, states the company. The purpose of the trial is primarily to investigate safety of the combination therapy in a few selected IL1RAP expressing cancer forms which are currently being treated with immune checkpoint inhibitors. Besides safety, biomarkers and efficacy will also be studied. A more detailed design will be presented after potential input from the US FDA.
“We are excited to advance the development of CAN04 into combination with other immune therapies as well as initiate discussions with the US FDA. These are two important steps forward for Cantargia,” says Göran Forsberg, Cantargia’s CEO.