Cantargia AB (STO:CANTA), a biotechnology company that develops antibody-based treatments for life-threatening diseases, announced on Wednesday the submission of a request for a pre-IND meeting with the US Food and Drug Administration (FDA).

Reportedly, 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.

According to the company, the plan is to conduct this trial at clinical centres in the United States.

Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signalling.

Currently, CAN04 is being investigated in a 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.

This 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. 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 FDA, the company added.