Policy & Regulation
Cantargia's pre-IND meeting with US FDA results in advancement of development of antibody CAN04
18 November 2019 -

Biotechnology company Cantargia AB (STO:CANTA) announced on Friday that a pre-IND meeting regarding the clinical development of antibody CAN04 was held with the US FDA.

The company said the purpose of this meeting was to discuss the available information on CAN04, including data from the first-in-human phase I trial, as well as a proposed new phase I clinical trial with CAN04 in combination with an immune checkpoint inhibitor under a US IND.

According to the company, as a result of this meeting, it is advancing the development of CAN04 and will apply for a US IND around New Year.

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

CAN04 is currently being investigated in an open label three-armed phase I/IIa clinical trial in Europe, CANFOUR, examining CAN04 combination with two different standard chemotherapy regimens in patients with advanced non-small cell lung cancer or pancreatic cancer not previously treated with chemotherapy and monotherapy in patients with late stage cancer.

Cantargia is now expanding clinical development to investigate CAN04 in combination with an immune checkpoint inhibitor. This trial is planned to be performed at major clinical centres in the US. The coordinating investigator will be Prof. Roger Cohen at University of Pennsylvania.

The purpose of this trial is primarily to investigate safety of the combination of CAN04 and an immune checkpoint inhibitor in patients with IL1RAP-expressing cancers that include non-small cell lung cancer, head and neck squamous cancer and bladder cancer. The patients in the trial will be eligible if they have progressed on prior PD1/PDL-1 antibody therapy containing regimens.

Up to 18 patients will initially be enrolled. In addition to safety, exploratory biomarkers and efficacy will also be studied. The study protocol is being finalised for a planned IND-filing in January 2020, the company added.

Cantargia develops antibody-based treatments for life-threatening diseases.