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Cantargia’s IND application for CAN04 approved by FDA

Cantargia has announced that its IND application regarding the antibody CAN04 has been approved by the US FDA.

CAN04, an antibody targeting interleukin 1 receptor accessory protein (IL1RAP), is currently being investigated for treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC) in phase IIa clinical development.

CAN04 development can now be expanded to the US with a new phase Ib clinical trial investigating CAN04 in combination with immunotherapy in selected cancer forms overexpressing IL1RAP.

The next step is a phase Ib trial

CAN04 is investigated in an open label phase I/IIa clinical trial, CANFOUR, examining two different first line chemotherapy combinations in patients with non-small cell lung cancer or pancreatic cancer, as well as monotherapy in late stage patients.

Cantargia is now in the process of broadening the development activities and the next step is a phase Ib trial investigating CAN04 in combination with the PD1 binding antibody pembrolizumab (Keytruda). The FDA has now approved the trial. Upcoming next steps before patients can start treatment include IRB approvals as well as some other administrative procedures.

Three US clinical centres

Even though the COVID-19 pandemic makes estimates complex, first patient in is planned during Q3 2020.

The trial is planned to be conducted at three US clinical centres with University of Pennsylvania being the lead centre. Up to 18 patients will be treated and the primary endpoint is safety, with biomarkers and tumor measurements being additional key parameters. Four different cancer forms overexpressing IL1RAP will be investigated i.e. NSCLC, head and neck cancer, urothelial cancer or malignant melanoma. These patients should previously have been treated with, and benefitted from, immune checkpoint therapy. The patients will start therapy at 5 mg/kg CAN04 and can receive treatment until disease progression. Additional details and updates of the trial will continuously be posted to from Q2 2020.

“Starting clinical development of CAN04 in USA is a key strategic goal for Cantargia which will lead to additional awareness. It is a strength that US FDA has reviewed our documentation and approved clinical activities in the US. The granted IND also enables future activities on regulatory designations aimed at accelerating development of promising drugs,” says Göran Forsberg, CEO of Cantargia.

Photo of Göran Forsberg: Cantargia