Cantargia AB today announced that the first patient has started treatment with nadunolimab (CAN04) and chemotherapy in the phase I/II clinical trial CESTAFOUR. This trial evaluates CAN04 in combination with standard of care chemotherapy in three different forms of cancer: biliary tract cancer (BTC), colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) and is planned to include up to a total of 165 patients.

Cantargia AB today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion for orphan designation of nadunolimab (CAN04) for treatment of pancreatic cancer. The European Commission is now expected to grant the orphan designation. This provides a range of incentives in the continued clinical development of CAN04 in pancreatic cancer.

Cantargia AB today announced that the clinical trial application for the phase Ib/II clinical study TRIFOUR has received approval by the regulatory authority and ethics committee in Spain. This study broadens Cantargia's clinical program to include triple negative breast cancer (TNBC) and will investigate nadunolimab (CAN04) in combination with chemotherapy in up to approximately 120 patients with TNBC. The first patient is expected to be enrolled in November 2021.

Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer. This provides access to various incentives in the continued clinical development of nadunolimab in pancreatic cancer.