Swedish biotechnology company Cantargia AB (STO:CANTA) said on Monday that it has been awarded a USD1.1m grant from the US Department of Defense to fund a phase Ib/IIa clinical trial of its lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in patients diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

This trial will investigate nadunolimab as a standalone treatment or in combination with chemotherapy azacytidine for intermediate or high-risk MDS patients. Additionally, it will assess nadunolimab in combination with azacytidine and the targeted therapy drug venetoclax for patients with relapsed/refractory AML.

The primary objective is to evaluate the safety and dosage levels of nadunolimab, with secondary objectives including early efficacy and biomarker assessments. The trial may include up to 40 patients.

IL1RAP (Interleukin-1 Receptor Accessory Protein), the target of nadunolimab, was initially identified as a promising therapeutic target on leukaemia stem cells at Lund University, Sweden. Preclinical models have demonstrated significant therapeutic effects of IL1RAP-targeting antibodies. Nadunolimab has also shown clinical activity signals in combination with chemotherapy for various cancers, including pancreatic cancer, triple-negative breast cancer and non-small cell lung cancer, with ongoing clinical trials in these disease areas.

AML, a highly lethal form of leukaemia originating from immature bone marrow cells, is the most prevalent type of acute leukaemia in adults. Meanwhile, MDS represents a group of cancers affecting bone marrow stem cells, with high-risk MDS patients facing an increased risk of progressing to AML.