Swedish biotechnology company Cantargia AB (STO:CANTA) said on Wednesday that it has enrolled the first patient in its phase 1b/2a study evaluating nadunolimab in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The trial, funded by the US Department of Defense, will assess the safety and early efficacy of nadunolimab combined with standard chemotherapy in 40 patients, with full recruitment expected by 2027.
This is the first study of nadunolimab in haematological malignancies, expanding on its promising results in solid tumours. The study is led by Dr. Gautam Borthakur at The University of Texas MD Anderson Cancer Center.
Nadunolimab targets IL1RAP, a protein found on leukaemia stem cells but not on normal haematopoietic stem cells, potentially blocking leukaemia-promoting signals while directly killing tumour cells. The discovery was made by researchers at Lund University, who continue to contribute to the study.
Primary objectives include evaluating the drug's safety and determining its recommended dosage with standard chemotherapy agents azacitidine and venetoclax. Secondary objectives include measuring response rates and disease progression.
Extensive biomarker and cellular analyses will be conducted at Lund University to further understand nadunolimab's effects on leukaemic cells.
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