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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA