Cantargia Announces Advances in DOD-Funded Leukemia Clinical Trial for Nadunolimab

Cantargia, a biotech firm listed on the Nasdaq Stockholm exchange, has announced advancements in a clinical trial for nadunolimab, a drug under investigation for use in treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The study, set to include up to 40 patients, is backed by a US Department of Defense (DOD) grant and is anticipated to begin in the summer of 2024, subject to approval by the US Food and Drug Administration (FDA).
Göran Forsberg, Cantargia's CEO, expressed enthusiasm for the potential of nadunolimab, noting its promising results in solid tumor patients and the significance of the DOD's financial support. The company has previously tested nadunolimab in nearly 300 solid tumor patients, with indications of clinical effectiveness. Currently, a phase II trial for triple negative breast cancer is underway, and a phase IIb trial for metastatic pancreatic cancer is in its initial stages.
IL1RAP, a protein linked to various forms of cancer and inflammatory diseases, is targeted by nadunolimab. Preclinical findings suggest that the drug could be effective against several types of leukemia, given the overexpression of IL1RAP in these conditions. The upcoming phase Ib/IIa trial will assess both monotherapy and combination therapy with nadunolimab in AML and MDS patients, incorporating a comprehensive biomarker analysis using blood and bone marrow samples.
The University of Texas MD Anderson Cancer Center, funded by the DOD, will conduct the trial under the leadership of Dr. Gautam Borthakur. Further details will be provided once regulatory approval is obtained from the FDA and the Institutional Review Board (IRB).
Cantargia focuses on developing antibody-based treatments for severe diseases, with its main program, the antibody nadunolimab (CAN04), being evaluated in combination with chemotherapy, particularly for pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer. The company's second program involves the antibody CAN10, which targets autoimmune and inflammatory diseases, with an initial focus on systemic sclerosis and myocarditis.
Nadunolimab operates by binding to IL1RAP, triggering antibody-dependent cellular cytotoxicity (ADCC) and blocking IL-1 signaling pathways, thus countering the immune-suppressive tumor microenvironment and resistance to chemotherapy. The drug is currently being tested in several clinical trials, with positive interim data showing significant responses and survival benefits in specific cancer patient groups.

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