“Besides the exciting results generated with nadunolimab in patients with solid tumors, the prestigious grant from the DOD validates the additional potential in leukemia. We are really excited to start treating patients within a few months and look forward to this important clinical trial” said Göran Forsberg, CEO of Cantargia.

Nadunolimab has been investigated to date by Cantargia in approximately 300 patients with solid tumor indications and has shown clear signals of clinical activity. Right now, a controlled phase II clinical trial in triple negative breast cancer is ongoing and a new phase IIb trial investigating two dose levels of nadunolimab and one control group in first line treatment of metastatic pancreatic cancer is currently in the start-up phase.

In the context of cancer, IL1RAP was initially discovered as a therapeutic target in leukemia. Preclinical and translational results on IL-1 biology in various forms of leukemia as well as an overexpression of IL1RAP on both leukemia cells and leukemic stem cells indicate that nadunolimab has the potential to be used in the treatment of several different forms of the disease.

The new phase Ib/IIa clinical trial is designed to investigate nadunolimab monotherapy as well as combination therapy, in up to 20 patients with AML and 20 with MDS. In addition to investigating anticancer effects, the study will include an extensive package of biomarker assessments using blood and bone marrow samples, including single cell multimodal analysis. The trial is sponsored by a grant from the DOD to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial, with Dr Gautam Borthakur as principal investigator. More details on the trial will be disclosed once the trial has received regulatory approval from the US FDA and relevant IRB.