Advancements in DOD-Funded Leukemia Trial for Nadunolimab

Cantargia, a Swedish biotechnology firm, has announced advancements in a forthcoming clinical trial for nadunolimab, a drug being tested on patients with acute myeloid leukemia or myelodysplastic syndrome. The trial is slated to involve up to 40 participants and is being funded by a grant from the US Department of Defense. The company plans to submit the trial for approval to the US FDA, aiming to initiate it in the summer of 2024.

Göran Forsberg, Cantargia's CEO, expressed enthusiasm for the upcoming trial, highlighting the significance of the DOD grant and the potential of nadunolimab in treating leukemia, a disease for which IL1RAP was initially identified as a therapeutic target. Cantargia has previously studied nadunolimab in nearly 300 patients with solid tumors, where it has demonstrated promising clinical activity. 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.

The phase Ib/IIa clinical trial will explore both monotherapy and combination therapy with nadunolimab in 20 AML and 20 MDS patients. The study will not only investigate the drug's anticancer effects but also include a comprehensive biomarker assessment using blood and bone marrow samples, featuring single cell multimodal analysis. The trial is being sponsored by a DOD grant to The University of Texas MD Anderson Cancer Center, which will oversee the trial under the direction of Dr. Gautam Borthakur. Further details are expected to be revealed following regulatory approval from the US FDA and the relevant Institutional Review Board.

Cantargia is focused on developing antibody-based treatments for severe diseases, with a platform centered on IL1RAP, a protein implicated in various cancers and inflammatory conditions. The company's primary program involves the antibody nadunolimab, which is being clinically studied, primarily in combination with chemotherapy, for pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer. Encouraging interim data suggests that these combinations could be more effective than chemotherapy alone.

Nadunolimab works by binding to IL1RAP, triggering antibody-dependent cell-mediated cytotoxicity and blocking IL-1 signaling, which helps counteract the immune-suppressive tumor environment and resistance to chemotherapy. The drug is currently being tested in several clinical trials, including those that combine it with standard chemotherapies for pancreatic and lung cancers, showing durable responses and improved survival rates in patients.