Press release

Sep 18, 2023  ·  Regulatory information

Cantargia announces new nadunolimab clinical trial in leukemia financed by external US grant

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced award of a $1.1 million grant from the US Department of Defense for investigation of Cantargia’s lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in a phase Ib/IIa clinical trial in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The grant is awarded to Professor Gautam Borthakur at The University of Texas MD Anderson Cancer Center who will lead the trial.

“We are very grateful for the important financial support from the US Department of Defense, as this grant will provide a valuable opportunity for Cantargia to expand its promising clinical results for nadunolimab to hematological cancers,” said Göran Forsberg, CEO of Cantargia.

The trial will investigate nadunolimab alone or in combination with the chemotherapy azacytidine in patients with intermediate or high-risk MDS. Nadunolimab will also be evaluated with azacytidine and the targeted therapy drug venetoclax in patients with relapsed/refractory AML. The primary objective of this investigator-initiated trial is to assess the safety of different dose levels of nadunolimab; early efficacy and various biomarkers will be evaluated as secondary objectives. The trial may include a total of 40 patients. The trial will be managed by MD Anderson who will submit a clinical trial application.

IL1RAP (Interleukin-1 Receptor Accessory Protein), the target of nadunolimab, was originally discovered as a promising therapeutic target on leukemia stem cells by Dr. Marcus Järås and Dr. Thoas Fioretos and at Lund University, Sweden. The group has published strong therapeutic effects of IL1RAP-targeting antibodies in several advanced preclinical models of leukemia. Nadunolimab has also shown signals of clinical activity in combination with chemotherapy in pancreatic cancer, triple-negative breast cancer and non-small cell lung cancer, and clinical trials are ongoing in these diseases.

“Having documented the presence of IL1RAP on leukemia stem cells and strong anti-leukemia activity by nadunolimab in multiple preclinical models, I believe this upcoming clinical trial constitutes crucial progress towards our goal to provide new treatment options for patients with a very high unmet medical need,” said Dr. Thoas Fioretos, Professor at Lund University, Sweden, co-founder and senior scientific advisor of Cantargia.

AML is a type of blood cancer, or leukemia, that originates from immature cells in the bone marrow. It is a highly lethal disorder and the most common form of acute leukemia among adults. MDS constitutes a group of cancers which impact stem cells in the bone marrow, and patients with high-risk MDS have a high risk of progressing into AML.