The Phase 1b dose-escalation stage has now been completed, encompassing six patients in the high-risk MDS cohort and six in the AML cohort, and the study is progressing into the Phase 2a part. Nadunolimab in combination with azacitidine or azacitidine and venetoclax was generally well tolerated across both patient groups, with an acceptable safety profile.

In the high-risk MDS cohort, six patients have been dosed, five of which are efficacy-evaluable. Notably, all five achieved complete remissions. The sixth patient is pending evaluation. These findings, while preliminary, suggest a promising signal of clinical activity for nadunolimab in combination with standard-of-care therapy in high-risk hematologic malignancies.

The investigator-initiated trial is led by Gautam Borthakur, M.D., Ph.D., Professor of leukemia at The University of Texas MD Anderson Cancer Center.

“We are encouraged by the early clinical responses observed in high-risk MDS patients, particularly given the high unmet medical need in this population,” said Dr Gautam Borthakur. “Although the patient number remains small, the consistency of the responses and the manageable safety profile warrant further study as we continue trial enrollment.”

“These data add to the growing body of clinical evidence supporting nadunolimab across our oncology programs,” said Hilde Steineger, CEO of Cantargia. “Although based on a limited number of patients, the complete remission rate observed to date is encouraging and consistent with our understanding of IL1RAP targeting in combination with standard therapies.”

Further progress updates from the ongoing trial are expected later in 2026. The study will include approximately 40 patients in total. For details about the study [NCT06548230], reference is made to clinicaltrials.gov.