Cantargia Presents Promising Early Results with Nadunolimab in MDS and AML Ahead of ASH 2026
Cantargia Presents Promising Early Results with Nadunolimab in MDS and AML Ahead of ASH 2026
Cantargia AB (publ) (Nasdaq Stockholm: CANTA), a clinical-stage biotechnology company focused on antibody-based therapeutics targeting IL1RAP, today announced that an abstract with early results from the Phase 1b/2a trial of nadunolimab in higher-risk myelodysplastic syndromes (MDS) and adverse risk relapsed or refractory (R/R) acute myeloid leukemia (AML) has been published ahead of the American Society of Hematology (ASH) Annual Meeting. The investigator-initiated trial showed responses in 7 of 10 evaluable patients (70%) with higher-risk MDS treated with nadunolimab and azacitidine, and in 3 of 9 evaluable patients (33%) with adverse-risk R/R AML treated with nadunolimab, azacitidine and venetoclax. The Phase 2a expansion is enrolling, with updated longer-term follow-up to be presented in an oral presentation at ASH in December 2026.
“Higher-risk MDS and adverse-risk R/R AML remain among the most difficult blood cancers to treat, and outcomes with current therapies are poor,” said Hilde Steineger, CEO of Cantargia. “Seeing early responses in both diseases supports our view that IL1RAP is a relevant target in hematologic cancers as well as solid tumors, and we look forward to the updated data being presented in an oral presentation at ASH in December.”
The investigator-initiated Phase 1b/2a trial is led by Guillermo Garcia-Manero, M.D., at The University of Texas MD Anderson Cancer Center, with financial support from the U.S. Department of Defense. Nadunolimab is being evaluated in higher-risk MDS and adverse risk R/R AML, with the recommended Phase 2 dose set at 2.5 mg/kg and enrollment expected to reach approximately 40 patients.
As of the June 30 2026 data cut-off, 22 patients had been enrolled, of whom 19 had completed at least one treatment cycle and were evaluable. In higher-risk MDS (nadunolimab plus azacitidine), the cohort included four patients with TP53 mutations and five with ASXL1 and/or RUNX1/GATA2 mutations. Seven of 10 patients (70%) responded with different forms of complete remission, according to IWG 20231, including two CR, two CRh, and three CRL. Two additional patients with stable disease after the first cycle are continuing treatment.
In adverse-risk R/R AML (nadunolimab plus azacitidine and venetoclax), including three patients with MECOM rearrangement and one with a TP53 mutation, 3 of 9 patients (33%) responded, according to ELN 20172, with one CR, one CRh and one MLFS. The patient who achieved CR with partial hematologic recovery (CRh) had MECOM-rearranged AML and proceeded to stem cell transplantation, and a patient with secondary AML remains in CR.
Of the grade 3 or 4 adverse events reported, only one, an infusion-related reaction, was considered likely related to nadunolimab. The three remaining grade 3 or 4 events were considered unlikely to be related.
The abstract is available on the ASH website. Further details about the study are available at ClinicalTrials.gov (NCT06548230).
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