LUND, SE / ACCESS Newswire / April 27, 2026 / Cantargia AB (Nasdaq Stockholm:CANTA), a clinical-stage biotechnology company focused on antibody-based therapeutics targeting IL1RAP, today announced early results from the ongoing Phase 1b/2a clinical trial evaluating nadunolimab in combination with azacitidine in high-risk myelodysplastic syndrome (MDS), or in combination with azacitidine and venetoclax in patients with acute myelogenous leukemia (AML).
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.
For further information, please contact
Hilde Steineger, CEO
Telephone: +46 (0)46-275 62 60
E-mail: info@cantargia.com
About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia’s oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed.
Cantargia is listed on Nasdaq Stockholm (ticker:CANTA). More information about Cantargia is available at www.cantargia.com.
About nadunolimab (CAN04)
Nadunolimab is an antibody that binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and the development of resistance to chemotherapy. Nadunolimab has been investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316, evaluated nadunolimab in combination with standard chemotherapies in patients with pancreatic ductal adenocarcinoma (PDAC) (gemcitabine/nab-paclitaxel) or non-small cell lung cancer (NSCLC) (platinum-based chemotherapies). Positive data show durable responses for combination therapy in 73 PDAC patients, resulting in a median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Intriguing efficacy was observed in a small group of non-squamous NSCLC patients post PD(L)-1 therapy.
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Cantargia Announces Early Results from Trial of nadunolimab in MDS and AML
SOURCE: Cantargia
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