Cantargia Updates Nadunolimab Trial Timelines for Leukemia and Triple-Negative Breast Cancer

Cantargia AB, listed on Nasdaq Stockholm under the ticker CANTA, has provided updates on the clinical trials for its antibody treatment, nadunolimab. The U.S. Food and Drug Administration (FDA) has given the green light to MD Anderson Cancer Center to commence an Investigational New Drug (IND) application for a phase 1b/2a clinical trial involving nadunolimab. This trial will focus on patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), with the initiation anticipated in the fourth quarter of 2024.

In parallel, Cantargia is expecting initial findings on safety and short-term efficacy from an ongoing phase 2 clinical trial in triple-negative breast cancer (TNBC), which is conducted in collaboration with GEICAM. These results are projected for the first half of 2025.

Göran Forsberg, CEO of Cantargia, emphasized the significance of the FDA's IND approval, marking it as a crucial step in the progress of nadunolimab for leukemia treatment. He also expressed enthusiasm for the completion of the phase 2 study in TNBC and the anticipated results in 2025.

The upcoming phase 1b/2a trial will encompass up to 20 AML patients and 20 MDS patients. Funded by a grant from the U.S. Department of Defense, MD Anderson Cancer Center will oversee the trial’s execution. Further details, including more precise timelines, will be disclosed once full Institutional Review Board (IRB) approval is obtained, expected in the third quarter of 2024, paving the way for trial initiation in the fourth quarter of 2024.

The phase 2 trial for nadunolimab in TNBC is progressing, albeit with a temporary slowdown in recruitment over the summer. Approximately 100 patients are enrolled in this randomized, controlled trial. Initial outcomes on safety and efficacy are expected in the first half of 2025.

Cantargia is also set to present new clinical findings regarding nadunolimab at the European Society for Medical Oncology (ESMO) conference in Barcelona from September 13-17, 2024. Specifics of the presentation will be released when abstracts become public on September 9, 2024.

Cantargia AB specializes in developing antibody-based treatments for serious diseases. Their primary focus is on the IL1RAP protein, which plays a role in various cancers and inflammatory conditions. The company's main oncology project, the antibody nadunolimab (CAN04), is being studied mainly in combination with chemotherapy, concentrating on pancreatic cancer, non-small cell lung cancer, and TNBC. Preliminary data for these combinations have shown enhanced efficacy compared to chemotherapy alone.

In addition to nadunolimab, Cantargia is also developing CAN10, another antibody targeting IL1RAP but in a different way than nadunolimab. CAN10 is aimed at treating severe autoimmune and inflammatory diseases, particularly systemic sclerosis and myocarditis.

Nadunolimab, known for its strong binding to IL1RAP, functions by inducing antibody-dependent cellular cytotoxicity (ADCC) and blocking IL-1alpha and IL-1beta signaling pathways. This mechanism helps counteract the immune-suppressive tumor environment and combats chemotherapy resistance. Multiple clinical trials are currently investigating nadunolimab. The CANFOUR trial is evaluating it in combination with standard chemotherapies for pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC), demonstrating encouraging interim results. Additionally, nadunolimab is being tested in trials such as TRIFOUR for TNBC, CAPAFOUR, CESTAFOUR, and CIRIFOUR with chemotherapy and the checkpoint inhibitor pembrolizumab.

Cantargia's promising developments in the field of oncology and inflammatory diseases position it as a significant player in the biotech landscape, with several key milestones anticipated in the near future.