Can-Fite Reports Positive Final Phase IIa Data for Namodenoson in Advanced Pancreatic Cancer

RAMAT GAN, Israel — October 26, 2026

Phase IIa Study Demonstrates Favorable Preliminary Safety Findings

The Phase IIa study evaluated namodenoson in patients with advanced pancreatic ductal adenocarcinoma who had received previous systemic therapies. Pancreatic cancer remains a challenging disease, particularly in advanced stages when treatment options may be limited and patients have progressed through multiple lines of therapy. The study’s primary safety endpoint was achieved, with only five adverse events in three participants considered related or possibly related to namodenoson. All reported treatment-related events were mild to moderate in severity, classified as Grade 1–2. None required a dose adjustment, interruption of treatment or discontinuation. The company also reported no Grade 3 or higher treatment-related adverse events and no treatment-related serious adverse events. These findings support the preliminary tolerability of oral namodenoson at 25 mg twice daily in this small patient population. Nevertheless, the study included only 20 participants and was not designed to establish comparative safety against another treatment. A larger study would be needed to characterize less common adverse events and determine whether the safety profile remains consistent across a broader population. The absence of severe treatment-related events in this study is encouraging, but it should not be interpreted as evidence that serious toxicity cannot occur. Safety findings must also be considered alongside clinical activity, including whether treatment produces sustained disease control or meaningful improvements in patient outcomes. The Phase IIa results provide an initial basis for continued investigation, while additional clinical evidence will be necessary to establish the overall benefit-risk profile of namodenoson in pancreatic cancer.

Exploratory Survival Outcomes Highlight Potential Clinical Activity

The study’s exploratory efficacy findings included survival outcomes from a subgroup of patients receiving namodenoson in the third-line setting. Among eight third-line patients who survived beyond two months, median OS was 6.28 months and median PFS was 2.27 months. The analysis was conducted post hoc and focused on patients who survived beyond the two-month threshold to allow sufficient treatment exposure for evaluation. This selection criterion is an important limitation because survival-based subgroup selection can introduce bias and may make outcomes appear more favorable than those observed in an unselected patient population. The study was also open-label and lacked a randomized control group, preventing direct comparison with standard therapies or determination of the treatment’s effect on survival. Separately, one patient treated in the second-line setting achieved a PFS of 16.39 months and an OS exceeding 20.7 months as of September 23, 2026. This individual outcome is notable but cannot establish a typical treatment response or predict results in other patients. Individual patient experiences can differ substantially according to disease biology, prior treatment, baseline health and other clinical factors. Taken together, the findings provide a preliminary signal that warrants further investigation rather than definitive evidence of efficacy. A larger, appropriately controlled clinical study would be needed to determine whether namodenoson improves progression-free or overall survival, identify the patients most likely to benefit and assess whether the observed outcomes can be reproduced. The distinction between a promising exploratory result and a proven clinical benefit remains particularly important in advanced pancreatic cancer.

Namodenoson Mechanism and Clinical Development Program

Namodenoson is an orally administered, small-molecule agonist of the A₃ adenosine receptor (A₃AR), which is reported to be highly expressed in certain tumor and inflammatory cells. Its proposed mechanism involves modulation of growth-regulatory signaling pathways, including Wnt/β-catenin and RAS-associated signaling, and promotion of tumor-cell apoptosis. The candidate is designed to influence disease-associated cellular pathways while potentially limiting effects on normal cells through differential receptor expression. However, the clinical significance of these proposed mechanisms in pancreatic cancer requires further validation through clinical studies. Beyond pancreatic cancer, Can-Fite is evaluating namodenoson in a pivotal Phase III program for advanced hepatocellular carcinoma and a Phase IIb study for metabolic dysfunction-associated steatohepatitis (MASH). The company has also reported orphan drug designation for namodenoson in the United States and Europe, as well as U.S. FDA Fast Track designation for second-line hepatocellular carcinoma. These regulatory designations relate to the relevant development programs and do not constitute approval for treating pancreatic cancer. The final Phase IIa findings presented at ESMO 2026 add to the candidate’s clinical development data, particularly regarding tolerability in heavily pretreated patients. The next important step will be to establish whether the exploratory survival findings translate into reproducible clinical benefit in a larger study. Until comparative efficacy and a favorable overall benefit-risk profile are demonstrated, namodenoson remains investigational for advanced pancreatic cancer.

Source:Can-Fite BioPharma,Press release