Israel-based Can-Fite BioPharma (NYSE American: CANF) reported Phase IIa data for namodenoson in advanced pancreatic adenocarcinoma showing stable disease in more than 30% of evaluable patients, with 35% remaining on therapy — including one patient beyond 16 months — in a heavily pretreated population where durable disease control is rarely observed with available agents.
The Phase IIa study is an open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease progressed on at least one prior line of therapy, or who declined standard treatment. Twenty evaluable patients were enrolled.
The trial's primary endpoint was safety, which the company said was met: namodenoson was well tolerated, with no new safety signals identified and a profile consistent with prior clinical experience across other oncology indications. The secondary objectives — including objective response rate by RECIST 1.1, progression-free survival, disease control rate, duration of response, and overall survival — remain under analysis, as a meaningful proportion of patients are still on treatment. Full efficacy data, including PFS and OS readouts, are expected in the coming months and will be presented at a clinical conference. Cross-trial comparisons are limited by differences in patient populations, treatment lines, and study designs.
The 35% on-therapy rate and the single patient exceeding 16 months on treatment are notable in a disease setting where median overall survival with standard first-line regimens such as FOLFIRINOX or gemcitabine plus nab-paclitaxel typically ranges from roughly eight to twelve months, and where second-line options offer limited durability. That said, the dataset is small — 20 evaluable patients in an open-label, single-arm design — and no formal efficacy conclusions can be drawn until the full analysis is complete.
Namodenoson is a selective agonist of the adenosine A3 receptor (A3AR), a G protein-coupled receptor that is overexpressed on tumor cells relative to normal tissue. Activation of A3AR is proposed to trigger downstream deregulation of Wnt/β-catenin and NF-κB signaling, leading to upregulation of GSK-3β, suppression of cyclin D1, and induction of apoptosis in cancer cells. The mechanism is entirely distinct from all currently approved therapies in pancreatic adenocarcinoma, none of which target the adenosine receptor axis. Namodenoson is administered orally at 25 mg twice daily in 28-day cycles — a route of administration that contrasts with the IV-based backbone regimens that dominate current standard of care.