Ramat Gan, Israel — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced new preclinical findings demonstrating that namodenoson enhances the anti-cancer effect of gemcitabine chemotherapy in pancreatic cancer. The findings provide mechanistic support for the design of Can-Fite’s planned Phase IIb study evaluating namodenoson in combination with gemcitabine and additional standard-of-care therapy in patients with advanced pancreatic adenocarcinoma.
In pre-clinical studies the combination of namodenoson and gemcitabine increased the level of a protein, cleaved caspase-3, a central mediator of cell death (apoptosis). These findings indicate that namodenoson weakens the survival mechanisms of pancreatic cancer cells, thereby increasing their susceptibility to chemotherapy and enabling a stronger tumor cell-death response.
The new findings directly support the scientific rationale underlying Can-Fite’s planned randomized Phase IIb study in advanced pancreatic adenocarcinoma. The proposed study will evaluate namodenoson in combination with gemcitabine and additional standard-of-care therapy, Nab-paclitaxel, building upon the favorable safety profile and encouraging clinical activity observed with namodenoson monotherapy in the Company’s Phase 2a pancreatic cancer study.
“These findings provide an important mechanistic explanation for the enhanced anti-cancer effect observed when namodenoson is combined with chemotherapy,” stated Pnina Fishman, Ph.D., Can-Fite’s Chief Scientific Officer and Chairperson. “Namodenoson suppressed key survival pathways in pancreatic cancer cells and increased caspase-3-mediated apoptosis, thereby enhancing the activity of gemcitabine. These results strongly support the combination approach incorporated into the design of our planned Phase IIb study.”
Clinical results from Can-Fite’s Phase 2a study of namodenoson in advanced pancreatic adenocarcinoma have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2026.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and is enrolling patients in a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.
Contact
Can-Fite BioPharma
Motti Farbstein
[email protected]
+972-3-9241114