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 that its Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes.
The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated, with a safety profile consistent with prior clinical trials.
Following extended follow-up, an updated survival analysis was performed in the third-line population, focusing on the eight patients who survived at least two months after treatment initiation, thereby excluding patients with rapidly progressive disease unlikely to derive benefit from systemic therapy.
Among the eight evaluable third-line patients:
• Median overall survival exceeded 5 months
• 62.5% of patients survived five months or longer
• 37.5% survived seven months or longer
• Two patients remain alive at the data cutoff, including one patient continuing treatment and another followed for almost nine months
• Durable disease control was observed, including progression-free survival extending beyond seven months.
The findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy, supporting further clinical development of Namodenoson.
Notably, among the five patients treated in the second-line setting, one patient remains alive more than 18 months after initiation of Namodenoson therapy, representing the longest survivor in the study.
Prof. Salomon Stemmer, who is leading the Phase 2a study and is an oncology key opinion leader and Professor at the Davidoff Institute of Oncology, Rabin Medical Center, Israel, commented: “Pancreatic cancer remains one of the most difficult malignancies to treat, particularly after failure of standard therapies. The results of Namodenoson monotherapy are impressive and the favorable safety profile together with the prolonged survival observed in a subgroup of patients, suggest biological activity worthy of further investigation. Based on these findings and the growing preclinical evidence demonstrating enhancement of chemotherapy activity, I believe the next logical step is evaluation of Namodenoson in combination with chemotherapy.”
Based on these findings and discussions with the study’s principal investigator, Can-Fite plans to advance Namodenoson into a Phase 2b combination study with chemotherapy. The decision follows recently published peer-reviewed preclinical data demonstrating that Namodenoson (2-Cl-IB-MECA) enhances the anti-tumor activity of chemotherapeutic agents in pancreatic cancer models by simultaneously inhibiting multiple tumor proliferation and drug-resistance pathways, including Wnt/β-catenin and Hedgehog signalling, while reducing expression of multidrug-resistance proteins. The publication further demonstrated that Namodenoson increased chemosensitivity in pancreatic cancer cells, providing a strong mechanistic rationale for combination therapy
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
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+972-3-9241114