Announcement • Jul 14
Can-Fite Biopharma Secures Australian Patent Allowance Supporting Namodenoson Development and Marketing in Liver and Pancreatic Cancer Can-Fite BioPharma Ltd. announced that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer." The patent complements Can-Fite's rapidly advancing oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the Company recently completed a Phase 2a clinical study demonstrating an excellent safety profile together with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine. Namodenoson selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and cancer cells. Activation of A3AR has been shown to induce apoptosis of tumor cells while sparing normal tissues, contributing to the compound's favorable safety profile demonstrated across clinical studies. 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 enroll patients for 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 of the 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. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • Jul 06
Can-Fite Biopharma Completes Patient Enrollment for Interim Analysis in Pivotal Phase 3 Psoriasis Study Can-Fite BioPharma Ltd. announced completion of enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Fourth Quarter 2026/First Quarter 2027. The study is a randomized, double-blind, placebo-controlled Phase 3 trial aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. Patients are treated with 3 mg Piclidenoson tablets or placebo administered orally twice daily. The co-primary efficacy objectives of this study are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of 75% or greater (PASI 75) and the proportion of subjects who achieve a Static Physician's Global Assessment (sPGA) at of 0 or 1 at Week 16. Piclidenoson is a first-in-class oral A3 adenosine receptor (A3AR) agonist with a differentiated mechanism of action targeting key inflammatory pathways implicated in psoriasis. Unlike injectable biologic therapies, Piclidenoson is administered orally as a tablet and has demonstrated a favourable safety profile in more than 1,500 subjects treated across clinical studies, supporting its potential use as a chronic long-term treatment. The global psoriasis therapeutics market continues to expand, driven by increasing disease prevalence and demand for safe, effective, and convenient long-term treatment options. Piclidenoson is an orally bioavailable, highly selective A3 adenosine receptor agonist with anti-inflammatory activity demonstrated in both preclinical and clinical studies. The drug has accumulated an extensive clinical safety database involving more than 1,500 subjects and is being developed as a potential chronic therapy for psoriasis and other inflammatory diseases. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. Announcement • Jul 02
Can-Fite Phase 2a Pancreatic Cancer Study with Namodenoson Achieves Primary Safety Endpoint and Demonstrates Durable Survival Outcomes in Advanced Disease Can-Fite BioPharma Ltd. 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. 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. Can-Fite BioPharma 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/ß-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. 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. 
