Can-Fite BioPharma Ltd. announced on Wednesday that its Phase 2a study of Namodenoson in advanced pancreatic ductal adenocarcinoma met its primary safety endpoint, with updated follow-up data showing durable overall survival in a subset of heavily pretreated patients. The findings support advancing the drug into a Phase 2b study combining Namodenoson with chemotherapy.

The open-label trial enrolled 20 patients whose disease had progressed after standard therapies. Fourteen received Namodenoson as third-line treatment, five as second-line therapy, and one as a fourth-line treatment. The company stated that Namodenoson was well tolerated, with a safety profile consistent with previous clinical studies.

Survival Analysis in Third-Line Cohort

Following an extended follow-up period, the company conducted an updated survival analysis in the third-line cohort. The analysis focused on eight patients who survived at least two months after starting treatment, excluding those with rapidly progressive disease who were considered unlikely to benefit from systemic therapy.

Among these eight evaluable patients, the median overall survival exceeded five months. The company reported that 62.5% of patients survived at least 5 months, while 37.5% survived at least 7 months. Two patients were still alive at the data cutoff, with one continuing to receive Namodenoson treatment and another followed for nearly nine months. The company also noted durable disease control, including progression-free survival extending beyond seven months.

Plans for Phase 2b Combination Study

Based on the updated results and discussions with the study's principal investigator, Can-Fite plans to advance Namodenoson into a Phase 2b study combining the drug with chemotherapy. The company said the decision was supported by recently published peer-reviewed preclinical data showing Namodenoson enhanced the anti-tumor activity of chemotherapeutic agents in pancreatic cancer models. The drug works by inhibiting multiple tumor proliferation and drug-resistance pathways while increasing cancer-cell sensitivity to chemotherapy.

The company also highlighted that among the five second-line patients, one remained alive more than 18 months after initiating Namodenoson, making that patient the longest survivor in the study.

Can-Fite BioPharma Ltd. saw its shares rise 13.6% to $3.34 on Friday after securing a patent allowance from the Japan Patent Office for its lead drug candidate Namodenoson. The patent, Application No. 2025-049941, covers the use of A3 adenosine receptor agonists for treating obesity and related metabolic disorders. This development strengthens the company's intellectual property protection in a major pharmaceutical market and supports its strategy for global exclusivity.

The allowed patent is a divisional application of JP 2023-078136 and is titled "An A3 Adenosine Receptor Ligand for Use for Achieving a Fat Loss Effect." Can-Fite has already secured patent protection for this technology in the United States, Canada, Australia, and Israel. The company cited peer-reviewed research in the International Journal of Obesity validating Namodenoson's mechanism of action.

Namodenoson is an orally administered, highly selective A3 adenosine receptor agonist with an established safety profile from clinical studies. Preclinical and clinical findings suggest its potential to reduce fat accumulation while improving metabolic parameters. The drug is also being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded a successful Phase 2a study in pancreatic cancer, and is enrolling patients for a Phase 2b trial in Metabolic Dysfunction-associated Steatohepatitis (MASH).

Dr. Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite, emphasized the importance of this milestone. "The allowance of this patent in Japan significantly strengthens our global intellectual property portfolio in one of the world's most important pharmaceutical markets," she said. "Together with our growing body of scientific evidence and established clinical safety database, this expanding patent estate enhances the value of Namodenoson as a differentiated oral therapeutic candidate for obesity and metabolic diseases and further supports future partnering opportunities."

Analysts have recently adjusted their outlook on the stock. D. Boral Capital upgraded the stock to Buy with a target of $7.00 on May 13, while HC Wainwright & Co. maintained a Buy rating and raised its target to $5.00 on May 12. The stock currently carries a Buy rating with an average price target of $6.00.

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