News|Articles|March 5, 2026
Namodenoson Demonstrates Favorable Safety in Advanced PDAC
Author(s)Andrea Eleazar, MHS
Fact checked by: Sabrina Serani
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Key Takeaways
- Namodenoson targets A3AR, overexpressed in multiple tumor types, aiming for tumor-selective activity with low expression in normal tissues and potentially reduced systemic toxicity versus cytotoxic chemotherapy.
- Phase 2a PDAC data (n=20) indicate 25 mg oral dosing is well tolerated after progression on ≥1 prior systemic therapy, including high-risk disease, without emergent safety concerns.
Phase 2a data show oral namodenoson is well tolerated in heavily pretreated pancreatic cancer, with survival follow-up ongoing and FDA orphan status boosting promise.
Namodenoson (CF102), an investigational small-molecule A3 adenosine receptor (A3AR) agonist, has demonstrated favorable safety in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who have progressed following prior systemic therapies.1
Data from a phase 2a trial (NCT06387342) of the agent indicate that the study has met its primary end point of safety, showing that namodenoson was well tolerated in a heavily pretreated population. No new safety signals have been identified, and the safety profile observed thus far has been consistent with the known safety profile of the agent in other oncologic disease states.
Regarding the study’s secondary end points of efficacy, one-third of patients remain alive at the time of the data cut-off, and follow-up for progression-free survival and overall survival remains ongoing. Mature survival data are planned to be announced at future scientific meetings, according to the sponsor.
“The favorable safety profile observed in this difficult-to-treat population supports continued clinical evaluation of namodenoson,” said Salomon Stemmer, MD of Rabin Medical Center in a news release.1 “We are continuing to monitor survival outcomes as data mature.”
About Namodenoson
Namodenoson is an orally bioavailable agent with high affinity and selectivity to A3AR. This G protein-coupled receptor is significantly overexpressed in various tumor cells, including pancreatic, liver, and colon cancers, while maintaining low expression levels in normal cells.
In October 2024, the FDA granted namodenoson
The therapeutic rationale for namodenoson lies in its ability to trigger downstream signaling pathways—specifically the Wnt/β-catenin and NF-κB pathways—which induce apoptosis in cancerous cells while potentially exerting a protective effect on healthy tissue.3 This targeted approach aims to mitigate the systemic toxicity often associated with conventional cytotoxic chemotherapy and has been supported in preclinical pancreatic cancer models.
In addition to its development in pancreatic cancer, namodenoson is also being studied in advanced hepatocellular carcinoma in the ongoing phase 3 LIVERATION trial (NCT05201404). The agent also holds orphan drug designations in the US and Europe and an FDA fast track designation for this disease state in the second-line setting.
The Unmet Need in PDAC
PDAC remains one of the most lethal malignancies, with a 5-year survival rate ranging between 11% and 13%.4 For patients progressing on first-line regimens such as FOLFIRINOX or gemcitabine/nab-paclitaxel, second-line options are limited and often accompanied by significant morbidity.
The introduction of targeted therapies like namodenoson represents a shift toward precision oncology in this space. If subsequent trials confirm these phase 2a findings, namodenoson could potentially serve as an oral, low-toxicity option for a population with high unmet medical needs.
About the Phase 2a Trial
The single-center, open-label phase 2a trial is evaluating the safety, pharmacokinetics, and preliminary antitumor activity of namodenoson.5 To date, the study has enrolled 20 adult patients with advanced PDAC who had experienced disease progression following at least 1 prior line of systemic therapy, including those with high-risk disease. Enrollment for the trial is ongoing.
Here, namodenoson is administered as an oral capsule at a 25-mg dose level. Patients are regularly monitored for safety, with tumor imaging performed approximately every 2 months.
REFERENCES
1. Can-Fite’s namodenoson successfully meets primary endpoint in phase 2a pancreatic cancer study. News release. Can-Fite BioPharma. March 4, 2026. Accessed March 5, 2026. https://tinyurl.com/dj97muct
2. FDA grants orphan drug designation to Can-Fite’s namodenoson for pancreatic cancer. News release. Can-Fite BioPharma. October 9, 2024. Accessed March 5, 2026. https://tinyurl.com/59umvkb9
3. Fishman P, Bareket-Samish A, Itzhak I. Effects of namodenoson on pancreatic carcinoma: Preclinical evidence. J Clin Oncol. 2023;41(16_suppl):e15134-e15134. doi: 10.1200/jco.2023.41.16_suppl.e15134
4. Blackford AL, Canto MI, Dbouk M, et al. Pancreatic cancer surveillance and survival of high-risk individuals. JAMA Oncol. 2024;10(8):1087. doi: 10.1001/jamaoncol.2024.1930
5. Namodenoson treatment of advanced pancreatic cancer. ClinicalTrials.gov. Updated January 31, 2025. Accessed March 5, 2026. https://clinicaltrials.gov/study/NCT06387342
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