namodenoson (CF102) / Can-Fite, China Medical System, Chong Kun Dang, Ewopharma - LARVOL DELTA

Can-Fite’s Latest Developments of its Advanced Stage Drug Pipeline will be Presented at Noble Capital Markets 21st Annual Emerging Growth Equity Conference (GlobeNewswire) - "Mr. Farbstein will present the latest developments in Can-Fite’s advanced stage drug development pipeline including the following trials: Phase III liver cancer; Phase IIa pancreatic cancer; Phase III psoriasis; Phase IIb MASH..."

Trial status • Liver Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Pancreatic Cancer • Psoriasis

Can-Fite to Advance New Veterinary Partnership Opportunities for Namodenoson at the BioFIT 2025 Conference (GlobeNewswire) - "At BioFIT 2025, Can-Fite aims to advance a second veterinary partnership focused on Namodenoson, its Phase III anti-cancer drug candidate....During the conference, Can-Fite will hold partnering meetings with major multinational animal health companies, including Elanco Animal Health and Zoetis, to explore collaboration opportunities for bringing Namodenoson into veterinary development."

Licensing / partnership • Hepatocellular Cancer • Liver Cancer

Can-Fite: 9-Year Survival with Complete Cure in an Advanced Liver Cancer Patient Treated with Namodenoson (GlobeNewswire) - "The patient, who suffered from advanced liver cancer, was enrolled in Can-Fite’s completed Phase II study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappearance of ascites, normal liver function, and good quality of life."

Clinical • Liver Cancer

Bitopic A3 Adenosine Receptor Molecular Probes: Positive Allosteric Modulation and Noncanonical Activation. (PubMed, J Med Chem) - "Varied terminal functionalities and introduced reporter groups, as well as N1-alkylation on the core heterocycle, substantially enhanced human A3AR agonist (Cl-IB-MECA) potency and efficacy in [35S]GTPγS binding and revealed ago-PAM activity...Molecular dynamics simulations detected stable electrostatic phospholipid interactions while maintaining A3AR allosteric binding. Thus, we rationally expanded SAR of bitopic A3AR PAMs, including molecular probes."

Journal

Bitopic A3 adenosine receptor molecular probes: Positive allosteric modulation and non-canonical activation (ACS-Fall 2025) - "Terminal N-acetyl piperazine analogue MRS8435, with 9 methylenes in the chain and an N1-benzyl group to prevent A3AR orthosteric site binding, at all concentrations tested (0.1–10 µM) achieved ~300% Emax of A3AR agonist Cl-IB-MECA but lacked ago-PAM activity...Thus, we have characterized pharmacologically an expanded range of membrane-embedded A3AR PAMs, including molecular probes, by a rational design approach. This PAM series has potential for application in disease models and translation to therapeutics."

Can-Fite Reports H1 2025 Financial Results… (GlobeNewswire) - "Research and development expenses for the first half of 2025 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH."

Commercial • Hepatocellular Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Psoriasis

Pancreatic Cancer Phase 2a Study with Can-Fite’s Namodenoson Achieved Over 50% Enrollment Milestone (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that it achieved the over 50% enrollment milestone in its Phase 2a trial of Namodenoson for pancreatic cancer."

Enrollment status • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Can-Fite to Present Phase IIa Pancreatic Cancer Study Progress During Partnering Meetings at the 2025 BIO International Convention in Boston (GlobeNewswire) - "Can-Fite BioPharma Ltd...today announced that Dr. Sari Fishman, Vice President of Business Development, will present an update on the Company’s ongoing Phase IIa study in pancreatic cancer during partnering meetings at the 2025 BIO International Convention, taking place June 16–19 in Boston, MA."

P2a data • Pancreatic Adenocarcinoma

Can-Fite Has Raised $175 Million in Total to Date for the Development of Namodenoson and Piclidenoson, Advancing into Pivotal Phase 3 Trials in Liver Cancer and Psoriasis (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that, it has raised $175 million in funding to date. These funds have enabled the advancement of its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis, respectively."

Financing • Liver Cancer • Psoriasis

LIVERATION: Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis (clinicaltrials.gov) - P3 | N=471 | Recruiting | Sponsor: Can-Fite BioPharma | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Solid Tumor

Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients (Can-Fite Biopharma Press Release) - "Can-Fite BioPharma Ltd...today announced that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson....Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols."

FDA event • Pancreatic Cancer

Can-Fite to Generate $685M in Projected Future Revenues from its Partnerships (GlobeNewswire) - "Can-Fite BioPharma Ltd....today announced the completion of a comprehensive analysis of its current partnerships and the market potential for its lead drug candidates, Piclidenoson and Namodenoson upon regulatory approvals....Based on in-depth internal modeling and insights from external advisors, the Company forecasts potential substantial revenue generation over the next decade from its two drug candidates, currently in development for four key indications: psoriasis, advanced liver cancer, pancreatic cancer, and MASH, which assumes, among other things, regulatory approval and launches between 2027 and 2029, depending on the indication and territory."

Approval • Commercial • Launch • Hepatocellular Cancer • Liver Cancer • Metabolic Dysfunction-Associated Steatohepatitis • Pancreatic Cancer • Psoriasis

Can-Fite: FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient (GlobeNewswire) - "Can-Fite BioPharma Ltd...today announced that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson."

FDA event • Pancreatic Cancer

Can-Fite Innovative Publication: Namodenoson in Liver Cancer Treatment Alongside with Cardiac, Liver, and Neurological Benefits (GlobeNewswire) - "The article presents compelling preclinical and clinical data demonstrating Namodenoson’s potent anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body tissues including the liver, central nervous system, and cardiovascular system. The study highlights Namodenoson’s ability to increase adiponectin levels, a key cytokine known to drive multi-organ protective effects. Importantly, the manuscript underscores Namodenoson’s dual role as both an anti-cancer therapy and a protective agent for normal tissues, setting it apart from conventional chemotherapy and other oncology treatments with significant toxicity."

Clinical • Preclinical • Immunology • Liver Cancer

Adenosine Receptor 3 in Liver Cancer: Expression Variability, Epigenetic Modulation, and Enhanced Histone Deacetylase Inhibitor Effects. (PubMed, Gastro Hep Adv) - "This observation might help to identify patients for clinical studies. Additionally, Namodenoson's epigenetic modulating activity suggests epigenetic drugs as promising candidates for combination treatment."

Journal • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Disappearance of Decompensated Liver Cirrhosis Episodes After Treatment with Can-Fite's Namodenoson (GlobeNewswire) - P=NA | N=NA | "Can-Fite BioPharma Ltd...announced a significant clinical development: the disappearance of episodes of decompensated liver cirrhosis following treatment with Namodenoson under a compassionate use program....At 20 months into treatment, the patient reports notable improvements in symptoms related to the disease, such as fatigue and edema. Prior to starting Namodenoson, the patient had experienced an episode of esophageal variceal bleeding, but no further gastrointestinal bleeding episodes have occurred since beginning therapy. Additionally, moderate ascites that were present before treatment have gradually resolved, with the patient now off diuretics for over a year. Liver stiffness, measured repeatedly during the course of treatment, shows a mean decline compared to levels recorded before therapy began."

Clinical data • Liver Cirrhosis

CF102-222PC: Namodenoson Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Can-Fite BioPharma | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9 • CEACAM5

Mediation of the liver protective effect of the anti-cancer drug candidate namodenoson via adiponectin. (ASCO-GI 2025) - "The anti-cancer effect of namodenoson combined with its protective effects, position it as a unique drug inducing a dual effect in patients with advanced liver cancer."

Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology

US Patent Office Granted Can-Fite Namodenoson Patent for Use as anti-Obesity Drug (GlobeNewswire) - "Can-Fite BioPharma Ltd...today announced that its lead drug candidate Namodenoson was granted a patent for its use as an anti-obesity drug by the US patent office...The patent application covers methods of treating obese patients by administering Namodenoson in an oral formulation. Can-Fite has already multiple approved patents and corresponding applications in a variety of territories around the world, for different clinical applications of the drug."

Patent • Obesity

Recognition of the American Society of Clinical Oncology (ASCO) of the Liver Protective Effect of Can-Fite’s anti-Cancer Drug Namodenoson (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced that its work titled 'The Liver Protective Effect of the anti-Cancer Drug Candidate Namodenoson is Mediated via Adiponectin' will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium to take place at San Francisco & On Line, January 23-25....Can-Fite enrolls patients for its pivotal Phase III advanced liver cancer study."

Clinical data • Enrollment status • Hepatocellular Cancer

8 Years Survival with Complete Cure for a Patient with Advanced Liver Cancer Being Treated with Can-Fite’s Namodenoson Drug (GlobeNewswire) - P1/2 | N=19 | NCT00790218 | Sponsor: Can-Fite BioPharma | "Can-Fite BioPharma Ltd...announced today that a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s Phase II Liver Cancer Study has an overall survival time of 8 years with a complete response. The patient, who suffered from advanced liver cancer was enrolled in the former Can-Fite Phase II study, continue to be treated with Namodenoson, and has now an overall survival of 8 years, with disappearance of ascites, normal liver function, good quality of life and is defined as a long term complete response."

P2 data • Hepatocellular Cancer

Structural insights into the agonist selectivity of the adenosine A3 receptor. (PubMed, Nat Commun) - "Our cryo-EM analyses elucidate the A3R-Gi complexes bound to adenosine, 5'-N-ethylcarboxamidoadenosine (NECA), m6A, i6A, and namodenoson at overall resolutions of 3.27 Å (adenosine), 2.86 Å (NECA), 3.19 Å (m6A), 3.28 Å (i6A), and 3.20 Å (namodenoson), suggesting the selectivity and activation mechanism of A3R. We further conduct structure-guided engineering of m6A-insensitive A3R, which may aid future research targeting m6A and A3R, providing a molecular basis for future drug discovery."

Journal • Oncology

Can-Fite Achieves Milestone with First Patient Dosing in Pancreatic Cancer Phase IIa Clinical Trial (GlobeNewswire) - "Can-Fite BioPharma Ltd...announces the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342)....The Phase IIa study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population."

Trial status • Pancreatic Adenocarcinoma

FDA Grants Orphan Drug Designation to Can-Fite’s Namodenoson for Pancreatic Cancer (GlobeNewswire) - "Can-Fite BioPharma Ltd...announced the Company’s oncology drug candidate, Namodenoson, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the indication of pancreatic cancer, one of the most aggressive malignancies."

Orphan drug • Pancreatic Cancer

The different effects of four adenosine receptors in liver fibrosis. (PubMed, Front Pharmacol) - "Adenosine receptor agonists CCPA, CGS21680, BAY 60-6583, and namodenoson were used for A1R/A2AR/A2BR/A3R activation, respectively. Additionally, 5'-N-ethyl-carboxamidoadenosine (NECA), a metabolically stable adenosine analog, alleviated liver fibrosis and inhibited LX2 cell activity, proliferation, and migration. This study demonstrated the different roles of A1R/A2AR/A2BR/A3R during liver fibrosis development via regulating the HSC activity and proliferation."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • COL1A1