On February 24, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has filed a patent application for its drug candidate Namodenoson to be used as a combination therapy with checkpoint inhibitors (Press release, Can-Fite BioPharma, FEB 24, 2020, View Source [SID1234554634]). Titled "Programmed Death 1/Programmed Death Ligand 1 (PD-1/PD-L1) Axis Inhibitor For Use In Combination With An A3 Adenosine Receptor (A3AR) Ligands", the patent application addresses various oncology indications including advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson is currently being developed by Can-Fite as a monotherapy for HCC, with a Phase III study expected to commence in 2020.
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Checkpoint inhibitors, including PD-1 and PD-L1 inhibitors, are a novel class of oncology drugs with a global market value of $10.6 billion in 2017 and estimated to reach $56.5 billion by 2025 according to Allied Market Research. PD-1 and PD-L1 comprise the largest category within the checkpoint inhibitor market, driven by sales of pembrolizumab and nivolumab.
Patients respond very well to checkpoint inhibitors, however a high percentage may develop resistance to the drugs. New studies show that activation of the β-catenin protein in tumor cells helps cancer to escape detection by the body’s natural immune mechanisms and creates resistance to PD-1 and PD-L1 checkpoint inhibitors, including nivolumab and pembrolizumab, two of the most broadly used checkpoint inhibitors on the market today. In pre-clinical studies, Can-Fite’s Namodenoson has shown to significantly inhibit the expression of PD-L1 in liver pathological cells, and therefore has the potential to boost the efficacy of drugs that inhibit PD-1 and PD-L1 by helping patients overcome resistance to the drug.
"The capability of Namodenoson to inhibit the β-catenin pathway in cancer cells has the potential to play a key role in the efficacy of checkpoint inhibitors and may overcome resistance. Based on its mechanism of action, Namodenoson has anti-cancer properties as a monotherapy which may support its use as a powerful combination treatment with checkpoint inhibitors currently on the market," stated Can-Fite CEO Dr. Pnina Fishman.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.