Can Fite Files Patent for Namodenoson to Overcome Drug Resistance to Checkpoint Inhibitors for Oncology Indications

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, today announced it has filed a patent application for its drug candidate Namodenoson to be used as a combination therapy with checkpoint inhibitors. 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.

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 ß-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 ß-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.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). 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. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

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