Can-Fite BioPharma, an Israeli clinical-stage biopharmaceutical company with fully integrated pharmaceutical discovery and clinical development capabilities, develops small molecule therapeutic products for the treatment of autoimmune-inflammatory, oncological, liver diseases as well as sexual dysfunction. The company platform technology utilizes the Gi protein associated A3 adenosine receptor (A3AR) as a therapeutic target. A3AR is highly expressed in inflammatory, cancer and other pathological body cells, whereas low expression is found in normal cells, suggesting that the receptor could be a unique target for pharmacological intervention. Can-Fite BioPharma was founded in 1994 and is headquartered in Petah Tikva, Israel. It is listed on the Tel Aviv Stock Exchange (TASE: CFBI) and the New York Stock Exchange (NYSE: CANF).
CF101 (Piclidenoson) is a small molecule compound, it de-regulates signal transduction of the NF-κB by inducing A3AR activation which can resulting in apoptosis of inflammatory cells and attenuation of inflammatory responses.
In June 2022, Can-Fite Biopharma announced positive top-line results from the phase III study of CF101 in moderate to severe psoriasis overseas. The trial met its primary endpoint with statistically significant improvement and Cf101 had deman excellent safety profile.
There are more than 6.5 million people suffering from psoriasis in China with an incidence rate of 0.47%, where about 30% are with moderate-to-severe psoriasis. CF101 is expected to be a basic first-line treatment medicine for psoriasis.
CF102 (Namodenoson) is a small molecule compound. Its mechanism of action is mediated via de-regulation of the NF-κB and the Wnt signal transduction, resulting in apoptosis of tumor cells; and conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate (PI3K) which confers three downstream signal transduction pathways, the Wnt, NF-κB and α-SMA, altogether, controlling liver inflammation, fibrosis and steatosis. 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 product. CF102 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. FDA.
In April 2020, the Group’s partner Can-Fite BioPharma announced that CF102 achieved positive top-line results in the phase II study for NAFLD/NASH: meeting the efficacy endpoints and continuing to demonstrate good safety.
Primary liver cancer is currently the fourth most common malignant tumor in China and the third leading cause of death by cancer, among which, HCC accounts for 85% to more than 90%. NAFLD is the most common chronic liver disease worldwide, and the spectrum of NAFLD diseases includes non-alcoholic hepatic steatosis, NASH, etc. The prevalence of NAFLD in ordinary adults ranges from 6.3% to 45%, with 10% to 30% of cases being NASH. The prevalence of NAFLD in most Asian countries including China is at the middle-to-upper level (>25%), which has overtaken developed countries in Europe and the U.S. and become a new challenge in the field of liver disease and metabolism in China. Once proven in rigorous clinical trials, CF102 will provide a new treatment option for patients.
