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Can-Fite files patent application to treat Cytokine release syndrome

Monday, September 18, 2017

Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, has filed a patent application to protect the use of its drugs and other ligands which target the A3 adenosine receptor (A3AR) to treat cytokine release syndrome (CRS).

“CAR-T and other cancer immunotherapies are a very promising category of drugs and may shape the treatment of cancer in the future. When they work, they can save lives, however, a concern that needs to be addressed with this class of treatment is the relatively high incidence of CRS, a side effect which can kill patients. We believe our drugs, which bind to A3AR, have the potential to treat CRS, which could make CAR-T and other immuno-oncology drugs safer for patients,” stated Dr. Pnina Fishman, Can-Fite’s CEO. “A safe and effective treatment for CRS that does not inhibit the efficacy of CAR-T and other immuno-oncology therapies meets a growing unmet medical need in the treatment of cancer.”

CAR-T cell therapies are designed to treat certain cancers by modifying an individual patient’s own immune cells to specifically target their cancer cells. CRS, which is caused by an overactive immune response to the treatment, has been identified as a potentially severe and life-threatening side effect of CAR-T cell therapies.

While most people with CRS experience mild or moderate flu-like symptoms which are easily managed, some patients experience more severe symptoms that may lead to potentially life-threatening complications such as cardiac dysfunction, acute respiratory distress syndrome or multi-organ failure. One recently approved CAR-T therapy shows 79% of patients receiving the treatment got CRS and 49% got severe CRS, according to the drug’s prescribing information.*

Can Fite’s platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation by reducing elevated levels of pro-inflammatory cytokines such as IL-6, IL-1β, NF-Kβ, TNF-α, and more. As such, the Company believes that A3AR targeting may serve as an important treatment option for patients in reducing the risk of CRS without limiting the utility of the underlying cancer immunotherapy.

Current treatment for CRS includes aggressive immunosuppression through the use of high doses of corticosteroids to reverse the syndrome. However, while corticosteroids may control some of these toxicities, their potential to block T-cell activation and negate the clinical benefit of CART-T is a concern (Maude SL, et al, Cancer J, 2014). ACTERMA (tocilizumab), in August 2017 became the first FDA approved treatment for severe CRS induced by CAR-T, however it can mediate the immunosuppressive effect which could limit the efficacy of the immunotherapy (Lee et al, Blood, 2014).

In addition to CAR-T, CRS is also associated with therapeutic monoclonal antibody (mAb) infusions, most notably anti-CD3 (OKT3), anti-CD52 (alemtuzumab), anti-CD20 (rituximab), and the CD28 super-agonist, TGN1412.

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