Fyuzhn Farma

  • Grant accepted

Company

Project/Technology Fusion Pharma has developed a small molecule drug candidate against chronic myelogenous leukemia (CML) including its drug resistant forms. The small molecule is an inhibitor of Bcr-Abl tyrosine kinase as well as its mutant forms, which confer resistance to  сurrently available therapies (first line treatment Gleevec, and second-line drugs Tasigna and Sprycel). The drug candidate has shown high activity in in vitro and in vivo models of CML including its most severe resistant forms, favorable pharmacokinetic profile and favorable preliminary safety properties. Potential activity of the developed compound in other oncologic indications, such as non-small cell lung carcinoma, hepatocellular carcinoma, gastrointestinal solid tumors, which is being studied currently, may take place due to potent inhibitory effect on such kinases as Ret, DDR, c-Kit and some others. The developed drug candidate of Fusion Pharma has the potential for global commercialization as a third-line therapy, which may be further moved into second-line as far as Tasigna and Sprycel replace Gleevec in the first line. In the Russian Federation the developed drug candidate can be registred as a second-line therapy and it has very high commercial potential because of the governmental program for the support of CML patients with innovative targeted therapies. Proven advantages of the technology over main competitors The Fusion Pharma's drug candidate is active in the pre-clinical setting (in vitro and in vivo) against all currently known mutant forms of CML, which are resistant to the first (Gleevec) and second-line (Tasigna, Sprycel) therapies. Expected advantages of the technology over main competitors The developed drug candidate has the potential of being more safe in human compared to the most potent second-line therapy Dasatinib and clinical drug candidate ponatinib due to its more focused kinase inhibition profile Current R&D Status The complete preclinical characterization of the drug candidate is underway and is planned for completion in Q3 of 2013. Intellectual Property Russian patent is about to issued in Q4 2012, PCT application was filed in Q2 2012.

Team [1]