Taipei, Taiwan and San Diego, July. 17, 2017-- Senhwa Biosciences, Inc. announced that it has obtained the patent of invention of “Serine-Threonine Protein Kinase and PARP Modulators” (Appl. No. 2881842) granted by Canadian Intellectual Property Office (CIPO) in July, 2017. To expand the application field, Senhwa also submitted an application of two lead compounds CX-4945 and CX-5461 for a combination therapy. It will enlarge the overall patent portfolio and possess of a larger market scope.
CX-4945 is a first in class small molecule drug that inhibits protein Casein kinase 2 (CK2), which plays an important role in the DNA damage repair mechanisms of cancer cells. Due to the complex regulatory mechanisms of CK2, the threshold of technology in drug development is highly demanding. A phase I/ II study showed that CX-4945 achieved clinical benefit as a single agent CK2 inhibitor, demonstrating stable disease and extended duration on treatment in several patients. A combination of CX-4945 with the DNA damaging agents such as gemcitabine (Gemzar) plus cisplatin (Platinol) has been shown to act synergistically to improve the efficacy of anticancer treatments.
The application to file a patent of combination therapy of CX-4945 and CX-5461 is to take advantages of each compound, to strengthen the toxicity of cancer cell and also delay the relapse of cancer patients. In addition, patent portfolio is more valuable than single patent when it comes to authorization of drug products.
Currently Senhwa obtained a total of 106 granted patents worldwide including 31 invention patents of CX-4945 in the United States, Japan, China, Hong Kong, Australia and other 19 European countries, a total of 24 countries. CX-4945 has been granted Orphan Drug Designation by US FDA in cholangiocarcinoma (CCA) in December 2016. In US, orphan drug sponsor qualifies for a 7-year marketing exclusivity if firstly approved by FDA. This Orphan Drug Designation will expedite the development of CX-4945 in CCA treatment.