WALTHAM, Mass., Oct. 15 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, today announced the UK Intellectual Property Office allowed application GB0907347.9 entitled N-(2-aminophenyl)-4-[N-(pyridine-3-YL)-methoxycarbonyl-aminomethyl]-benzamide (MS-275) polymorph B. The patent covers the polymorph representing a preferred stable form of entinostat (SNDX-275 formerly MS-275) with key claims covering the polymorph form B and the manufacturing process by which it is derived.
This represents the first issuance for the patent application which has been filed as a Patent Cooperation Treaty (PCT) application providing a platform for additional filings worldwide including Japan, China, India, South Africa and Brazil. The patent application also has been filed in the United States, Europe, Argentina, Venezuela, Taiwan, Kuwait and Saudi Arabia.
"We are pleased that the UK Intellectual Property Office allowed the key claims that expand the intellectual property covering entinostat with expectations for a similar outcome in the other jurisdictions in which it has been filed," said Joanna Horobin, president and chief executive officer of Syndax. "Because this important patent covers the composition of the crystalline form and the manufacturing process, it provides potential for market exclusivity in all our target indications including metastatic breast and lung cancer."
Syndax holds 36 issued patents and pending patent applications related to the composition of matter, manufacturing and use of entinostat and HDAC inhibitors in combination with other drugs.
Entinostat is an orally bioavailable, highly selective, class I histone deacetylase (HDAC) inhibitor with a long half-life that allows for weekly or every-other-week dosing. Entinostat is currently being investigated in multiple phase 2 clinical studies: in advanced breast cancer in combination with aromatase inhibitors; in combination with erlotinib in metastatic lung cancer and as a single agent in Hodgkin's lymphoma. Entinostat also is being studied in advanced non-small-cell lung cancer and in advanced colorectal cancer in combination with azacitidine under a Cooperative Research and Development Agreement (CRADA) with the NCI.
Research has shown that HDACs are involved in the expression of various genes, such as the estrogen receptor, that regulate cell growth, differentiation and apoptosis. Such genes are frequently silenced in cancer cells through the over-expression of enzymes including HDACs. HDACs are therefore recognized as promising targets for cancer treatment. Further, studies have demonstrated that HDAC inhibition can significantly enhance anti-cancer activity when used in combination with a broad range of anti-cancer agents. The potential therefore exists to overcome tumor resistance to targeted agents.
Syndax Pharmaceuticals, Inc. is a Waltham, MA-based, oncology-focused pharmaceutical company. Syndax is building a portfolio of new oncology products to extend and improve the lives of patients by developing and commercializing novel cancer therapies in optimized, mechanistically driven combination regimens. Formed in 2005, the company's intellectual property is based on work from scientific founder Ronald Evans, Ph.D., recipient of the 2004 Albert Lasker Prize for Basic Medical Research, a Member of the National Academy of Sciences, a professor at the Salk Institute for Biological Studies and a Howard Hughes Medical Institute Investigator.
Syndax holds rights to entinostat from Bayer Schering Pharma and is backed by top-tier Venture Capital firms: Domain Associates, MPM Capital, Avalon, Pappas and Forward Ventures. For more information please visit www.syndax.com.
E. Blair Schoeb
Syndax Pharmaceuticals, Inc.
SOURCE Syndax Pharmaceuticals, Inc.