WALTHAM, Mass., June 2, 2011 /PRNewswire/ — Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, today announced allowance by the United States Patent and Trademark Office of Patent Application Serial No. 12/549458 entitled: ” N-(2-AMINOPHENYL)-4[N-(PYRIDINE-3-YL)- METHOXYCARBONYL—AMINOMETHYL]-BENZAMINE (MS-275) POLYMORPH B.” This follows the UK issuance which was granted in October of 2010 adding to the extensive patent estate.
The patent covers the novel polymorph form B of the oral histone deacetylase inhibitor, entinostat, being developed by Syndax for combination therapy with aromatase inhibitors for metastatic breast cancer and erlotinib for advanced non-small cell lung cancer.
“This U.S. allowance comes at a strategic time for Syndax and the development of entinostat since we now have the results of our randomized Phase 2 placebo-controlled study in metastatic breast cancer in hand and we are advancing entinostat in to Phase 3 studies,” said Joanna Horobin, president and chief executive officer of Syndax. ” We believe entinostat may help address the significant need to improve outcomes for the thousands of women in the United States living with metastatic breast cancer by extending the benefit of hormone therapy and delaying initiation of chemotherapy. With patent life extending through 2029, we are looking forward to maximizing the opportunities to develop entinostat in multiple indications.”
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 was tested in patients with advanced breast cancer in combination with aromatase inhibitors in a randomized, placebo-controlled phase 2 trial. The results will be presented at a scientific conference later this year and the Company is planning to move into pivotal trials at the beginning of next year. In December 2010, results were presented from a randomized, placebo controlled Phase 2 study showing a four-month survival advantage when entinostat was added to erlotinib in a subset of patients with non-small cell lung cancers expressing high levels of E-cadherin. Syndax also has several studies of entinostat ongoing under a cooperative research and development agreement with the National Cancer Institute including trials in combination with azacitidine in patients with advanced non-small cell lung cancer and advanced colorectal cancer.
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 has worldwide rights to develop and commercialize entinostat 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.