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.
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, Syndax said.
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.
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 US, Europe, Argentina, Venezuela, Taiwan, Kuwait and Saudi Arabia.
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.