Overview

Our lead compound is entinostat (SNDX-275), an oral class I–selective HDAC inhibitor that has been evaluated in over 250 cancer patients. A long half-life (~100 hours) further differentiates entinostat (SNDX-275) from other HDAC inhibitors and allows weekly or biweekly dosing in the clinic. entinostat (SNDX-275) has shown preliminary evidence of good tolerability and in preclinical studies inhibited the growth of a range of human tumor xenografts, including models of lung cancer, prostate cancer, breast cancer, pancreatic cancer, renal cell cancer, and glioblastoma. In addition, entinostat (SNDX-275) exhibited synergism with a number of targeted therapies. In pharmacodynamic studies, entinostat (SNDX-275)-dependent histone hyperacetylation was observed at all doses tested to date, confirming HDAC inhibition in humans.

Combined, these features present a unique opportunity, with entinostat (SNDX-275) serving as a conveniently dosed "background" sensitization regimen that can be easily combined with pulsed targeted therapy. The result would be all-oral outpatient combination regimens with a favorable therapeutic index.

In Phase 1 clinical trials, anti-cancer effects of entinostat (SNDX-275) were demonstrated across a range of doses and regimens in heavily pretreated patients with advanced solid tumors and lymphomas as well as hematologic malignancies. In those studies, it was generally very well tolerated at the dose and regimen comparable to that selected for evaluation in Phase 2 clinical trials.

entinostat (SNDX-275) is being developed in combination with other agents, which are approved for the treatment of various cancers.

Syndax acquired worldwide development and commercial rights to entinostat (SNDX-275) (formerly MS-275) from Bayer Schering Pharma AG in April 2007.