HDAC Inhibitor Mysteries Remain As Candidates Advance
This article was originally published in Pharmaceutical Approvals Monthly
With more than a dozen candidates in the clinic and a range of indications expanding outside oncology, the histone deacetylase inhibitor class could be poised to make major inroads. But much remains to be learned about the activity, and companies are scrambling to find biomarkers.
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Merck could pay up to $167m to try a new epigenetic target, which would build on its existing HDAC inhibitor. Meanwhile, Celgene buys epigenetics-focused Acetylon, which will spin out new company Regenacy to work with its lead HDAC6 inhibitor outside of oncology.
Pharmacyclics and Servier decided to just be friends, leaving the biotech on the hook for the development of the mid-stage HDAC inhibitor abexinostat.
Positive Phase III findings support Novartis’ plan for filing the pan-DAC inhibitor in 2014. The firm’s initial BLA for the compound, seeking accelerated approval in Hodgkin’s lymphoma, was rejected by FDA in 2011.