Entinostat is a novel, oral small molecule inhibitor of class I histone deacetylases, key enzymes that alter the structure of chromatin to control gene expression. Entinostat is differentiated from other members of the class through its unique selectivity profile, pharmacokinetic properties and safety profile.

Entinostat has been studied in more than 600 cancer patients where objective tumour responses have been observed in both solid and haematologic malignancies. Randomized, placebo-controlled phase 2 studies with entinostat have demonstrated promising results in combination with aromatase inhibitors in breast cancer (ENCORE 301) and with the EGFR-TKI erlotinib (ENCORE 401) in non-small cell lung cancer. Results from the ENCORE clinical program have provided the basis for moving entinostat in pivotal, phase 3 testing across a platform of breast and lung cancer indications.

Joanna Horobin, MD, president and chief executive officer, Syndax, said: “Syndax is pleased to partner with Ventana, a world leader and innovator of tissue-based diagnostic solutions for patients worldwide, as we advance the development of entinostat in NSCLC.” “In ENCORE 401, a randomized, phase 2 study comparing erlotinib plus entinostat to erlotinib plus placebo, the subset of patients with tumours expressing high levels of the protein E-cadherin experienced a more favourable overall survival and we therefore intend to select this patient population in the confirmatory study planned to start in the second half of the year.”

Data from ENCORE 401 presented most recently at the 2011 World Conference on Lung Cancer indicated that a subset of advanced non-small cell lung cancer patients expressing high levels of the protein e-cadherin in their tumours derived a 4-month survival advantage with the combination treatment versus erlotinib plus placebo (HR 0.35 [95% CI:0.13-0.92] p=0.03).

In 2010, Ventana developed and launched an in vitro diagnostic kit for use on VENTANA platforms to measure levels of E-cadherin in epithelial tissues. Ventana plans to validate the assay in its own in-house CAP/ CLIA certified laboratory and may then serve as the central laboratory for the upcoming Syndax clinical trial.

"We are very pleased to be the companion diagnostic partner of choice for Syndax to collaborate on this important project,” said Ventana president, Mara G. Aspinall. “The plan to develop a companion diagnostic for entinostat shows that our companies are aligned in their commitment to advancing personalized healthcare to improve the lives of patients afflicted with cancer."

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