Syndax announces further entinostat collaboration with Roche

Syndax Pharmaceuticals has announced a new collaboration with Roche’s Genentech unit dedicated to combining small molecule cancer drug entinostat with the latter’s immunotherapy, Tecentriq.

The two companies will look at the combination of entinostat, an oral class 1 HSAC inhibitor and Tecentriq (atezolizumab) in patients with second line hormone receptor positive, human epidermal growth factor negative (HR+, HER2-) metastatic breast cancer.

The companies are hoping this combination therapy will help women who have not responded to drugs from the recently approved CDK4/6 inhibitor class, including Pfizer’s Ibrance and Novartis’ Kisqali.

The companies already work together looking at other uses for entinostat, and Genentech will conduct the phase 1b/2 open-label trial, as part of Roche’s Morpheus immunotherapy development platform.

This is an adaptive platform that aims to develop combinations of cancer immunotherapies more rapidly and efficiently.

Entinostat has already been granted a Breakthrough Therapy designation by the FDA following positive results from the phase 2b clinical trial, ENCORE 301.

It is being evaluated in a phase 3 clinical trial in combination with exemestane for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer

Syndax also has a separate collaboration with Genentech for ENCORE 602, a trial examining safety, tolerability and clinical activity of entinostat in combination with Tecentriq in triple-negative breast cancer.

The phase 2 portion of  ENCORE 602 is expected to complete enrolment in the first half of this year.

Syndax is run by CEO Briggs Morrison, who was formerly head of medicines development at AstraZeneca for three years, before taking over at Syndax in 2015.

Syndax CEO Briggs Morrison

Morrison said: “This collaboration represents further validation of the ongoing interest to test the potential ability of Syndax’s entinostat to enhance the effectiveness of an immuno-oncology therapy in an area of unmet medical need.”

“While checkpoint inhibitors have shown initial promise in triple-negative breast cancer, there is a clear need to augment the effectiveness of such therapies in the setting of HR+, HER2- breast cancer.”


The drug is also being tested in early stage cancer trials with Merck’s immunotherapy drug, Keytruda and Merck KGaA/Pfizer’s Bavencia, as it is thought to block the function of immune suppressive cells near to tumours.

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