On December 1, 2015 Syndax Pharmaceuticals reported the initiation of the entinostat clinical program in Japan by its partner Kyowa Hakko Kirin, Co., Ltd (Press release, Syndax, DEC 1, 2015, View Source [SID:1234508552]). Entinostat, an oral, small molecule drug candidate that targets both cancer cells and immune regulatory cells, is being developed by Syndax as an immuno-oncology therapeutic and evaluated as a treatment for advanced hormone receptor positive (HR+) breast cancer in an ongoing Phase 3 clinical trial (designated E2112) in the United States. In September 2013, entinostat was granted breakthrough therapy designation by the U.S. Food and Drug Administration in advanced HR+ breast cancer following positive results from the Phase 2b clinical trial, ENCORE-301.
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"In addition to the entinostat immuno-oncology combination regimens entering clinical development in the U.S., we are pleased to see continued clinical progress for entinostat in advanced breast cancer both in the U.S. and Japan," said Briggs Morrison, M.D., Chief Executive Officer of Syndax. "We view this milestone as an important step towards potentially providing new treatment options to breast cancer patients globally and look forward to continuing our collaboration with our valued partner Kyowa Hakko Kirin."
In January 2015, Syndax announced completion of a license agreement with Kyowa Hakko Kirin for the exclusive rights to develop and commercialize entinostat in Japan and Korea. Kyowa Hakko Kirin has now dosed the first patient in Japan in a Phase 1 clinical trial investigating the safety of entinostat (designated KHK2375 by Kyowa Hakko Kirin) as a monotherapy and in combination with exemestane in advanced or metastatic HR+ breast cancer patients previously treated with a nonsteroidal aromatase inhibitor. Secondary endpoints include pharmacokinetic parameters and preliminary efficacy.