Japan-based Kyowa Hakko Kirin (KHK) has signed a license agreement with US-based Syndax Pharmaceuticals for the exclusive rights to develop and commercialise entinostat in Japan and Korea.
Entinostat is a class I selective histone deacetylase (HDAC) inhibitor, which is being developed by Syndax in the US and Europe, in combination with hormone therapy to treat advanced breast cancer and immune therapy combinations in solid tumours.
Kyowa Hakko Kirin strategic product portfolio department director Masashi Miyamoto said: "Entinostat has great potential to treat a cancer with a mode of action modifying epigenetics.
"We believe that Entinostat could deliver a lot of benefit to breast and other cancer patients, which lead to strengthen KHK’s future oncology portfolio."
As part of the deal, Syndax will receive a total of up to $100m from Kyowa Hakko, including an upfront fee of $25m with a certain amount of equity investment and potential development and commercial milestone payments.
During the tenure of the agreement, Syndax will manufacture and supply the product to KHK. Kyowa Hakko plans to commence clinical trials for entinostat in 2015.
Syndax Pharmaceuticals president Arlene Morris said: "Since we have already begun a registration-directed Phase III trial in breast cancer in the US, it’s important and timely to enter into this agreement with KHK to initiate development in order to bring entinostat to breast cancer patients in Japan and Korea.
"The expansion of the global development effort further validates the importance of prolonging survival in metastatic breast cancer as observed in our Phase II trial and underscored by the FDA designating entinostat a breakthrough therapy when combined with exemestane in postmenopausal women with HR+ metastatic breast cancer."
Image: Metastatic breast cancer in pleural fluid. Photo: courtesy of Ed Uthman, from Houston, US.