Kyowa Hakko Kirin Co., Ltd., (Headquarters: Chiyoda-ku, Tokyo; president and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") and Syndax Pharmaceuticals, Inc., (Waltham, Mass.; president and CEO: Arlene M. Morris, "Syndax") today jointly announced that the companies have entered into a license agreement for the exclusive rights to develop and commercialize entinostat in Japan and Korea. Entinostat is a Class I selective histone deacetylase (HDAC) inhibitor being developed by Syndax in the United States and Europe in combination with hormone therapy for advanced breast cancer and immune therapy combinations in solid tumors.
Under the terms of the agreement, Kyowa Hakko Kirin will pay Syndax a total of up to $100 million including an upfront fee of $25 million with a certain amount of an equity investment and potential development and commercial milestone payments. Syndax will manufacture and supply the product to Kyowa Hakko Kirin during the term of the agreement.
"We are pleased to enter into a partnership with Syndax to develop Entinostat in Japan and Korea. Entinostat has great potential to treat a cancer with a mode of action modifying epigenetics," stated Masashi Miyamoto, Ph.D., Executive Officer, Director, Strategic Product Portfolio Department of Kyowa Hakko Kirin. "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."
Arlene Morris, president and chief executive officer of Syndax, said, "Since we have already begun a registration-directed Phase 3 trial in breast cancer in the U.S., 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 2 trial and underscored by the FDA designating entinostat a Breakthrough Therapy when combined with exemestane in postmenopausal women with HR+ metastatic breast cancer. Syndax is very pleased to be able to collaborate with KHK, a company with a strong track record of developing important therapeutic products."
Kyowa Hakko Kirin is planning to initiate clinical trials in 2015.
First UK real-world study shows promise for sacituzumab govitecan in metastatic breast cancer