January 8, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Kyowa Hakko Kirin Co and Syndax Pharmaceuticals said today that they will enter into a licensing agreement for breakthrough breast cancer drug entinostat, a deal which will give Kyowa Hakko Kirin exclusive rights to the drug in Japan and Korea to the tune of $100 million upfront, as well as built in milestone payments.
Waltham, Mass.-based Syndax has been developing entinostat, an oral, Class I selective histone deacetylase (HDAC) inhibitor, in the United States and Europe as a potent combo for cancers that have so far been resistant to hormone therapy used to treat advanced breast cancer. It has also been looking at ways to use the drug with immune therapy combinations to treat solid tumors.
The deal announced Thursday will give Syndax $100 million, including an upfront fee of $25 million, and an undisclosed amount of equity investment and potential development and commercial milestone payments. As part of the terms, Syndax will manufacture and supply the product to Kyowa Hakko Kirin for the duration of the contract.
Kyowa Hakko Kirin said in a statement it is planning to initiate clinical trials in 2015. The company is perhaps best known in the pharma world for its oncology, nephrology and immunology/allergy pipeline.
“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, executive officer and director of the 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.”
Entinostat has attracted a lot of attention since the U.S. Food and Drug Administration designated it a Breakthrough Therapy when used in combination with exemestane in HR+ advanced (locally advanced or metastatic) breast cancer. Syndax is currently holding Phase III clinical study for the treatment trials of that combo to see how well it works when treating hormone receptor-positive metastatic breast cancer in the U.S. Syndax currently holds all other rights to entinostat in all major markets.
That momentum is good news for both the company and breast cancer patients, said Arlene Morris, president and chief executive officer of Syndax, in a statement.
“Since we have already begun a registration-directed Phase III 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,” said Morris. “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. Syndax is very pleased to be able to collaborate with KHK, a company with a strong track record of developing important therapeutic products.”
