ONO, Gilead to Develop BTK Inhibitor

ONO Pharmaceutical and Gilead Sciences have entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO’s oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases.

ONO will receive an upfront payment plus certain development, regulatory and commercial milestones. The companies will jointly development ONO-4059. Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where ONO retains development and commercialization rights.

ONO-4059 is a selective, once-daily, oral inhibitor of BTK, which has been shown to play a role in the survival and proliferation of malignant B-cells. Preliminary Phase 1 data shows clinical activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). ONO and Gilead plan to develop ONO-4059 for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents.

“We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059,” said Gyo Sagara, ONO’s president, representative director and chief executive officer. “Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of ONO-4059 with Gilead.”

“With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies – PI3K delta, Syk, JAK and BTK,” said Norbert W. Bischofberger, PhD, Gilead’s executive vice president, R&D and chief scientific officer. “In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead’s other kinase inhibitors with a goal of achieving more pronounced and more durable response rates. We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible.”