Ono, Gilead Partner On Treatments For B-cell Malignancies

Ono Pharmaceutical and Gilead Sciences have partnered on ONO-4059. The companies announced the deal in a press release, stating that the Bruton’s tyrosine kinase (BTK) inhibitor is for the treatment of B-cell malignancies and other diseases. The joint development deal provides a structure for global marketing. Norbert W. Bischofberger, PhD, Gilead’s EVP of research and development and CSO, said, “With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies – PI3K delta, Syk, JAK, and BTK.”

Ono and Gilead Agreement

Under the terms of the agreement between Ono and Gilead, investigators will evaluate ONO-4059 as a single agent, in combination, and in comparison with standard of care treatments. Gilead states that the agent may work with its other kinase inhibitors. Gilead has agreed to make an upfront payment and additional payments based on development, regulatory, and commercial milestones. Both companies will participate in development efforts, and Gilead is authorized to commercialize the agent worldwide, except for Japan, South Korea, Taiwan, China, and the Association of Southeast Asian Nations (ASEAN) countries.

ONO-4059

ONO-4059 is a once-daily, oral agent that affects malignant B-cell proliferation. Bruton’s tyrosine kinase plays a role in signal transduction, influencing anti-tumor activities. Ono’s Phase 1 data shows activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). In an abstract presented at the 2014 ASCO Annual Meeting, Ono showed in a Phase 1 study that in 13 lymphoma patients administered monotherapy with ONO-4059, the agent was well tolerated. In that study, six patients had reductions in lymphadenopathy within the first treatment cycle. In a hard-to-treat patient group, ONO-4059 showed efficacy and safety.

Ono Activities

Ono has been active in partnering, making deals with other pharmaceutical companies, such as Bristol Myers Squibb (BMS), with whom it is working on immunotherapies for oncology indications. In December 2014, Ono, BMS, and Kyowa Hakko Kirin partnered on a Phase 1 combination study. Ono announced the deal in a press release, stating that that trial will administer Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody. The study in Japan will evaluate safety, tolerability, and anti-tumor activity of the combination in patients with advanced or metastatic solid tumors.