CAMBRIDGE, MA, USA I October 19, 2021 I ONO PHARMA USA, INC. (President and CEO, Kunihiko Ito) announced the initiation of a Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody, in patients with relapsed or refractory T-cell Lymphoma in the U.S.

This study is a multicenter, open label, dose escalation Phase 1 study to evaluate ONO-4685 in patients with relapsed or refractory T-cell lymphoma (ONO-4685-03). For more information, please visit the following website at (NCT05079282).

“We are excited to initiate the Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody with a novel mechanism of action, and hope that ONO-4685 will provide benefit to the patients with relapsed or refractory T-cell lymphoma in the U.S. one day,” said Masahiro Katayama, Executive Vice President, US/EU Head of Clinical Development, ONO PHARMA USA, INC.

About T-cell Lymphoma 

T-cell lymphomas are rare types of cancer, which are categorized as tumors of mature T-cell or natural killer (NK)-cell origin and comprise approximately 10 to 15% of non-Hodgkin’s lymphoma (NHL). T-cell lymphoma can develop in lymphoid tissues and/or outside of lymphoid tissues such as liver, skin, blood and others. The main subtypes of T-cell lymphoma are peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) which have a poorer prognosis than that seen in most B-cell NHL subtypes. Therefore, new treatment options are needed to improve patient outcomes for patients with T-cell lymphoma.

About ONO-4685 

ONO-4685 is an investigational anti-PD-1/CD3 bispecific antibody, which binds specifically to human PD-1 and CD3 being developed as a potential treatment of both autoimmune diseases and hematologic malignancies. PD-1 is an inhibitory receptor specifically expressed and increased on activated T and B cells. In addition, PD-1 is expressed on malignant T-cells in some subtypes of Tcell lymphomas. CD3 is a component protein of the T-cell receptor. CD3-bispecific antibody therapy is one of cancer immunotherapy approaches and engages T-cells with malignant cells, consequently inducing anti-tumor activity. Based upon the non-clinical study data, ONO-4685 has the potential to be active against T-cell lymphomas.


ONO PHARMA USA, INC. (“OPUS”), established in 1998 as the U.S. subsidiary of Ono Pharmaceutical Co., Ltd. (“Ono”), is pursuing the clinical development of new drug candidates and aiming to establish its operation from the clinical development until the regulatory approval of products for commercialization in the U.S. In addition, OPUS has been engaged in promotion of the discovery alliances and licensing activities to expand Ono’s development pipeline and to pursue the commercialization opportunities in the U.S. For more information, please visit the company’s website at