On October 19, 2021 ONO PHARMA USA, INC. (President and CEO, Kunihiko Ito) reported 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 (Press release, Ono, OCT 19, 2021, View Source [SID1234591535]).

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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 View Source (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.