besufetamig (ONO-4685) / Ono Pharma, Merus - LARVOL DELTA

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma (clinicaltrials.gov) - P1 | N=217 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Trial completion date: Jun 2026 ➔ Mar 2027 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Monotherapy • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

ONO-4685: A novel PD-1/CD3 bispecific T-cell engager (TCE) for the treatment of T-cell malignancies (AACR 2025) - P1 | "ONO-4685 treatment showed suppressive effects on tumor growth in a dose-dependent manner.Taken together, these preclinical data support the clinical development of ONO-4685 as a novel TCE targeting PD-1 expressing hematologic malignancies. A Phase I clinical study in the USA is ongoing to evaluate the safety and tolerability of ONO-4685 in relapsed or refractory patients with PTCL and CTCL (NCT05079282)."

IO biomarker • Adult T-Cell Leukemia-Lymphoma • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4 • CD8 • GZMB • PD-1

Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685 (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Ono Pharmaceutical Co. Ltd | Suspended ➔ Completed | N=74 ➔ 33 | Trial completion date: Dec 2025 ➔ Jul 2024 | Trial primary completion date: Oct 2024 ➔ Jul 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd

Monotherapy • New P1 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma

Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685 (clinicaltrials.gov) - P1 | N=74 | Suspended | Sponsor: Ono Pharmaceutical Co. Ltd | Recruiting ➔ Suspended

Trial suspension • Dermatology • Immunology • Psoriasis

Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685 (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Suspended ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • CD4 • CD8 • IL10 • IL2 • IL6

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma (clinicaltrials.gov) - P1 | N=217 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | N=86 ➔ 217

Enrollment change • Monotherapy • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685 (clinicaltrials.gov) - P1 | N=96 | Suspended | Sponsor: Ono Pharmaceutical Co. Ltd | Recruiting ➔ Suspended

Trial suspension • Dermatology • Immunology • Psoriasis • CD4 • CD8 • IL10 • IL2 • IL6

Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685 (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd

New P1 trial • Dermatology • Immunology • Psoriasis • CD4 • CD8 • IL10 • IL2 • IL6 • TNFA

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma (clinicaltrials.gov) - P1; N=86; Recruiting; Sponsor: Ono Pharmaceutical Co. Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects (clinicaltrials.gov) - P1; N=78; Completed; Sponsor: Ono Pharmaceutical Co. Ltd; Active, not recruiting ➔ Completed; N=168 ➔ 78; Trial completion date: Sep 2021 ➔ May 2021; Trial primary completion date: Sep 2021 ➔ May 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma (clinicaltrials.gov) - P1; N=86; Not yet recruiting; Sponsor: Ono Pharmaceutical Co. Ltd

Clinical • Monotherapy • New P1 trial • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

ONO PHARMA USA Announces Initiation of 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 (PRNewswire) - "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)."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects (clinicaltrials.gov) - P1; N=168; Active, not recruiting; Sponsor: Ono Pharmaceutical Co. Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects (clinicaltrials.gov) - P1; N=168; Recruiting; Sponsor: Ono Pharmaceutical Co. Ltd; Trial completion date: May 2021 ➔ Sep 2021; Trial primary completion date: May 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date