DR-01 / Dren Bio - LARVOL DELTA

Initial clinical data from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with large granular lymphocytic leukemia (ASH 2025) - P1/2 | "Prior therapies includedmethotrexate in 29 (94%), cyclophosphamide in 15 (48%), cyclosporine in 13 (42%), and alemtuzumab in 4(13%), with 17 (55%) pts also receiving some other treatment including investigational agents. Preliminary safety and efficacy data show that DR-01 is well-tolerated with a promisingresponse rate and durable responses, supporting continued development of DR-01 as a therapy forLGLL."

Clinical data • P1 data • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • CD8 • GZMB • KLRD1

Updated clinical data and biomarker analyses from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with relapsed/refractory cytotoxic lymphomas (ASH 2025) - P1/2 | "DR-01 continues to demonstrate promising safety and efficacy, supporting its developmentas a potential treatment option for CTL. Biomarker analyses show that CD94 is widely expressed acrossmost CTL. Notably, the preliminary data suggest that patients with CTL may benefit from DR-01regardless of baseline positive CD94 expression by IHC."

Biomarker • Clinical data • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD8 • GZMB • KLRD1

Results from the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients with Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization (ASH 2024) - P1/2 | "An encouraging response rate including 3 durable CRs points to the potential for DR-01 as a viable treatment option for CTL. Study DR-01-ONC-001 is currently enrolling an international cohort of patients with CTL into phase 2, part B2 of the trial."

Clinical • P1 data • Bone Marrow Transplantation • Constipation • Extranodal Natural Killer/T-cell Lymphoma • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Oncology • CD8 • KLRD1

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Dren Bio | Active, not recruiting ➔ Completed

Trial completion

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Dren Bio | Recruiting ➔ Active, not recruiting

Enrollment closed

FIRST-IN-HUMAN PHASE 1 STUDY OF DR-01, A NON-FUCOSYLATED ANTI-CD94 ANTIBODY IN PATIENTS WITH RELAPSED/REFRACTORY CYTOTOXIC LYMPHOMAS: DOSE ESCALATION AND OPTIMIZATION (ICML 2025) - P1/2 | "DR-01 demonstrates promising safety and efficacy, supporting its development as a potential treatment option for CTL."

Clinical • P1 data • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD8 • KLRD1

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Dren Bio | N=60 ➔ 80

Enrollment change • Alopecia • Dermatology • Immunology • Vitiligo

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas (clinicaltrials.gov) - P1/2 | N=69 | Recruiting | Sponsor: Dren Bio | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Study of Subcutaneous DR-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial

City of Hope Reveals New Data on Cancer Immunotherapies, Microbiome and Other Innovative Topics at 2024 American Society of Hematology (ASH) Annual Meeting (Businesswire) - "City of Hope....announced today that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH annual meeting from Dec. 7 to 10 in San Diego."

Clinical data

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Alopecia • Dermatology • Immunology • Vitiligo

A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial • Alopecia • Dermatology • Immunology • Vitiligo

DR-01, a Non-Fucosylated Anti-CD94 Antibody, Depletes Leukemic Cells in Ex Vivo and In Vivo Models of Large Granular Lymphocyte Leukemia (ASH 2022) - "In addition, treatments are limited to standard immunosuppressive therapy such as methotrexate, cyclosporine or cyclophosphamide, with complete response rates of only 50% or less for each agent. Additional profiling and evaluation of DR-01 in LGLL patient samples ex vivo as part of a pre-phase I study is ongoing. A phase I/II trial has been initiated to assess the safety and efficacy of DR-01 in previously treated LGLL patients."

Preclinical • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Thrombocytopenia • B3GAT1 • CD8 • FCGR3A • KLRC1 • LAMP1 • PTPRC

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas (clinicaltrials.gov) - P1/2 | N=69 | Recruiting | Sponsor: Dren Bio

New P1/2 trial • Cutaneous T-cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma