DR-0201 / Dren Bio - LARVOL DELTA

Sanofi Inks $1.9B Deal With Dren Bio to Buy Autoimmune Disease Drug (Yahoo Finance) - "Sanofi SNY announced that it signed an agreement with California-based privately held biopharmaceutical company Dren Bio to acquire the latter’s investigational bispecific antibody DR-0201...Sanofi believes that DR-0201 has the potential to reset the immune system, which can lead to sustained treatment-free remission in patients with refractory B-cell-mediated autoimmune diseases, like lupus. The company’s decision to acquire DR-0201 stems from the deep and robust B-cell depletion response seen across ‘pre-clinical and early clinical studies.’....Per the terms of the deal, Sanofi will pay $600 million as an upfront payment to Dren Bio. The California-based company will also be eligible to receive up to $1.3 billion in potential milestone payments. The transaction, which is expected to close in the second quarter of 2025, will be financed by Sanofi using its available cash resources."

Commercial • Lupus • Non-Hodgkin’s Lymphoma

DR-0201-AIM-001: DR-0201 in Subjects With Autoimmune Diseases (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Cutaneous Lupus Erythematosus • Dermatomyositis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

DR-0201-AIM-001: DR-0201 in Subjects With Autoimmune Diseases (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial • Pan tumor • Cutaneous Lupus Erythematosus • Dermatomyositis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Dren Bio | Recruiting ➔ Completed | N=48 ➔ 10

Enrollment change • Trial completion

DR-0201-ONC-001: A Study of DR-0201 in Subjects With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

DR-0201-ONC-001: A Study of DR-0201 in Subjects With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Dren Bio

Trial completion date

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Dren Bio | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Dren Bio

New P1 trial