SAR448501 / Dren Bio, Sanofi - LARVOL DELTA

DR-0201-AIM-001: A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: Sanofi | N=36 ➔ 62 | Trial completion date: Dec 2026 ➔ Jun 2029 | Trial primary completion date: Dec 2026 ➔ Jun 2029

Enrollment change • Pan tumor • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

DR-0201-ONC-001: A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Sanofi | N=48 ➔ 96 | Trial completion date: Dec 2026 ➔ Feb 2028 | Trial primary completion date: Apr 2026 ➔ Jan 2028

Enrollment change • Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Press Release: Sanofi completes acquisition of DR-0201 (GlobeNewswire) - "Sanofi announces the completion of its acquisition of DR-0201...from Dren Bio, Inc., a private clinical-stage biopharmaceutical company. The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline....Sanofi acquired DR-0201 through the acquisition of the Dren Bio affiliate Dren 0201, Inc. for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievements of certain development and launch milestones."

M&A • Immunology • Lupus

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