Zenas Biopharma (USA) LLC

Address: 852 Winter Street Suite 250

Sponsor Overview

assignment

Specializations

Autoimmune and Immune-Mediated Disease

Zenas Biopharma (USA) LLC funds clinical research in IgG4-related disease, systemic lupus erythematosus, and warm autoimmune hemolytic anemia, with a clear focus on conditions driven by immune dysregulation and inflammatory activity.

IgG4-related disease
Systemic lupus erythematosus
Warm autoimmune hemolytic anemia

Its research interests include disease control, flare prevention, anemia-related outcomes, and the management of immune-mediated tissue involvement.

Multiple Sclerosis

The sponsor supports studies in both relapsing multiple sclerosis and primary progressive multiple sclerosis, reflecting involvement across distinct forms of chronic neurologic disease.

Relapsing multiple sclerosis
Primary progressive multiple sclerosis

Areas of interest include lesion suppression, disability progression, and broader neurologic disease activity in multiple sclerosis.

B-cell and Immune Pathway Modulation

Across its portfolio, the company’s clinical activity is centered on therapies targeting immune signaling pathways relevant to B-cell-mediated disorders and other autoimmune diseases.

B-cell-related immune modulation
Autoimmune disease activity control
Inflammatory disease management

This includes therapeutic interest in reducing pathologic immune activation and improving organ-specific and systemic disease manifestations.

Hematologic Autoimmunity

Clinical research in warm autoimmune hemolytic anemia highlights the sponsor’s interest in immune-driven blood disorders, especially those affecting red blood cell survival and anemia burden.

Autoimmune hemolysis
Anemia outcomes
Rescue therapy reduction

The therapeutic emphasis includes restoration of hemoglobin response and control of clinically significant hemolytic activity.

Sponsored Trials

Trial Name	Country	Status
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH IGG4-RELATED DISEASE (INDIGO)	France Germany Hungary Italy Poland Spain Sweden The Netherlands	Not Recruiting
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, WITH A SAFETY AND DOSE CONFIRMATION RUN-IN PERIOD, TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA (SAPHIARE)	Italy Poland Spain	Not Recruiting
Efficacy and Safety Evaluation of Obexelimab in Relapsing Multiple Sclerosis: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study	Austria Belgium Croatia Czechia Denmark Finland Greece Italy Poland Spain	Not Recruiting
Efficacy and Safety Evaluation of Obexelimab in Systemic Lupus Erythematosus: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial	Belgium Bulgaria Denmark Germany Greece Italy Poland Portugal Romania Spain	Not Recruiting
Phase 3 Randomized Double-Blind Study of Orelabrutinib for Primary Progressive Multiple Sclerosis in Patients With PPMS	Austria Belgium Bulgaria Croatia Czechia Denmark Estonia Finland France Germany Greece Hungary Italy Poland Portugal Romania Slovakia Spain Sweden The Netherlands	Recruiting
Phase 3 Randomized Double‑Blind Study of Orelabrutinib vs Placebo on Disability Progression in Non‑Active Secondary Progressive Multiple Sclerosis	Austria Belgium Bulgaria Croatia Czechia Denmark Estonia France Germany Greece Hungary Italy Lithuania Norway Poland Portugal Romania Slovakia Spain Sweden The Netherlands	Recruiting